The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

Figures & data

Table 1 Quality of Evidence Ranking Using United States Preventative Services Task Force Criteria Modified for Interventional Spine Procedures

Grade	Definition	Suggestions for practice
A	The ASPN Back Group recommends the service. There is high certainty that the net benefit is substantial.	Offer or provide this service.
B	The ASPN Back Group recommends the service. There is high certainty that the net benefit is moderate or there is moderate certainty that the net benefit is moderate to substantial.	Offer or provide this service.
C	The ASPN Back Group recommends selectively offering or providing this service to individual patients based on professional judgment and patient preferences. There is at least moderate certainty that the net benefit is small.	Offer or provide this service for selected patients depending on individual circumstances.
D	The ASPN Back Group recommends against the service. There is moderate or high certainty that the service has no net benefit or that the harms outweigh the benefits.	Discourage the use of this service.
I Statement	The ASPN Back Group concludes that the current evidence is insufficient to assess the balance of benefits and harms of the service. Evidence is lacking, of poor quality, or conflicting, and the balance of benefits and harms cannot be determined.	Read the clinical considerations section of USPSTF Recommendation Statement. If the service is offered, patients should understand the uncertainty about the balance of benefits and harms.

Abbreviation: ASPN, American Society of Pain and Neuroscience.

Table 2 Levels of Certainty Regarding Net Benefit

Level of certainty	Description
High	The available evidence includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. Evidence Level: I-A - At least one controlled and randomized clinical trial, properly designed
Moderate	The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as: The number, size, or quality of individual studies. Inconsistency of findings across individual studies. Limited generalizability of findings to routine primary care practice. Lack of coherence in the chain of evidence. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. Evidence Level I-B - Well-designed, controlled, non-randomized clinical trials (Prospective Observational studies conforming to STROBE criteria) or Evidence Level I-C - Retrospective cohort or large case studies (>20 subjects)
Low	The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of: The limited number or size of studies. Important flaws in study design or methods. Inconsistency of findings across individual studies. Gaps in the chain of evidence. Findings not generalizable to routine primary care practice. Lack of information on important health outcome Evidence Level II - Expert opinion based of risk-to-benefit or based upon case reports

Abbreviation: STROBE, Strengthening the Reporting of Observational Studies in Epidemiology.

Table 3 Evidence Summary for Epidural Steroid Injections

Study author	Study type	Study size	Endpoints	Evidence level	Notes
Ghai et al^Citation7	RCT	69	NRS	I-A	Comparing lidocaine versus lidocaine Mixed with methylprednisolone
Manchikanti et al^Citation408	RCT	70	NRS	I-A	Comparing local anesthetic only or with local anesthetic mixed with non-particulate betamethasone
Gharibi et al^Citation409	RCT	42	NRS	I-A	Comparing interlaminar versus transforaminal epidural steroid injections
Ng et al^Citation410	RCT	86	NRS	I-A	Comparing bupivacaine versus bupivacaine and methylprednisolone
Manchikanti et al^Citation411	RCT	120	NRS	I-A	Testing effectiveness of transforaminal epidural injections of local anesthetic with or without steroids
Iversen et al^Citation412	RCT	461	NRS	I-A	Interventions Subcutaneous sham injections of 2 mL 0.9% saline, caudal epidural injections of 30 mL 0.9% saline, and caudal epidural injections of 40 mg triamcinolone acetonide in 29 mL 0.9% saline. Participants received two injections with a two-week interval.
Nandi et al^Citation413	RCT	93	VAS	I-A	Comparing steroids versus conservative treatment
Cohen et al^Citation414	RCT	145	NRS	I-A	Comparing steroids versus conservative treatment
Vad et al^Citation415	RCT	48	VAS	I-A	Comparing steroids versus conservative treatment
Buchner et al^Citation416	RCT	40	VAS	I-A	Comparing steroids versus conservative treatment

Abbreviations: RCT, randomized controlled trial; NRS, numeric rating scale; VAS, visual analog scale.

Table 4 ASPN Back Consensus Group Recommendations for Epidural Steroid Injections

Recommendation	Grade	Level	Level of certainty Net benefit
Interlaminar epidural injections for treatment of low back and radicular pain originating from disc disease, spinal stenosis and for chronic back/leg pain after surgical intervention	A	I-A	High
Transforaminal epidural injections for treatment of low back and radicular pain originating from disc disease, spinal stenosis and for chronic back/leg pain after surgical intervention	A	I-A	High
Caudal epidural injections for treatment of low back and radicular pain originating from disc disease, spinal stenosis and for chronic back/leg pain after surgical intervention when interlaminar or transforaminal approaches are not feasible	A	I-A	High
Use of either steroid or local anesthetic or the two classes of medication in combination for use in epidural injections for treatment of low back and radicular pain originating from disc disease, spinal stenosis and for chronic back/leg pain after surgical intervention	A	I-A	High

Table 5 Evidence Summary for Trigger Point Injections

Study author	Study type	Study size	Endpoints	Evidence level	Notes
Roldan et al^Citation417	RCT	48	NRS	I-A	Comparing local anesthetic and steroid TPI to saline TPI in ED patients. Resulted in similar change in pain relief in both groups.
Sakalys et al^Citation418	RCT	50	VAS	I-A	Comparing platelet rich plasma injection versus TPI for myofascial pain. Better pain relief 4 weeks out with platelet rich plasma injection.
Moon et al^Citation419	Double blind RCT	136	VAS, 5-point Likert Scale	I-A	Comparing TPI with and without vibration therapy. Vibration therapy during TPI decreased pain during injection compared to without vibration therapy
Dessie et al^Citation420	Double blind RCT	59	VAS, PFDI-20	I-A	Comparing saline or Botox TPI for abdominal MPS in pelvic pain. No difference between groups
Ata et al^Citation421	RCT	76	VAS, SF-12	I-A	Determining if kinesiology tape prolonged TPI effects. Study found that it did prolong TPI relief.
Pecos-Martin et al^Citation422	Double blind RCT	72	VAS, NPQ, PPT	I-A	Comparing dry needling near a trigger point or directly into a trigger point. Dry needling into a trigger point is more beneficial.
Kwanchuay et al^Citation423	Double blind RCT	33	VAS, PPT	I-A	Comparing Botox to saline TPI. No difference between the two groups.
Choi et al^Citation424	RCT	21	VAS, PPT, SF-MPQ	I-A	Determining if transcranial direct current stimulation worked in making TPI more effective. Study indicates that it does.
Seo et al^Citation425	Double blind RCT	76	VAS, NPAD, GAS, PPT	I-A	Comparing performing Botox TPI with motor electrical stimulation or sensory stimulation guidance. Sensory stimulation found to be more helpful.
Yoon et al^Citation426	RCT	77	VAS, NDI, SF-36	I-A	Comparing needle sizes on injection pain. No difference noted between sizes of needles used.
Ga et al^Citation427	RCT	39	VAS, FACES, PPI, GDS-SF	I-A	Comparing TPI with acupuncture for MPS. No difference seen between groups.
Zaralidou et al^Citation428	RCT	68	-	I-A	Comparing ropivacaine to levobupivacaine for TPI, no significant differences found between groups.
Qerama et al^Citation429	Double blind RCT	30	NRS, PPDT, PPTT	I-A	Comparing Botox TPI to placebo. No difference in pain relief between groups, but Botox caused decreased electromyography activity.
Göbel et al^Citation430	Double blind RCT	145	PS	I-A	Comparing Botox to normal saline TPI. Botox was better between weeks 5–8 in this study.
Kamanli et al^Citation431	Single blind RCT	29	PPT, PS, VAS, NHP	I-A	Comparing Botox TPI to dry needling to bupivacaine TPI. TPI in general found to have better benefit than dry needling. Authors note bupivacaine was best for TPI as it was fast acting meanwhile Botox TPI should be used in medically refractory cases
Iwama et al^Citation432	RCT	21	PS	I-A	Testing injection pain with dilute local anesthetic in volunteers as well as using dilute local anesthetic doses in patients with MPS. Less pain with dilute local injections. Duration relief in MPS patients not affected by using dilute local at low enough doses.
Iwama et al^Citation433	RCT	20	PS	I-A	Comparing 0.25% to 1.0% lidocaine for TPI. 0.25% had less injection pain and better efficacy.
Krishnan et al^Citation434	RCT	30	VAS	I-A	Comparing injection pain of bupivacaine, ropivacaine, bupivacaine with steroids, ropivacaine with steroids, and just needle insertion. Ropivacaine was less painful (alone) compared to bupivacaine or either local anesthetic in combination with steroids.
Wheeler et al^Citation435	Double blind RCT	33	NPAD, PS	I-A	Comparing 50 U Botox, 100 U Botox, and normal saline TPI. All 3 groups improved pain. No statistically significant benefit of one injection type to the others.
Tschopp et al^Citation436	RCT	107	PS	I-A	Comparing 0.25% bupivacaine to 1.0% lidocaine to saline TPI. No difference in relief between groups so long as needle hits muscle belly.
Hong et al^Citation437	RCT	58	PTM	I-A	Local anesthetic TPI compared to dry needling to evaluate need for twitch response. Significant improvement in patients with twitch response compared to those without upon needle insertion
Garvey et al^Citation438	Double blind RCT	63	NRS	I-A	Comparing local anesthetic TPI, local anesthetic with steroid TPI, acupuncture, and cool spray with acupuncture. No difference between types of procedural techniques noted.
Hameroff et al^Citation439	Cross over double blind RCT	15	PS	I-A	Comparing bupivacaine to etidocaine to saline for TPI. Local preferred to saline alone.
Kocak et al^Citation440	RCT	54	VAS	I-A	Comparing NSAID and TPI for low back MPS; TPI was superior to NSAIDs when assessed with pain relief within the first hour of intervention.
Mitidieri et al^Citation50	RCT	35	VAS, NCS, MPQ	I-A	Comparing acupuncture to TPI for pelvic pain from abdominal MPS, no difference seen between outcomes when analyzed at 1 week, 1 month, 3 months, and 6 months out except for MPQ differences at 1 week.

Abbreviations: NRS, numeric rating score; VAS, visual analogue score; PFDI-20, Pelvic Floor Distress Inventory-20; SF-12/36, 12- or 36-Item Short Form Health Questionnaire; NPQ, Neck Pain Questionnaire; PPT, pressure-pain threshold; SF-/MPQ, Short Form/McGill Pain Questionnaire; NPAD, Neck Pain and Disability Scale; GAS, Global Assessment of Improvement Scale; NDI, Neck Disability Index; FACES, Wong-Baker FACES Pain Scale; PPI, pressure pain intensity scores; GDS-SF, Geriatric Depression Scale-Short Form; PPDT, pressure pain detection thresholds; PPTT, pressure pain tolerance thresholds; NHP, Nottingham Health Profile; PS, pain score (internal system); PTM, pressure threshold meter; NCS, numeric categorical scale; TPI, trigger point injections; NSAID, nonsteroidal anti-inflammatory drug.

Table 6 ASPN Back Consensus Group Recommendations for Trigger Point Injections

Recommendation	Grade	Level	Level of certainty Net benefit
The type of medication for TPI does not make a significant difference in pain outcomes	A	I-A	Strong
Eliciting a localized twitch response for needle placement predicts best outcomes	A	I-A	Strong
In medically refractory cases, TPI with BTXA may be of benefit	C	I-B	Moderate
Dilute local anesthetic concentrations may result in less injection pain	I	II	Weak
Novel injectables may be of benefit for MPS	I	II	Weak
Adjunct therapies may be of use to prolong the relief of TPI for MPS	I	II	Weak

Abbreviations: TPI, trigger point injections; BTXA, botulinum toxin type A; MPS, myofascial pain syndrome.

Table 7 Evidence Summary for Intra-Articular Facet Joint Injections

Study author	Study type	Study size	Endpoints	Evidence level	Notes
Snidvongs et al^Citation441	Blinded parallel two-arm pilot RCT.	8		Unable to recruit enough patients, no conclusions.	To evaluate the clinical effectiveness and cost-effectiveness of lumbar facet-joint injections compared with a sham procedure in patients with non-specific LBP of > 3 months’ duration.
Kennedy et al^Citation56	Double-blind, prospective, randomized, placebo-controlled trial	28		1-A	No statistically significant difference in the need for radiofrequency neurotomy (radiofrequency neurotomy) between the groups. There is no difference in mean time to radiofrequency neurotomy between saline (6.1 wks) and corticosteroid (6.5 wks) groups. There is a need for radiofrequency neurotomy.
Cohen et al^Citation36	RCT	229	NRS	1-A	This study establishes that facet blocks are not therapeutic. The higher responder rates in the treatment groups suggest a hypothesis that facet blocks might provide prognostic value before radiofrequency ablation.
Karkucak et al^Citation442	RCT	47	VAS, ODI, STAI	1-A	The ultrasound-guided local injections offer better clinical outcome in the treatment of facet syndrome compared to blind injection.
Ye et al^Citation443	RCT	10		1A	The lumbar facet joint space can be accurately demonstrated by ultrasound. The ultrasound-guided facet joint injection in the lumbar spine obtained almost the same satisfactory feasibility, accuracy and clinical efficiency compared with low dose CT. Ultrasound technique could provide the real-time monitoring.
Wu et al^Citation71	RCT	46	VAS, RMQ, ODI	1A	Both autologous PRP and LA/corticosteroid for intra-articular injection are effective, easy, and safe enough in the treatment of lumbar facet joint syndrome. However, autologous PRP is a superior treatment option for longer duration efficacy.
Ellard et al^Citation444	RCT	26	VAS		No analysis due to difficulty in recruitment
Sae-Jung et al^Citation72	RCT	99	ODI, VAS		This prospective randomized trial is to determine the effectiveness of treating lumbar facet syndrome with oral diclofenac, methylprednisolone facet joint injection or both. The combined treatment was more effective in reducing lumbar facet pain and improving the functional index than either treatment alone. This approach should be the preferred treatment.
Do et al^Citation445	RCT	60	NRS		Six months after treatment, about half of patients in both groups reported successful pain relief (pain relief of ≥50%). both IA pulsed radiofrequency (PRF) stimulation and IA corticosteroid injection (ICI) into the lumbar facet joint (LFJ) significantly relieved LFJ pain. Their effects persisted for at least 6 months after the procedure. Thus, IA PRF is a useful therapeutic option for the management of LFJ pain.
Kennedy et al^Citation70	Randomized, double blind, placebo-controlled study	56	Time to RFA, need for RFA		Intra-articular corticosteroids were not effective in reducing the need for or the time to a radiofrequency ablation of the medial branches in those with dual MBB-confirmed lumbar z-joint pain.
Joo et al^Citation69	Prospective RCT	126	Vascular uptake		A Quincke needle was related to positive IV injection at a 1.898-fold higher rate than was use of a Whitacre needle. Whitacre needles can be considered to reduce the risk of IV injection during L-MBB.

Abbreviations: RCT, randomized controlled trial; LBP, low back pain; NRS, numeric rating scale; ODI, Oswestry Disability Index; STAI, State-Trait Anxiety Inventory; VAS, visual analog scale; RMQ, Roland-Morris Disability Questionnaire; CT, computed tomography; PRP, platelet-rich plasma; LA, local anesthetic; IA, intra-articular; PRF, pulsed radiofrequency; ICI, IA corticosteroid injection; LFJ, lumbar facet joint; RFA, radiofrequency ablation; MBB, medial branch blocks.

Table 8 ASPN Back Consensus Group Recommendations for Intra-Articular Facet Injections

Recommendation	Grade	Level	Level of certainty Net benefit
Intra-articular facet steroid injections do not replace or delay the need for RFA.	C	I-A	Strong
Intra-articular facet steroid injections can be prognostic for RFA	C	I-A	Strong
In acute cases of facet mediate pain, facet steroid injections may help due to possible inflammatory component	C	I-B	Moderate
Combining facet steroid injections with oral NSAIDs can be more effective than injection therapy alone	B	II	Moderate
Image guided facet steroid injections are more effective than blind injections	A	I-A	Strong
Do not use intra-articular facet joint steroid injections as sole therapy for facet-mediated pain.	B	I-A	Strong
Whitacre needles can reduce the risk of IV injection during MBB	C	I-A	Moderate
Lumbar Medial Branch Blocks can be prognostic for RFA	A	I-A	Strong

Abbreviations: RFA, radiofrequency ablation; NSAIDs, nonsteroidal anti-inflammatory drugs; IV, intravenous; MBB, medial branch blocks.

Table 9 Evidence Summary for Intradiscal Regenerative Therapies

Study author	Study time	Study size	Endpoints	Authors conclusion	Study analysis and notes
Miller et al, 2006^Citation446 [prolo-therapy]	Prospective	76	NRS	Reductions in pain NRS were maintained in patients with uniformly moderate to severe disc desiccation at an average of 18 months. Those patients who experienced no appreciable improvement from the treatment were not worse in any sustained way	Level I-B
Akeda et al, 2017^Citation447 [PRP Releasate]	Prospective	14	Change in imaging	Lumbar radiographs no significant change in disc height. No change in T2 imaging of AF and NP. No negative affect on the matrix of degenerated IVDs. No persistent neurologic deficits.	Level I-B
Levi et al, 2016^Citation448 [PRP]	Prospective trial	22	VAS and ODI	Encouraging preliminary 6-month findings, using strict categorical success criteria, for intradiscal PRP as a treatment for presumed discogenic LBP. Randomized placebo-controlled trials are needed to further evaluate the efficacy of this treatment.	Level I-B
Tuakli-Wosornu et al, 2016^Citation77 [PRP]	RCT	47	NRS, NASS outcome questionnaire, SF-36	Those who received PRP maintained significant improvements in FRI scores through at least 1 year of follow-up.	Level I-B
Cheng et al, 2019^Citation78 [PRP]	5- to 9-year follow-up of previous RCT (Tuakli-Wosornu et al, 2016).	21	NRS, NASS outcome questionnaire, SF-36	This study shows improvements in pain and function post intradiscal injection of PRP were sustained for follow-up periods of 5–9 years following intradiscal PRP treatment for moderate-severe lumbar discogenic pain.	Level I-C
Jain et al, 2020^Citation449 [PRP]	Prospective	25	NRS, ODI	This study shows a positive correlation between platelet concentration for PRP with improvement in pain and functional status in patients receiving intradiscal PRP for chronic discogenic LBP. The authors recommend use of intradiscal PRP for treatment of discogenic pain with preferably a higher platelet count to elicit a favorable response.	Level I-C
Navani et al, 2018^Citation450 [PRP or MSCs]	Prospective case series	20	NRS, SF-36	This study supports the safety of a single intradiscal biologic injection and provides addition evidence for the efficacy in management of lumbar discogenic pain, with improvements in both pain and function, and decreased utilization of medications and medical services thereby decreasing health care costs.	Level I-C
Ju et al, 2020^Citation83 [growth factor, fibrin sealant, or stem cells]	Post hoc comparison using single-site data from 4 multicenter RCTs.	50	VAS and disability scores.	There was no difference in outcomes between therapeutic intradiscal agents (growth factor, fibrin sealant, or stem cells) and control saline groups. In all groups, patient reported pain and disability score improvements. Saline control patients demonstrated significant improvements in pain and disability at 1 year follow-up post injections. Suggests that perhaps saline injection has a therapeutic effect possibly by diluting pro-inflammatory mediators within the degenerated intervertebral disc, or decreasing of intradiscal pressure, or a combination of the placebo effect.	Level I-C
Orozco et al, 2011^Citation451 [MSCs]	Case-series pilot Phase 1 n=10	10	VAS, ODI, SF-36	MSC therapy may be a valid alternative treatment for chronic back pain caused by DDD. Advantages over current gold standards include simpler and more conservative intervention without surgery, preservation of normal biomechanics, and same or better pain relief. This outcome compares favorably with spinal fusion or total disc replacement.	Level II
Elabd et al, 2016^Citation452 [bone marrow derived MSC]	Long-term follow-up study.	5	Physical examination, low back MRI, and quality of life questionnaire.	This early human clinical data suggests the safety and feasibility of the clinical use of hypoxic cultured bone marrow derived MSCs for the treatment of LBP due to DDD and support further studies. A larger double-blind, controlled, randomized clinical study with significant number of patients and implementation of validated endpoint measurements are next steps in order to demonstrate efficacy of this biologic.	Level II
Pettine et al, 2017^Citation453 [BMC]	Prospective, open-label, non-randomized	26	ODI, VAS	There were no adverse events related to marrow aspiration or injury and this study provides evidence of safety and feasibility of intradiscal BMC therapy. No radiologic evidence of worsening. Pt. improvement and satisfaction with this surgical alternative supports further study of the therapy.	Level I-B
Centeno et al 2017^Citation454 [autologous cultured MSC]	Prospective	33	NRS, SANE, FRI, measurement of the intervertebral disc posterior dimension, and adverse events	Patients treated with autologous cultured MSCs for lower back pain with radicular symptoms in the setting of DDD reported minor adverse events and significant improvements in pain, function, and overall subjective improvement through 6 years of follow-up. 3 patients reported pain related to procedure that resolved. No serious adverse events (ie, death, infection, or tumor) with the procedure.	Level I-B
Noriega et al, 2017^Citation455 [allogeneic MSCs]	RCT	24	VAS, ODI	Feasibility and safety were confirmed, and indications of clinical efficacy were identified. Allogeneic MSC therapy may be a valid alternative for the treatment of DDD that is more logistically convenient than the autologous MSC treatment. The intervention is simple, does not require surgery, provides pain relief, and significantly improves disc quality.	Level I-B
Bae et al, 2014^Citation456 [allogeneic MPCs]	Prospective, multicenter, RCT.	100	VAS, ODI	Allogeneic MPCs were well tolerated, showed improvements in pain and functional improvement and reduced interventions compared to controls. Needs randomized Phase 3 studies. When compared to HA results did not reach statistical significance	Level I-B
Kumar et al, 2017^Citation457 [AT-MSCs and HA derivative]	Single-arm, open-label, phase I clinical trial	10	VAS, ODI, SF-36	Combined implantation of MSCs and HA derivative in chronic discogenic LBP is safe and tolerable. However, the efficacy of combined AT-MSCs and HA should be investigated in an RCT in a larger population. No procedure or stem cell-related adverse events or serious adverse events during the 1-year follow-up period.	Level I-B
Comella et al, 2017^Citation458 [SVF]	Open label study.	15	VAS, PPI, ODI, BDI, DPQ, and SF-12.	Stromal vascular fraction (SVF) proved promising, however a true evaluation of efficacy and safety would require larger phase II/III studies.	Level I-B
Wolff et al, 2020^Citation459 [intradiscal cBMA]	Retrospective analysis	33	VAS, ODI, SF-36	Intradiscal cBMA injections may be effective to reduce pain and improve function. Patients with relatively higher initial pain may have potential for greatest improvement.	Level I-C
Amirdelfan et al, 2021^Citation460 [MPCs]	Multicenter, randomized, controlled study	100	VAS, ODI, SF-36, Radiographs, Productivity and Activity Index	Results provide evidence that intradiscal injection of MPCs could be a safe, effective, durable, and minimally invasive therapy for subjects with chronic LBP associated with moderate degenerative disc disease. There were no significantly increased rates of adverse events in the MPC groups compared to control groups up to 36 months post injection of intradiscal MPCs.	Level I-B
Haufe et al, 2006^Citation461 [HSCs]	Prospective case report	10	VAS	Even though MSCs have been suggested as a possible treatment for degenerative discs, this study reveals that HSCs, which are similar precursor cells, are of no benefit in living human subjects. Possibly the HSCs cannot survive in the oxygen-poor environment of the disc, even with hyperbaric oxygen therapy.	Level I-B
Yin et al, 2014^Citation82 [Fibrin]	Prospective Multicenter Pilot Study	15	VAS, RMDQ	Intradiscal injection of fibrin appears safe and may improve pain and function in selected patients with discogenic pain. There were 2 instances of low back muscle spasm and one case of discitis were considered related to the procedure or product	Level I-B
Peng et al, 2010^Citation81 [methylene blue]	Randomized placebo-controlled trial	72	NRS, ODI	The current clinical trial indicates that the inj. of methylene blue into the painful disc is a safe, effective and minimally invasive method for the treatment of intractable and incapacitating discogenic LBP.	Level I-B
Beall et al, 2021^Citation80 [viable disc allograft]	Prospective, multicenter, blind, randomized clinical trial	182	VASPI, ODI	Viable disc allograft injection into painful degenerated discs demonstrated improvements in pain and function scores, with excellent safety profile.	Level I-B

Abbreviations: NRS, numeric rating scale; AF, annulus fibrosus; NP, nucleus pulposus; IVD, intervertebral disc; PRP, platelet-rich plasma; VAS, visual analog scale; ODI, Oswestry Disability Index; LBP, low back pain; NASS, North American Spine Society; FRI, Functional Rating Index; MSCs, mesenchymal stem cells; RCT, randomized controlled trial; SF-36, short form 36 questionnaire; DDD, degenerative disc disease; MRI, magnetic resonance imaging; BMC, bone marrow concentrate; SANE, single assessment numeric evaluation; MPC, mesenchymal precursor cell; HA, hyaluronic acid; SVF, stromal vascular fraction; HSC, hematopoietic stem cells; RMDQ, Roland-Morris Disability Questionnaire; VASPI, visual analog scale of pain intensity.

Table 10 ASPN Back Consensus Group Recommendations for Regenerative Therapies

Recommendation	Grade	Level	Level of certainty
			Net benefit
Intradiscal PRP in the treatment of discogenic LBP	I	I-B	Low
Intradiscal allogeneic mesenchymal stem cells in the treatment of discogenic LBP	I	I-B	Low
Intradiscal bone marrow derived MSCs	I	I-B	Low
Intradiscal adipose tissue derived MSCs	I	I-C	Low

Note: While these small moderate quality studies look promising, there is much yet to do in this space.

Abbreviations: LBP, low back pain; MSCs, mesenchymal stem cells.

Table 11 Evidence Summary for Sacroiliac Joint Injections

Study author	Study type	Study size	End point	Evidence level	Notes
Maugars et al, 1996^Citation130	Prospective RCT double blind saline vs steroid for SIJ	10	NRS, NSAID use, pain relief at 1 month	I-A	Comparing VAS decrease in steroid injections 6.8 to 1.3 to saline 7.0 to 5.2, decrease in NSAID use in steroid injections (50%) vs saline (14%) injections and pain relief at 1 month, saline 1/7 and steroid 5/6.
Kim et al, 2010^Citation131	Prospective RCT comparing prolotherapy vs SIJ injection	48	>50% pain relief in two groups and sustained pain relief at 15 mo	I-A	>50% improvement: SIJ steroid group: 27.2%, prolotherapy: 63.6%. pain relief at 15 months: SIJ steroid: 10.2%, prolotherapy: 58.7%
Jee et al, 2014^Citation115	Prospective observational: IA injection fluoroscopic vs ultrasound guidance	110	VAS decrease at 2 weeks and 12 weeks	I-B	Intra-articular injection with fluoroscopic vs ultrasound guidance, effectiveness data also collected with mean pain (NRS) decrease at 2 weeks, 6.45 to 3.14 (51.3% reduction) and 6.45 to 2.56 at 12 weeks
Liliang et al, 2011^Citation123	Prospective observational	58	>50% pain relief at 6 weeks	I-B	Used dual + blocks as selection criteria for therapeutic injection. Amount of patients who underwent SIJ injection with steroid and local anesthetic and assessed who had >50% pain relief at 6 months, 67%
Chou et al, 2004^Citation111	Retrospective	54	Percent of patients with 80% at 2 weeks	I-C	Used dual + blocks as selection criteria for therapeutic injection. Pain relief of >80% at 6 weeks was found to be 28% (95% CI: 16–40%)
Irwin et al, 2007^Citation462	Retrospective	42	>50% pain relief at 1 month	I-C	Used dual + blocks as selection criteria for therapeutic injection. Pain relief of >50% at 1 month found in 43% of patients (18/42)
Hawkins et al, 2009^Citation463	Retrospective	120	Significant pain relief of 50% or more	I-C	77% of patients with >50% pan relief at 3, 6, 12 months
Borowsky et al, 2008^Citation464	Retrospective	120	Change in VAS pain scores and patient self- reported ADLs at 3 weeks and 3 months	I-C	12.5% for intra-articular SIJ injection versus 31.25% for combined intra-articular and peri-articular injection at 3 months
Maugars et al, 1992^Citation465	Prospective	42	% improvement maintained 1 month	I-B	Diagnosis of sacroiliitis with a sero-negative spondyloarthropathy, % improvement maintained for at least 1 month: 100% improvement: 26.2%, 80–90% improvement: 40.5%, 70–80% improvement: 14.3%, 50–70% improvement: 4.8%.
Visser et al, 2013^Citation466	Prospective	18	Patients with pain relief (>NRS 2/10 decrease) 12 weeks compared to baseline	I-B	Pain relief of at least VAS decrease 2/10, at 12 weeks compared to baseline: 50% (95% CI: 27–73%) of patients

Abbreviations: RCT, randomized controlled trial; SIJ, sacroiliac joint; NRS, numeric rating scale; NSAID, non-steroidal anti-inflammatory drug; VAS, visual analog scale; 95% CI, 95% confidence interval; ADLs, activities of daily living.

Table 12 ASPN Back Consensus Group Recommendations for Sacroiliac Joint Injections

Recommendation	Grade	Level	Level of certainty
			Net benefit
Sacroiliac joint injections have been associated with positive predictive value in diagnosis of SIJ dysfunction	A	I-A	Strong
Sacroiliac joint injections demonstrate short term relief of SIJ dysfunction	B	I-B	Moderate

Table 13 Evidence Summary for PILD in Spinal Stenosis

Study	Study type	Study size	Endpoints	Results	Evidence
Chopko et al, 2010^Citation141 MIDAS I	Prospective clinical study	N=78 Outcomes assessed at baseline and 6 weeks	VAS, ODI, ZCQ, SF-12 Health Survey.	At Baseline- VAS =7.3(3–10) ODI =47.4(16–84) At 6-week follow-up VAS = 3.7(0–10) (p<0.0001) ODI= 29.5 (0–72) (p<0.0001) ZCQ- Patients had statistically significant improvement in both pain and neuroischemic domain at 6-week follow-up. (p<0.001) Health of the patients showed statistically significant (95% CI) improvement in SF-12v2 survey for all but the general health survey scale.	I-C
Basu et al, 2011^Citation467	Prospective case series	N=27 Patient outcomes assessed at baseline and 6 months	VAS, ODI, ZCQ	Baseline- VAS = 9.1(95% CI ± 0.59) ODI =55.1 (95% CI ± 6.34) At 6 months- VAS = 3.9 (95% CI ± 2.25) (p<0.0001) ODI=31.1 (95% CI ± 9.29) (p<0.0004) ZCQ showed significant improvement in both pain and neuroischemic domains. No device/procedure related complications were reported.	I-C
Deer et al, 2012^Citation468	Prospective clinical study	N=46 Outcomes assessed at baseline, 12 weeks, 6 months, and 12 months	VAS, ODI, ZCQ	At Baseline - VAS = 6.9 (95% CI ± 0.6) ODI = 49.4 (95% CI ± 2.5) At 12 weeks- VAS = 4.2 (95% CI ± 1.0) (p<0.01) ODI= 35.1 (95% CI ± 5.6) (p<0.01) At 6 months- VAS= 4.4 (95% CI ± 1.0) (p<0.01) ODI= 35.0 (95% CI ± 5.5) (p<0.01) At 12-month follow-up- VAS=4.0 (95% CI ± 1.0) (p < 0.0001) ODI=32.0 (95% CI ± 5.8) (p < 0.0001) Statistically significant improvements were achieved in all ZCQ domains, including Symptom Severity, both Symptom Severity sub-domains (Pain and Neuro-Ischemic) and Physical Function (paired t-test; P < 0.0001).	I-B
Brown et al, 2012^Citation469	Prospective randomized clinical trial	N=38 Outcomes assessed at baseline, 6 and 12 weeks	VAS, ODI, ZCQ	In the PILD treatment group: At Baseline- VAS = 6.3 (95% CI ± 0.7), ODI = 38.8 (95% CI ± 4.2) At 6 weeks- VAS=3.8 (95% CI ± 1.3) ODI=27.4 (95% CI ± 7.0) At 12 weeks- VAS= 3.4 ODI=18.6 The change in VAS from baseline to week 6 and baseline to week 12 was significant (p< 0.01), but the change from week 6 to week 12 was not significant. The change from baseline to 6-weeks post PILD and baseline to 12-weeks post PILD was significant (p < 0.05), but the change from 6-weeks to 12-weeks was not significant, (p>0.05). In the ESI treatment group- At Baseline- VAS = 6.4 (95% CI ± 1.0) ODI = 40.5 (95% CI ± 5.9) At 6 weeks- VAS= 6.3 (95% CI± 1.4) (p > 0.05). ODI =34.8 (95% CI ± 8.2) (p>0.05) ZCQ score showed significant improvement at 6 and 12 weeks for PILD treatment group.	I-A
Mekhail et al, 2012^Citation133	Prospective case series study	N=40 Outcomes assessed at baseline and 1 year.	PDI, RMQ	At Baseline Mean PDI score = 41.4 (95% CI ± 4.6) Mean RMQ= 14.3 (95% CI ± 2.1) VAS= 7.1(95% CI ± 0.8) At 1 year Mean PDI= 18.8 (95% CI ± 4.9) (p<0.0001) Mean RMQ= 6.6 (95% CI ± 2.0) (p<0.0001) VAS= 3.6 (95% CI ± 0.9) (p<0.0001) Standing Time improved from a baseline of 8 to 56 minutes at 12-month follow-up. (ANOVA, p<0.00001) Walking Distance improved from a baseline mean of 246 feet to 3956 feet at 12-month follow-up. (ANOVA, p<0.00001)	I-B
Benyamin et al, 2016^Citation142 MiDAS ENCORE I	Prospective, multicenter, RCT	N=302 Outcomes assessed at baseline, 6 months, and 1 year	ODI, NPRS, ZCQ	At 6 months responder rate- ODI PILD vs ESI = 62.2% vs 35.7% (95% CI ± 26.6%) (p<0.001) NPRS PILD vs ESI = 55.9% vs 33.3% (95% CI ± 22.6%) (p<0.001) At 1 year- ODI PILD vs ESI = 58% vs 27.1% (95% CI ± 30.9%) (p<0.001) NPRS PILD vs ESI = 57.3% vs 27.1% (95% CI ± 30.2%) (p<0.001) Statistically significant improvements were seen with PILD over ESI in all three domains of ZCQ at 6 months and 1 year. (p<0.001).	I-B
Staats et al, 2018^Citation470 MiDAS ENCORE II	2-year follow-up data for PILD procedure arm of MiDAS ENCORE study	N=143 6-months, 1 year and 2 years	ODI, NPRS, ZCQ	At 2 years- ODI improved by 22.7 points (95% CI, 18.5–26.9), NPRS improved by 3.6 points (95% CI, 3.1–4.2), and ZCQ symptom severity and physical function domains improved by 1.0 (95% CI, 0.8–1.2) and 0.8 points (95% CI, 0.6–0.9), respectively. Improvements in all domains were statistically significant. There were no serious device related adverse events	I-A
Deer et al, 2022^Citation19 The MOTION study	Prospective, multicenter, randomized controlled clinical study	N=155 Patients evaluated at baseline, 6 months, and 1 year	ODI, NPRS, ZCQ	At Baseline- CMM alone vs PILD+ CMM ODI= 51.7 ± 14.8 vs 55.3 ± 14.3 (p=0.129) NPRS= 7.8 ± 1.5 vs 7.5 ± 1.4 (p=0.259) ZCQ Symptom Severity= 3.56 ± 0.59 Vs 3.58 ± 0.61 (p= 0.887) ZCQ Physical Function = 2.78 ± 0.46 Vs 2.84 ± 0.50 (0.425) At 6 months- outcome measures with mean improvement ± SD CMM alone vs PILD+ CMM ODI= 3.8 ± 11.1 vs 16.3 ± 18.0 (p<0.001) NPRS Back= 0.6 ± 1.7 vs 2.4 ± 2.6 (p<0.001) NPRS Leg= 0.9 ± 2.0 vs 2.5 ± 3.0 (p<0.001) ZCQ Symptom Severity= 0.11 ± 0.48 Vs 0.72 ± 0.85 (p= <0.001) ZCQ Physical Function = 0.05 ± 0.35 Vs 0.48 ± 0.65(p<0.001) At 1 year- outcome measures with mean improvement ± SD CMM alone vs PILD+ CMM ODI= 2.0 ± 11.7 vs 16.1 ± 19.0 (p<0.001) NPRS Back= 0.4 ± 1.3 vs 1.4 ± 2.1 (p<0.001) NPRS Leg= 1.4 ± 2.1 vs 3.6 ± 3.1 (p<0.001) ZCQ Symptom Severity= 0.12 ± 0.46 Vs 0.64 ± 0.83 (p= <0.001) ZCQ Physical Function = 0.04 ± 0.38 Vs 0.43 ± 0.70 (p<0.001) PILD with CMM was superior to CMM alone across all measures in treating patients with neurogenic claudication.	I-A

Abbreviations: ZCQ, Zurich Claudication Questionnaire; ESI, epidural steroid injection; VAS, visual analog scale; ODI, Oswestry Disability Index; SF-12, Short Form Health Questionnaire; 95% CI, 95% confidence interval; PDI, Pain Disability Index; PILD, percutaneous image-guided minimally invasive lumbar decompression; RMQ, Roland-Morris Disability Questionnaire; ANOVA, analysis of variance; NPRS, numeric pain rating scale; CMM, conventional medical management.

Table 14 ASPN Back Consensus Group Recommendations for PILD Injections

Recommendation	Grade	Level	Level of certainty
			Net benefit
Percutaneous lumbar decompression for ligamentum flavum hypertrophy with the diagnosis of lumbar spinal stenosis	A	I-A	Strong

Table 15 Evidence Summary for Interspinous Spacers, Indirect Decompression

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Nunley et al, 2018^Citation471	Post hoc analysis of RCT	190	I-B	Opioid Use	Opioid use: -50% at baseline after procedure -25.2% at 12 months -13.3% at 24 months -7.5% at 60 months.
Nunley et al, 2018^Citation472	Post hoc analysis of RCT	190	I-B	SF-12	-Physical Component Summary (PCS) score: 29.4 ± 8.1 Pre- operative to 43.8 ± 11.6 at 5 years (49%). -Mental Component Summary (MCS) score: from 50.0 ± 12.7 Pre-operative to 54.7 ± 8.6 at 5 years -Improved Quality of Life at 60 months
Nunley et al, 2017^Citation473	Open-label follow-up study on RCT treatment arm	88	I-B	ODI, VAS, ZCQ	-65% of patients demonstrated success in ODI -80% of patients showed successful improvements in VAS -84% of patients demonstrated clinical success in at least 2 of 3 ZCQ domains
Patel VV et al, 2015^Citation152	Multicenter, RCT	391	I-A	ODI, VAS, ZCQ	-63% patients improved ODI -76% patients improved leg pain -65% patients improved back pain -84% of patients demonstrated clinical success in at least 2 of 3 ZCQ domains
Bini W et al, 2011^Citation474	Prospective, single-arm	104	I-B	NRS, ODI, SF-12	-86% improvement in extremity pain -76% improvement in LBP -64% improvement in ODI -41% improvement in PCS -22% improvement in MCS
Shabat S et al, 2011^Citation475	Prospective, single arm	53	I-B	NRS, ZCQ, ODI, SF-12	-54% improvement in axial and extremity pain -43% improvement in ZCQ(ss) -44% improvement in ZCQ(pf) 75% of patients had clinically successful improvements in ODI (defined as a 30% improvement in score) -40% improvement in PCS and MCS

Abbreviations: RCT, randomized controlled trial; PCS, physical component summary; MCS, mental component summary; ODI, Oswestry Disability Index; VAS, visual analog scale; ZCQ, Zurich Claudication Questionnaire; NRS, numeric rating scale; SF-12, Short Form Health Questionnaire; LBP, low back pain.

Table 16 ASPN Back Consensus Group Recommendations for Interspinous Spacers, Indirect Decompression

Recommendation	Grade	Level	Level of certainty
			Net benefit
Stand-alone interspinous spacers for indirect decompression are safe and effective for the treatment of mild to moderate lumbar spinal stenosis if no contraindications exist	A	I-A	High

Table 17 Evidence Summary for Percutaneous and Endoscopic Procedures

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Teli et al, 2010^Citation170	Prospective, randomized, single center	212	I-A	VAS (leg and back), ODI, SF-36 (mental and physical health)	No difference in VAS, ODI or SF-36 scores throughout follow up between groups, all improved significantly within groups
Garg et al, 2011^Citation171	Prospective, randomized, single center	112	I-B	ODI	Mean ODI change of 12.76 in MED, 6.97 in OD at 1 week, Continued improvement over 12 months but not statistically significant in either group
Hussein et al, 2014^Citation172	Prospective, randomized, single center	185	I-B	NRS (leg and back), ODI	Mean NRS leg change 7.8 (MED) v. 6.6 (OD), Mean NRS back change 1.9 (MED) v. 4.4 (OD), Mean ODI change 51.2% (MED) v. 11.17% (OD), McNabb’s criteria Excellent outcome 92.6% (MED) v. 42.2% (OD), Good outcome 4.2% (MED) v. 28.9% (OD), Fair outcome 1.1% (MED) v. 24.4% (OD), Poor outcome 2.1% (MED) v. 4.4% (OD)
Chen et al, 2018^Citation173	Prospective, randomized, single center	153	I-A	VAS (leg and back), ODI, SF-36 (mental and physical health)	No difference in ODI, VAS or SF-36 scores between groups, significantly improved from preoperative in both groups
Ruetten et al, 2008^Citation174	Prospective, randomized, single center	200	I-A	VAS (leg and back), ODI, NASS	VAS, ODI and NASS significantly decreased from preoperative to postoperative, No difference between the two groups, 2 years 79% v 89% with no leg pain
Pan et al, 2014^Citation175	Prospective, randomized, single center	20	I-B	VAS	VAS improved in both groups with no statistical difference between groups (OD 7.5 to 1.9, PELD 7.5 to 1.8); Blood loss (99 v. 8), hospital stay (5.6 v. 1.9) and wound size (4.9 v. 0.51) significantly less in PELD group
Pan et al, 2016^Citation179	Prospective, randomized, single center	106	I-B	VAS, JOA and ODI	VAS scores statistically significantly better at all time points up to 12 months (p < 0.05), no difference noted between groups at 12 months; JOA and ODI with no difference throughout; incision size (0.8 v. 3.7), blood loss (13.8 v 87.2), hospital stay (7.2 v 12.8) significantly better in PELD (p < 0.05)
Ding et al, 2017^Citation176	Prospective, randomized, single center	100	I-B	VAS and ODI	VAS and ODI decreased in each group pre to post op but no difference between the groups; Incision length (3 v. 0.5) and hospital stay (10.2 v. 7.6) significantly decreased in PELD
Ryang et al, 2008^Citation177	Prospective, randomized, single center	60	I-B	VAS, ODI, SF-36	VAS and ODI decreased in each group but no statistical difference between groups at postop (2.1 v. 2.1, 12 v 12), SF-36 improved in both (no difference in physical score (47.5 v 47.6), improved mental score in OD (51.9 v 44)), no difference in operative time, blood loss or hospital stay
Franke et al, 2009^Citation178	Prospective, randomized, multicenter	100	I-A	VAS, ODI	VAS and ODI improved in both groups and both centers but no difference between the groups
Arts et al, 2011^Citation476	Prospective, randomized, multicenter	325	I-A	VAS, RDQ	VAS leg, VAS back and RDQ similar between two groups

Abbreviations: VAS, visual analog scale; ODI, Oswestry Disability Index; SF-36, Short Form Health Questionnaire; MED, microendoscopic discectomy; NRS, numeric rating scale; OD, open discectomy; NASS, North American Spine Society questionnaire; PELD, percutaneous endoscopic lumbar discectomy; JOA, Japanese Orthopedic Association; RDQ, Roland-Morris Disability Questionnaire.

Table 18 ASPN Back Consensus Group Recommendations for Percutaneous and Endoscopic Procedures

Recommendation	Grade	Level of evidence	Level of certainty
			Net benefit
Microendoscopic Discectomy	B	I-a	High
Percutaneous Endoscopic Discectomy	B	I-a	High
Tubular Discectomy	B	I-a	High

Table 19 Evidence Summary for Interspinous/Interlaminar Fusion Devices

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Postacchini et al, 2016^Citation195	Prospective cohort, multicenter	25	I-B	Rates of Fusion, NRS (leg and back), ODI, SF-36 (mental and physical health)	Provided fusion and highly significant improvement in all outcome measures at a two-year follow-up
Schmidt et al, 2018^Citation196	Prospective, randomized, multi center	230	I-A	ODI	Primary endpoint being superior for the ISF with decompression group, as well as patients in the decompression alone group being more likely to undergo a secondary intervention or injections
Musacchio et al, 2016^Citation197	Prospective, randomized, multi center	215	I-A	ODI	ISF with decompression group had 50.3% of the patients meeting all composite endpoints, while it was at 44% in the pedicle screw fusion group. The two groups were similar in reoperation rates, as well as improvement in ODI, and VAS
Chin et al, 2020^Citation198	Retrospective review of prospective data	56	III	VAS (leg and back), ODI	There were significant improvements in both VAS pain scores, as well as ODI

Abbreviations: NRS, numeric rating scale; ODI, Oswestry Disability Index; SF-36, Short Form Health Questionnaire; ISF, interspinous fixation; VAS, visual analog scale.

Table 20 ASPN Back Consensus Group Recommendations for Interspinous/Interlaminar Fusion Devices

Recommendation	Grade	Level	Level of certainty
			Net benefit
ISF can be used as a stand- alone device for decompression.	B	I-B	Moderate
ISF can be used as a stand- alone device for spinal fusion	C	I-B	Moderate
ISF is a suitable option to those patients not suited for pedicle screw fixation, non- surgical candidates, and those early in the treatment paradigm	B	I-B	Moderate

Table 21 Evidence Summary for Minimally Invasive Sacroiliac Fusion

Source, year	Design	Study size	Endpoints	Notes	Level of evidence
Endres et al, 2013^Citation477	Case series	19	ODI, VAS	VAS reduction from 8.5 at baseline to 6 (2 points, 29.4% pain reduction). Mean ODI score decreased from 64.1 at baseline to 57 at follow-up. Fusion was seen in 79% of joints.	II
Fuchs and Ruhl, 2018^Citation220	Retrospective observational study	171	VAS, ODI, SF-12, SF-MPQ	ODI improved from 51 to 33, the SF-MPQ decreased from 50% to 31%, the SF-12 physical component rose from 22% to 41%, the mental component summary increased from 40% to 55%, and VAS decreased from 74 to 37 mm.	I-C
Wise and Dall, 2008^Citation478	Case Series	13	VAS	Improvements were seen in the LBP score on a VAS, with an average improvement of 4.9 cm. Leg pain improved an average of 2.4 cm, and dyspareunia pain improved an average of 2.6 cm. The overall fusion rate was 89% (17 of 19 joints) as assessed by postoperative CT scan obtained 6 months after the procedure.	II
Rajpal et al, 2019^Citation219	Retrospective observational study	24	NRS, self-reported patient satisfaction	Statistically significant reduction in LBP scores from an average baseline score of 6.6 to 3.7 postoperatively. Leg pain scores decreased from 4.8 to 1.5. The mean total satisfaction score was 79.0%.	I-C
Patterson et al, 2018^Citation479	Case series	21	NRS, activity level and overall satisfaction	NRS reduction at 12 weeks was 6.29. 73.2% avg pain reduction at 10–12 weeks. 81.8% patients reported at least 60% reduction in pain. Overall satisfaction with procedure was an average of 4.95 (0–5 scale).	II
Mann et al, 2019^Citation480	Case series	10	NRS, activity level and overall satisfaction	NRS reduction was 4.6 (62.3% avg pain reduction) at 12 weeks. NRS reduction was 6.1 (79.2% avg pain reduction) at 12 months. 80% patients reported at least 60% reduction in pain with 7 of those patients having complete resolution of pain at 12 months.	II
Pyles et al, 2020^Citation481	Case series	7	NRS, % pain relief	Average NRS was 6.9 pre-fusion, 0.8 post-fusion, and 0.4 at most recent follow-up (average NRS reduction of 6.5, 94.2% pain reduction).	II
Pyles 2019^Citation482	Case series	20	% pain relief	SIJF in previous SCS implanted patients. 55% of the patients (11/20) received 100% pain relief with the average percentage improvement of pain being 72% at less than 6 months follow-up.	II
Kim et al, 2019^Citation483	Case series	16	Opioid use, NRS, % pain relief	Average pre-fusion NRS was 7.15 ± 1.76 and average post-fusion NRS at latest follow-up was 0.90 + 1.97. Mean decrease of 5.9 cm in NRS (88% pain reduction). Average improvement following fusion was 89.50%.	II
Calodney et al, 2022^Citation222	Prospective, Multicenter	69	VAS, ODI, PROMIS 29, adverse events	Average mean improvement in VAS of 34.9, ODI reduction of 17.7 and 0 device related adverse events.	I-B
Lam et al, 2020^Citation484	Retrospective observational study	75	% pain relief, opioid use	Average percent relief at 3 months follow-up was 83.3%. Twelve out of the 45 patients (26.7%) reported decreased opioid use. 30 patients (43.5%) reported near complete resolution at 3 months.	I-C
Sayed et al, 2021^Citation218	Retrospective observational study	50	NRS, % pain relief	The overall average pre SIJ fusion NRS was 6.98 (95% CI [6.26, 7.70]). The overall average NRS at last follow up was 3.06 (95% CI [2.35, 3.77]) with an average overall percent relief of 66.5%. Sub-analysis conducted for those patients with and without history of lumbar fusion.	I-C
Deer et al, 2021^Citation221	Retrospective observational study	111	% pain relief	At the last follow-up, the mean overall patient reported pain relief was 67.6% ± 28.9%. One hundred and two patients (91.9%) reported pain relief post-operatively of ≥30%. Fifty-two patients (46.8%) had a patient reported pain relief of ≥80%	I-C
Duhon et al^Citation205	Prospective observational study	172	VAS, ODI	VAS decreased from 79.8 to 26.0 at 24 months (p<0.001) and ODI decreased from 55.2 to 30.9 (p<0.001). Percent of patients taking opioids decreased from 76.2% to 55%.	I-B
Darr et al^Citation485	Prospective observational study	103	VAS, ODI, EQ-5D	Mean improvement in SI joint pain of 55 points (0–100), mean improvement in ODI of 28 points, improvement in EuroQOL-5D of 0.3 points (p<0.0001).	I-B
Polly et al^Citation224	RCT	102 surgery, 46 conservative	VAS, ODI, EQ-5D, SF-36	At 24 months, 82% of SI joint fusion group received substantial clinical benefit in VAS and 66% received substantial clinical benefit in ODI score.	I-A
Dengler et al^Citation203	RCT	52 surgery, 51 conservative	VAS, ODI, ASLR, EQ-5D-3L, walking distance, satisfaction	Mean LBP improved in the SI joint fusion group by 43.3 points vs.5.7 points in conservative group (p<0.0001). Mean ODI improved by 26 points in surgical group vs 6 points in nonsurgical group (p<0.0001).	I-A
Araghi et al^Citation228	Prospective observational study	50	VAS, ODI, opioid use	SI joint pain decreased from 76.2 to 35.1 (p<0.0001) and ODI decreased from 55.5 to 35.3 (p<0.001). Opioid use was reduced from 66 to 30%.	I-B
Al-Khayer et al^Citation486	Case Series	9	VAS, ODI	Mean ODI decreased from 59 to 45 (p<or+0.005) and mean VAS was reduced from 8.1 to 4.6 (p<or=0.002). Mean patient satisfaction 6.8	II
Khurana et al^Citation487	Case Series	15	SF-36, Majeed scoring system	Mean SF-36 improved from 37 to 80 for physical function and 53 to 86 for general health (p=0.037) and mean Majeed score increase from 37 to 79 (p=0.014).	II
Mason et al^Citation229	Prospective observational study	55	VAS, SF-36, Majeed scoring system	VAS SI joint pain improved from 8 to 4.5, SF-36 improved from 26.6 to 42.9, Majeed score increased from 36.9 to 64.8.	I-B
Rappoport et al^Citation227	Prospective observational study	32	VAS, ODI	Mean VAS back and leg pain scores decreased significantly by 12 months postop (p<0.01).	I-B
Patel et al^Citation488	Prospective observational study	51	ODI, SI joint pain score	ODI decreased from 52.8 to 27.9 (p<0.001) and SI joint pain score improved from 78 to 21 (p<0.0001). Proportion of subjects taking opioids decreased from 57% to 22% and 3 physical function tests improved	I-B

Abbreviations: ODI, Oswestry Disability Index; VAS, visual analog scale; SF-12, Short Form Health Questionnaire; MPQ, McGill Pain Questionnaire; LBP, low back pain; CT, computed tomography; NRS, numeric rating scale; SIJF, sacroiliac joint fusion; SCS, spinal cord stimulation; ASLR, active straight leg raise; EQ-5D, EuroQOL Health Questionnaire.

Table 22 ASPN Back Consensus Group Recommendations for Minimally Invasive Sacroiliac Joint Fixation

Recommendation	Grade	Level	Level of certainty Net benefit
Minimally Invasive Sacroiliac Fusion	A	I-A	High

Table 23 Evidence Summary for Vertebral Augmentation

Source, year	Design	Sample size	Treatment arms	Level of evidence	Follow-up	Outcome measures	Results	Complications
Wang et al, 2021^Citation489	RCT	72	Bilateral percutaneous kyphoplasty (PKP) vs percutaneous curved kyphoplasty (PCKP)	I-A	6 months	Fluoroscopy time, total surgical time, cement volume, anterior vertebral height, Cobb angle, VAS, and ODI	VAS and ODI at 24 hours and 6 months: Improvement in both groups without statistical significance Total Surgical and Fluoroscopy Times: PCKP group had significantly lower times than PKP (p<0.05) Cement Volume: Higher cement perfusion volume in the PKP group (4.78±0.67mL) compared to PCKP (3.84±0.55mL) Vertebral Height: Both groups produced an increase in height without a statistical significant difference. Cobb Angle: Both groups resulted in decreased Cobb angle without a statistical significant difference	Bone Leakage: 3 in PCKP and 8 in PKP
Griffoni et al, 2020^Citation271	Prospective, RCT	139	Percutaneous vertebroplasty vs Balloon kyphoplasty	I-A	12 months	VAS, WHOQoL, ODI, imaging indices	VAS: Reduced VAS scores in both groups. No statistically significant difference. ODI: Significantly reduced scores in both groups but no statistically significant difference between them. WHOQoL5D: Scores significantly increased in both groups without statistical difference between them. Imaging Indices: No statistical difference between either group in regard to wedge angle reduction or sagittal index.	Rate of cement leakage 4.5% 40 new fractures reported during follow-up in 113 patients. 12 were at adjacent level
Noriega et al, 2020^Citation490	Prospective, parallel group, controlled comparative randomized study	152	Titanium implantable vertebral augmentation device vs balloon kyphoplasty (BKP)	I-A	12 months	Responder rate VAS, ODI, EQ-5D	Responder Rates for Primary Composite: TIVAD - 89.8% (95% CI 82.1%-97.5%) BKP - 87.3% (95% CI 78.5%-96.1%) Bayesian Analysis of Primary Composite: TIVAD non-inferior to BKP 1 year after surgery VAS and EQ-5D: Sustained improvement over all time points favoring TIVAD ODI: Progressive improvement between both groups	Lumbar and thoracic vertebral fractures in both groups Non-serious rib fracture in TIVAD group
Beall et al, 2019^Citation260	Prospective, clinical trial, multicenter	350	Balloon kyphoplasty	I-B	12 months	NRS, ODI, SF-36v2 PCS, EQ-5D,	Statistically significant improvement at 3 months: NRS – improved 6 points (p<0.001) ODI – improved 35.3 points (p<0.001) SF-36v2 PCS – improved 12.4 points (p<0.001) EQ-5D – improved 0.351 points (p<0.001) Statistically significant improvement noted at all time points	1 asymptomatic balloon rupture 1 subject with rib pain beginning intraoperatively ending <6 months 1 new adjacent VCF at 25 days postoperatively 1 aspiration pneumonia with prolonged hospital stay 1 myocardial infarction at 105 days postoperatively
Liu et al, 2019^Citation491	RCT	100	Percutaneous kyphoplasty vs Percutaneous vertebroplasty	I-A	1 month	BGP, B-CTX, BALP, TRACP, malondialdehyde (MDA), total antioxidant capacity (TAC), superoxide dismutase (SOD), VAS scores, ODI values, Cobb’s angle	Bone Markers: BGP higher in observation group B-CTX, BALP, and TRACP lower in observation group MDA lower in observation group TAC and SOD higher in observation group ODI and VAS: No significant difference Cobb’s angle: Smaller angle in observation group	None reported
Lui et al, 2019^Citation492	RCT	116	Balloon kyphoplasty vs Conservative Therapy	I-A	NR	Percentage of trailing, leading, and midcourt height Degree of upper thoracic kyphosis VAS and Barthel Index	Trailing Edge (%) Observation: 10.14±3.19 Control: 1.84±0.67 Leading Edge (%) Observation: 15.13±4.21 Control: 0.74±0.47 Midcourt Line Height (%) Observation: 14.72±3.25 Control:1.73±0.53 Upper Thoracic Kyphosis(°) Observation: 13.17±2.67 Control:1.69±0.83 VAS (after treatment) Observation: 2.25±0.21 Control: 4.54±0.28 Barthel Index Observation: 24.34±4.53 Control: 31.57±4.25	Observation Group: 1 case of cement leakage Rate of complication of 1.72% Control Group: 1 case of venous embolism 4 cases of decubitus ulcers 4 cases of infection Rate of complication was 15.52% Observation had significantly lower rates of complications (p<0.05)
Firanescu et al, 2018^Citation493	RCT	180	Vertebroplasty vs sham control	I-A	12 months	VAS, QUALEFFO, RMDQ	Mean VAS reduction at 12 months): Vertebroplasty: 5.00 (95% CI 4.31–5.70) Sham: 4.75 (95% CI 3.93–5.57) Group Difference: 0.13(95% CI −0.41 to 0.66) Mean QUALEFFO reduction at 12 months: Vertebroplasty: 18.32 (95% CI 18.32 to 23.61) Sham: 18.61 (95% CI 13.02 to 24.2) Group Difference: −0.14 (95% CI −3.04 to 2.76) Mean RMDQ reduction at 12 months: Vertebroplasty: 7.71 (95% CI 5.87 to 9.55) Sham: 7.47 (95% CI 5.56 to 9.38) Group Difference: 0.12 (95% CI −1.11 to 1.35)	1 patient with chronic pulmonary obstructive disease developed respiratory insufficiency 1 patient had a vasovagal reaction
Hansen et al, 2016^Citation494	Double blind, placebo-controlled, RCT	46	Percutaneous vertebroplasty vs Sham	I-A	12 months	VAS, SF-36 PCS, SF-36 MCS, EQ-5D	Mean VAS (standard error) at 12 months: PVP: 28.35 (5.16) Sham: 30.67 (4.65) No statistical difference between groups Mean SF-36 PCS (standard error) at 12 months): PVP: 31.90 (9.19) Sham: 35.15 (11.92) No statistical difference between groups Mean SF-36 MCS (standard error) at 12 months: PVP: 48.60 (10.75) Sham: 53.60 (10.29) No statistical difference between groups Mean EQ-5D (standard error) at 12 months: PVP: 0.67 (0.27) Sham: 0.74 (0.22) No statistical difference between groups	NR
Clark et al, 2016^Citation251	Randomized, double-blind, placebo-controlled RCT, multicenter	120	Vertebroplasty vs Placebo	I-A	6 months	NRS, RMDQ, VAS, QUALEFFO, EQ-5D	NRS: Mean reduction ratio for vertebroplasty to placebo 1.3 (95% CI 0–2.6, p=0.043) VAS: Lower score with vertebroplasty at 14 days but not at 6 months (11, 95% CI 0–23, p=0.050) RMDQ: Mean reduction greater in vertebroplasty group. Maximum difference at 6 months of 4.2 (95% CI 1:6 to 6:9, p=0.0022) QUALEFFO: Lower in vertebroplasty group with mean difference at 6 months of 7 (95% CI 1–13, p=0.032) EQ-5D Higher score at 1 and 6 months (−0.06, 95% CI −0.10 to −0.01, p=0.012)	3 patients in each group died from unrelated causes Vertebroplasty Group: 1 respiratory arrest after sedation (resuscitated and underwent procedure 2 days later) 1 supracondylar humerus fracture during Placebo Group: 2 cases of spinal cord compression from interval collapse and retropulsion
Leali et al, 2016^Citation495	Prospective, multicenter, RCT	400	Percutaneous vertebroplasty vs conservative therapy	I-A	6 months	VAS, ODI, pain medication	Mean VAS: 2.3 points (post-op), 4.8 (pre-op), p=0.023 Mean ODI: 31.7% (post-op), 53.6% (pre-op), p⊆0.012 Analgesia: 120 (65%) able to stop analgesia after 48 hours (p⊆0.0001)	1 fracture of transverse process 1 psoas muscle bleed 3 patients had new vertebral fractures during follow up
Wang et al, 2016^Citation496	Prospective, RCT	206	Percutaneous vertebroplasty vs Image-guided facet joint blocks	I-A	12 months	VAS, ODI, RMDQ, SF-36 PCS, SF-36 MCS	Statistically significant lower VAS, ODI, and RMDQ in PVP group compared to FB group at 1 week (p<0.05). No statistical significance between groups for VAS, ODI, SF-36 at 12 months (p>0.05)	NA
Yang, et al, 2016^Citation497	Prospective, RCT	135	Percutaneous vertebroplasty vs conservative therapy	I-A	12 months	VAS, ODI, QUALEFFO	Statistically significant improvement for VAS, ODI, and QUALEFFO at 12 months (p<0.0001)	NA
Hartmann et al, 2015^Citation498	Retrospective Study	18	NA	II	NR	VAS, ODI, SF-36, Radiologic Evidence	ODI and SF-36 showed moderate limitations Restored vertebral kyphosis by 3.2° Restored segmental kyphosis by 5°	2 asymptomatic cement leakages
Tutton et al, 2015^Citation499	Prospective, randomized, non-inferiority study	300	Kiva vs Balloon Kyphoplasty	I-A	12 months	VAS, ODI, device related injuries	VAS Mean Improvement: Kiva: 70.8 points BK: 71.8 ODI Mean Improvement: Kiva: 38.1 BK: 42.2 Primary endpoint showed noninferiority of Kiva to BK	No serious adverse events
Chen et al, 2014^Citation500	RCT, comparative study	96	Percutaneous vertebroplasty vs conservative therapy	I-A	12 months	VAS, ODI, RMDQ	VAS, ODI, RMDQ significantly better at 12 months in PVP group (p⊆0.001) 39 PVP patients experienced complete pain relief compared to 15 CT patients (p⊆0.001)	NA
Diel et al, 2013^Citation501	Retrospective Review of RCT	100	NA	I-C	NR	Vertebral height, Beck Index, Alternate Beck Index, Local kyphotic angle,	Mean Post-Op Ant., Mid., and Post. Vertebral Height (mm): 24.5, 24.6, 30.4 Mean Post-Op Local Kyphotic Angle: Reduced to 8.9° Mean Post-Op Beck Index: 0.81 Mean Post-Op Alternative Beck Index: 0.82	NR
Korovessis et al, 2013^Citation502	Prospective RCT	190	BKP vs Kiva implantation	I-A	Average of 14 months (range of 13–15 months)	AVBHr, PVBHr, MVBHr, wedge angle, VAS, SF-36 (PF and MH), ODI	AVBHr % Correction: Kiva – 24.3±45 BKP – 23±63 PVBHr % Correction: Kiva – 5.92±16 BKP – −1.26±8 MVBHr % Correction: Kiva – 30.5±47 BKP – 21.9±26 Wedge Angle (°): Kiva – 5±3.5 BKP – 6±5 VAS: Kiva – 8.2±1.4 (Pre); 2.7±3 (Post) BKP – 7.8±1.2 (Pre); 2.5±3 (Post) SF-36 (%) improvement: Kiva – 51 (PF); 34 (MH) BKP – 59 (PF); 34 (MH) ODI: Kiva – 64±19 (Pre); 31.7±19 (Post) BKP – 62±14 (Pre); 26.3±15.7 (Post)	Cement leakage in 4 (0.03%) Kiva and 12 (0.098%) BKP. No intracanal leakage in Kiva. 2 (2.3%) intracanal leakage in BKP. 10 (12.2%) new fractures in Kiva and 11 (13%) in BKP
Otten et al, 2013^Citation503	Prospective comparison study	52	Balloon kyphoplasty vs Kiva	I-B	6 months	VAS, ODI	Kiva demonstrated greater pain improvement Kiva had less adjacent level fractures and cement leakage	NR
Werner et al, 2013^Citation504	RCT, comparative study	65	Balloon Kyphoplasty vs Vertebral Body Stenting	I-A	NR	Change in kyphotic angle	Change in Kyphotic Angle: BKP: 4.5±3.6 VBS: 4.7±4.2 p=0.972	9 cases of major cement leakage 10 intraoperative complications
Blasco et al, 2012^Citation505	Prospective, RCT	125	Vertebroplasty vs conservative therapy	I-A	12 months	VAS, QUALEFFO, analgesia, new fractures	VAS at 2 months: 42% mean reduction with PVP group compared to only 25% in CT group QUALEFFO: PVP group had significant improvement at all time points compared to CT only at 6 and 12 months Analgesia: No significant difference between two groups New Fractures: 2.78-fold more risk of new fracture in PVP group	NR
Vanni et al, 2012^Citation506	Prospective RCT	300	Balloon kyphoplasty vs SpineJack	I-A	12 months	VAS, ODI, radiographic evidence	VAS and ODI: No statistical difference between groups SpineJack had greater improvement in vertebral height compared to BKP	20 cement leakages in BKP group
Boonen et al, 2011^Citation264	RCT	232	Balloon kyphoplasty vs nonsurgical management	I-A	24 months	SF-36, EQ-5D, RMDQ, VAS, Likert Scale	SF-36: Significant improvement in pain (3.24 points, 95% CI 1.47–5.01, p = 0.0004) EQ-5D: Significant improvement in QoL (0.12 points, 95% CI 0.06–0.18, p = 0.0002) VAS: Significant reduction in back pain (−1.49 points, 95% CI −1.88 to −1.10, p<0.0001) RMDQ: -3.01-point difference in reduction of disability (95% CI −4.14 to −1.89, p<0.001) Likert Scale: Patients more satisfied (3.09 points, 95% CI 2.26–3.92, p<0.0001)	Similar frequency of adverse events and serious adverse events between two groups 1 hematoma at surgical site 1 recurrent UTI within 2 days of surgery. This patient also developed spondylitis 23 deaths (12 in observation group and 11 in control group) that were all unrelated to treatment
Farrokhi et al, 2011^Citation507	RCT, comparative study	105	Percutaneous vertebroplasty vs optimal medical therapy	I-A	36 months	VAS, ODI, radiologic evidence	VAS Mean Difference: -1.5 (−9.85 to 6.85, p<0.81) ODI Mean Difference: -14.0 (−14.91 to −13.09, p<0.01) Vertebral Height Mean Difference (cm): 2.0 (1.5 to 0.44, p<0.01) Sagittal Index Mean Difference (°): -14.0 (−14.96 to −13.05, p<0.011)	1 patient with epidural cement leakage
Muto et al, 2011^Citation508	Prospective Study	20	Vertebral body stenting system	II	12 months	VAS, ODS, radiological evaluation	Improved pain and disability scores. Improved vertebral body height: 1.5mm on average	No complications
Klazen et al, 2010^Citation509	RCT, multicenter, comparative	202	Vertebroplasty vs conservative treatment	I-A	12 months	VAS, EQ-5D, QUALEFFO, RMQD	VAS at 1 Month: Vertebroplasty – −5.2 (95% CI −5.88 to −4.72) Conservative – −2.7 (95% CI −3.22 to −1.98) Difference – 2.6 (95% CI 1.74–3.37, p<0.0001) VAS at 1 year: Vertebroplasty – −5.7(95% CI −6.22 to −4.98) Conservative – −3.7 (95% CI −4.35 to −3.05) Difference – 2.0 (95% CI 1.13–2.80, p<0.001) EQ-5D: 1 month - favored vertebroplasty with difference of 0.010 (95% CI 0.014–0.006) 1 year - favored vertebroplasty with difference of 0.108 (0.177–0.040) QUALEFFO and RMQD: Vertebroplasty had greater improvement (and quicker) over time	No serious complications or adverse events were reported
Rousing et al, 2010^Citation510	RCT	50	Percutaneous vertebroplasty vs Conservative therapy	I-A	12 months	VAS	VAS: 7.9 (Pre-Op) and 2.0 (Post-Op) for the PVP group. No statistical difference between groups at 3 and 12 months	2 adjacent fractures in PVP group
Buchbinder et al, 2009^Citation262	Multicenter, randomized, double-blind, placebo- controlled trial	71	Percutaneous vertebroplasty vs Sham	I-A	6 months	Pain score, QUALEFFO, Assessment of Quality of Life (AQoL), RMDQ, EQ-5D	Change in Pain Score: PVP: 2.4±3.3 Sham: 2.1±3.3 Difference: 0.1 (95% CI −1.2 to 1.4) Change in QUALEFFO Score: PVP: 6.4±13.4 Sham: 6.1±13.4 Difference: 0.6 (95% CI −5.1 to 6.2) Change in AQoL Score: PVP: 0.0±0.3 Sham: 0.1±0.3 Difference: 0.1 (95% CI −0.1 to 0.2) Change in RMDQ Score: PVP: 4.1±5.8 Sham: 3.7±5.8 Difference: 0.0 (−3.0 to 2.9) Change in EQ-5D Score: PVP: 0.2±0.4 Sham: 0.2±0.4 Difference: 0.0 (−0.1 to 0.2)	7 new vertebral fractures 3 new rib fractures 1 case of osteomyelitis
Kallmes et al, 2009^Citation261	Multicenter, RCT	131	Percutaneous vertebroplasty vs Sham	I-A	1 month	Pain intensity, RMDQ	RMDQ: PVP: 12.0±6.3 Sham: 13.0±6.4 Treatment Effect: 0.7 (95% CI −1.3 to 2.8, p=0.49) Pain Intensity: PVP: 3.9±2.9 Sham: 4.6±3.0 Treatment effect: 0.7 (−0.3 to 1.7, p=0.19)	1 thecal sac injury 1 patient admitted with tachycardia and rigors
Wardlaw et al, 2009^Citation250	RCT, comparative study	300	Balloon kyphoplasty vs nonsurgical care	I-A	12 months	SF-36 PCS	SF-36 PCS Improvement at 1 month: BKP: 7.2 (95% CI 5.7–8.8) NSM: 2.0 (95% CI 0.4–3.6) p<0.0001	1 hematoma 1 UTI
Voormolen et al, 2007^Citation511	RCT, comparative study	34	Percutaneous vertebroplasty vs optimal pain medication (OPM)	I-A	2 weeks	VAS, analgesic use, QUALEFFO, RMDQ	Change in VAS: PVP: −2.1 OPM: −1.1 Difference: −1.5 (95% CI −3.2 to 0.2) Change in Analgesic Use: PVP: −0.7 OPM: +0.9 Difference: −1.5 (95% CI −2.3 to −0.8) Change in QUALEFFO: PVP: −6.8 OPM: −0.7 Difference: −6.1 (95% CI −10.7 to −1.6) Change in RMDQ: PVP: +19 OPM: −2 Difference: 21 (95% CI 0.07 to 0.35	2 patients with new VCFs

Abbreviations: RCT, randomized controlled trial; VAS, visual analog scale; ODI, Oswestry Disability Index; PKP, percutaneous kyphoplasty; PCKP, percutaneous curved kyphoplasty; WHOQoL, World Health Organization quality of life health questionnaire; EQ-5D, EuroQOL Health Questionnaire; TIVAD, titanium-implantable vertebral augmentation device; 95% CI, 95% confidence interval; BKP, balloon kyphoplasty; NRS, numeric rating scale; SF-36, Short Form Health Questionnaire; PCS, physical component summary; MCS, mental component summary; VCF, vertebral compression fracture; B-CTX, carboxyl-terminal collagen I crosslinks; BALP, bone alkaline phosphatase; TRACP, tartrate-resistant acid phosphatase; MDA, malondialdehyde; TAC, total antioxidant capacity; SOD, superoxide dismutase; QUALEFFO, quality of life questionnaire in patients with vertebral fractures; RMDQ, Roland-Morris Disability Questionnaire; AVBHr, anterior vertebral body height ratio; PVBHr, posterior vertebral body height ratio; MVBHr, midline vertebral body height ratio; BKP, balloon kyphoplasty; VBS, vertebral body stenting; PVP, percutaneous vertebroplasty; AQoL, Assessment of Quality of Life; OPM, optimal pain medication.

Table 24 ASPN Back Consensus Group Recommendations for Vertebral Augmentation

Recommendation	Grade	Level of evidence	Level of certainty
			Net benefit
Vertebral Augmentation	A	I-A	High

Table 25 Evidence Summary for Spinal Cord Stimulation

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
FBSS
North et al, 2005^Citation512	Randomized controlled trial	60	I-A	Success defined as >50% pain relief and patient satisfaction	At six months, 47.4% of FBSS patients had successful outcome with SCS versus 11.5% of the reoperation cohort
Kumar et al, 2008^Citation513,Citation514	Randomized controlled trial	100	I-A	Success defined as >50% pain relief	At 24 months, 47% of FBSS patients had successful outcome with SCS versus 7% of the conventional medical management cohort
Kapural et al, 2016^Citation515,Citation516	Randomized controlled trial	198	I-A	Success defined as >50% pain relief	At 24 months, ≥50% pain reduction of LBP was seen in 76.5% of 10 kHz SCS patients compared to 49.3% in the paresthesia-based arm (p<0.001). Also, responder rate was 72.9% in the 10 kHz SCS arm versus 49.3% in the paresthesia-based arm for leg pain (p<0.001).
De Andres et al, 2017^Citation517	Randomized controlled trial	60	I-A	VAS (leg and back)	At 12 months, the authors reported that pain scores did not differ between the two arms. This was also true of the other primary outcome measures
Deer et al, 2018^Citation518	Randomized controlled trial	121	I-A	Mean daily VAS score, responder rate (defined as ≥30% pain relief)	Superiority of burst stimulation over paresthesia-based stimulation was achieved (p < 0.017). Also, 60% of patients were responders to burst stimulation versus 51% with tonic stimulation.
Mekhail et al, 2020^Citation519	Randomized controlled trial	134	I-A	Success defined as >50% pain relief	At 12 months, 83.1% of the ECAP-controlled arm had >50% pain relief versus 61% of the control arm.
Non-operated back pain
Al-Kaisy et al, 2018^Citation520	Prospective case series	20	I-B	Pain relief, disability, opioid use	Reductions in VAS (79±12 mm to 10±12mm), disability (ODI; 53±13 to 19.8±12), and opioid use were seen at 36 months.
Baranidharan et al, 2021^Citation521	Prospective case series	25	I-B	Pain relief, disability, quality of life, opioid use	At 12 months, back pain VAS scores improved by 4.6 points and leg pain VAS scores improved by 2.7 points. ODI was reduced by 22.1 points. EQ-5D-5L was increased by 23 points. Opioids were discontinued in 42.8% of patients.
Lumbar spinal stenosis
Costantini et al, 2010^Citation522	Retrospective case series	69	I-C	Pain relief, disability, medication usage	VAS improved from baseline 7.4±2.3 to 2.8±2.4 (p<0.05). Opioid use decreased from 29% of patients to 13%, NSAIDs from 75% to 49%, antidepressants from 33% to 20%, and antiepileptics from 32% to 9% (p<0.05). ODI decreased from 34.3±7.6 to 15.7±13.1 (p<0.05)
Kamihara et al, 2014^Citation523	Retrospective case series	41	I-C	Success defined as continued SCS use for one year or more after implantation	95.1% of patients continued to use their SCS for one year or more after implantation

Abbreviations: FBSS, failed back surgery syndrome; SCS, spinal cord stimulation; LBP, low back pain; VAS, visual analog scale; ECAP, evoked compound action potential; ODI, Oswestry Disability Index; EQ-5D, EuroQOL Health Questionnaire; NSAID, nonsteroidal anti-inflammatory drug.

Table 26 ASPN Back Consensus Group Recommendations for Spinal Cord Stimulation

Recommendation	Grade	Level of evidence	Level of certainty Net benefit
SCS following lumbar spinal surgery	A	I-A	Strong
SCS in the treatment of non-surgical LBP	B	I-C	Moderate
SCS in the treatment of patients with predominate lumbar spinal stenosis	C	I-C	Moderate

Abbreviation: LBP, low back pain.

Table 27 Disease Indications for Intrathecal Drug Delivery

Axial neck or back pain (not a surgical candidate)

Multiple compression fractures Discogenic pain Spinal stenosis Diffuse multiple-level spondylosis

Failed back surgery syndrome/Post-laminectomy syndrome

Trunk pain Postherpetic neuralgia Post-thoracotomy syndromes

Abdominal/pelvic pain Visceral Somatic

Extremity pain Radicular Joint

Complex regional pain syndrome (CRPS)

Cancer pain, primary invasion, metastasis, and treatment (chemotherapy, radiation)-related

Analgesic efficacy with systemic opioid delivery complicated by intolerable side effects

Note: Data from these studies.^23,24

Table 28 Key Considerations for Patient Selection

Contraindications

Indications

Immunocompromised patients or active infection Severe psychological conditions, including untreated significant addiction; active psychosis; major uncontrolled depression or anxiety; active suicidal or homicidal behavior; severe cognitive deficits; severe sleep disturbances Inability to comply with medication refill schedule Current or anticipated lack of insurance coverage or mean to pay for ongoing management of the pump

Chronic pain with a clear, appropriate diagnosis resulting in significant interference with of ADLs including ability to work and overall QOL Has tried and failed to achieve sufficient analgesia with less invasive therapies Optimization of all preexisting comorbidities Absence of severe or uncontrolled psychological conditions Patients in which oral opioid therapy is contraindicated

Abbreviations: ADL, activities of daily living; QOL, quality of life.

Table 29 Complications Associated with IDDS

Catheter-related Catheter damaged/severed/nicked/broken/fractured Catheter kink/twisting Catheter migration Catheter occlusion Catheter disconnection Fluid collection around the catheter

Pump-related Motor stall Corrosion Gear wear Pump flipped Pump empty/low volume Premature battery depletion MRI compatibility issues

Drug-related Drug withdrawal Drug overdose Nausea/vomiting Diaphoresis Pruritus Sedation/somnolence/lethargy Cardiovascular events Respiratory depression Edema of lower limbs Urinary retention/incontinence Sexual dysfunction/hypogonadotropic hypogonadism Osteoporosis Neuroendocrine dysfunction Constipation Hyperalgesia or allodynia Neuropsychiatric events

Procedural/Biological causes Granuloma Bleeding/epidural hematoma/spinal hematoma/pocket hematoma Meningitis Infection/erosion CSF leak/hygroma/post dural puncture headache Intracranial hypotension Seroma Allergic reaction Pump site discomfort

Note: Data from these studies.^{297,322–324}

Abbreviations: MRI, magnetic resonance imaging; CSF, cerebrospinal fluid.

Table 30 Evidence Summary for Intrathecal Drug Delivery Systems

Author, year	Intervention, patient type, sample size	Study type, level of evidence	Key findings
Ade et al, 2020^Citation524	Intrathecal (IT) hydromorphone + bupivacaine (n=30) vs IT fentanyl + bupivacaine (n=28) in patients with FBSS.	Retrospective comparative analysis, I-C	Fentanyl admixture with bupivacaine showed similar efficacy to hydromorphone + bupivacaine. Lower rate of opioid escalation was noted in the fentanyl group.
Anderson et al, 1999^Citation525	IT morphine in 30 patients with chronic noncancer pain (n=14 FBSS, n=1 chronic LBP).	Prospective, I-B	IT morphine is safe and effective for the management of severe, noncancer pain. Long-term improvement in daily function was also noted.
Atli et al, 2010^Citation526	IT opioids in 57 patients with chronic refractory pain including 28 FBSS and more patients with neuropathic/radicular or axial back pain.	Retrospective, I-C	Reduction of VAS and oral opioid consumption through 3-year follow-up. Noted 20% complication rate.
Deer et al, 2002^Citation313	IT opioid (pre) vs IT opioid + bupivacaine (post) in 109 patients (n=84 with FBSS, n=25 with metastatic cancer pain of spine).	Retrospective, I-C	IT bupivacaine provided additional analgesic benefit and reduction of oral opiate when added to IT opiate.
Deer et al, 2004^Citation288	IT morphine in 136 patients with LBP.	Prospective, I-B	Significant pain reduction, improvement in QOL, and patient satisfaction reported at both 6- and 12-month follow-up.
Doleys et al, 2006^Citation527	IT opioids (n=50) vs oral opioids (n=40) vs pain Rehabilitation program (n=40) in FBSS.	Retrospective, I-C	IT opiate group appeared to statistically significantly superior in numerical pain rating improvement.
Duse et al, 2009^Citation315	IT morphine in 30 patients with refractory noncancer pain, including 14 who presented with osteoporosis-related back pain, FBBS, or spinal arthrodesis	Prospective, I-B	IT morphine therapy effectively improved psychosocial function in patients with refractory pain that had failed to respond to standard multimodal therapy.
Galica et al, 2018^Citation528	IT hydromorphone and bupivacaine in FBBS (n=54).	Retrospective, I-C	Combination therapy with IT hydromorphone and bupivacaine improved pain intensity scores in patients with FBSS at 12 and 24 months.
Grider et al, 2016^Citation529	Low-dose intrathecal opioid in 58 patients with analysis by age, gender, diagnosis and pre-implantation opioid dosage	Prospective I-B	Significant sustained 3 year reduction in VAS at less than 0.5 mg per day opioid
Hamza et al, 2012^Citation306	IT opioid in 58 patients with chronic noncancer pain including 35 FBSS and 16 LBP patients.	Prospective, I-B	Statistically significant reduction in both worst and average pain through a 36-month follow-up (6, 12, 18, 24, 36 months follow-ups)
Hayek et al, 2016^Citation530	IT hydromorphone + bupivacaine in 57 patients with FBSS	Retrospective, I-C	Patient-controlled delivery of IT hydromorphone and bupivacaine are effective in treating chronic pain due to FBSS. IT dose escalation was noted.
Ilias et al, 2008^Citation531	Patient controlled analgesia IT therapy using personal therapy manager device (opioids with or without clonidine, bupivacaine, baclofen, and/or midazolam) in 168 patients with existing IDDS for chronic refractory pain (92% noncancer; most commonly FBSS, 8% cancer).	Prospective, I-B	A significant reduction of the overall average VAS at 12 months.
Kanai et al, 2019^Citation308	IT bupivacaine (0.5, 1.0, and 1.5mg at 1-week intervals) for chronic LBP and lower extremity, n=70.	Prospective, I-B	IT bupivacaine was safe and effective at least through 12 months, with 1.0 mg as the optimal dose.
Rainov et al, 2001^Citation310	IT combination therapy (morphine admixed with bupivacaine, clonidine, or midazolam) in 26 patients with chronic noncancer back and leg pain due to degenerative lumbar spinal disorder.	Prospective, I-B	IT combination therapy can have a favorable and sustained efficacy in patients with chronic refractory pain of spinal origin. No drug-related complications noted through up to 27 months.
Rauck et al, 2006^Citation532	IT ziconotide (n=112) vs placebo (n=108).	RCT, I-A	IT ziconotide group showed statistically significant improvement in VASPI.
Rauck et al, 2013^Citation533	IT gabapentin in 170 chronic noncancer patients including 116 patients with back pain with or without leg pain.	Multicenter RCT, I-A	IT gabapentin was as safe as oral gabapentin without statistically significant analgesic effect. Study length = 22 days.
Rauck et al, 2010^Citation534	IT morphine in 110 patients (60 FBSS, 6 compression fractures). 8 patients later excluded.	Prospective, I-B	Decrease in pain and disability in 68.4% of patient visits for up to 6 months. 28 patients with “serious” adverse events.
Raphael et al, 2002^Citation311	IT opioid in 36 patients with chronic LBP.	Retrospective, I-C	Retrospective patient questionnaire revealed significant improvement in pain and QOL.
Roberts et al, 2001^Citation318	IT morphine in 88 patients with chronic noncancer pain (n=64 with back pain; 55 with FBSS, 6 with back pain without surgery, 3 with compression fracture).	Prospective, I-B	A majority of patients had significant pain relief, improved physical activity levels, and reduction in oral medications through average of 36 months.
Shaladi et al, 2007^Citation535	IT morphine in 24 patients with chronic vertebral compression fractures	Prospective, I-B	IT morphine resulted in significant improvement of pain and all variables of QUALEFFO including quality of daily life, domestic work, ambulation, and perception of health status at 12 months.
Staats et al, 2007^Citation536	IT opioid therapy with or without adjunct agents in 101 patients with chronic noncancer back pain.	Retrospective, I-C	Patients with noncancer LBP can be maintained with constant flow rate pump throughout treatment.
Veizi et al, 2011^Citation317	IT opioids (59% FBSS) vs IT opioid + bupivacaine (50% FBSS). Total n = 126.	Retrospective, I-C	Both groups with significant reduction in pain intensity and oral opioid consumption. Adjunct therapy with bupivacaine blunted IT opioid dose escalation.
Wallace et al, 2008^Citation320	IT ziconotide as adjunct to IT morphine in 26 patients with chronic refractory noncancer pain (n=23 FBSS).	Prospective, I-B	Addition of IT ziconotide as adjunct to IT morphine increases analgesic efficacy and reduce oral opioid dosage at 18 months.
Winkelmuller et al, 1996^Citation537	IT morphine with various adjunct therapies (buprenorphine, clonidine, fentanyl, bupivacaine, or NaCl) in 120 patients with FBSS.	Retrospective, I-C	Patients continued to report pain reduction through variable follow-up periods, from 6 months to 5.7 years.

Abbreviations: FBSS, failed back surgery syndrome; LBP, low back pain; IT, intrathecal; QUALEFFO, Questionnaire of the European Foundation of Osteoporosis; VASPI, Visual Analogue Scale of Pain Intensity; VAS, visual analog scale; QOL, quality of life; RCT, randomized controlled trial.

Table 31 ASPN Back Consensus Group Recommendations for Intrathecal Drug Delivery Systems

Recommendation	Grade	Level	Level of certainty
			Net benefit
Intrathecal drug delivery is safe and effective in chronic refractory pain of spinal origin.	B	I-B	Moderate
Intrathecal drug delivery is safe and effective in refractory failed back surgery syndrome.	A	I-A	High
Intrathecal ziconotide is safe and effective for chronic non-cancer pain management.	A	I-A	High
Intrathecal opioids are safe and effective in chronic non-cancer pain management.	B	I-B	Moderate
Intrathecal bupivacaine is safe and effective for chronic non-cancer pain management.	B	I-C	Moderate
Intrathecal drug delivery can help minimize medication utilization through oral route	B	I-B	Moderate
Intrathecal combination drug therapy is effective in chronic refractory pain of spinal origin.	B	I-C	Moderate
Intrathecal drug therapy can help improve function and quality of life in chronic refractory pain of spinal origin.	B	I-C	Moderate
Intrathecal ziconotide can augment opioid analgesic effect	B	I-B	Moderate
Intrathecal combination (opioids + local anesthetic ± ziconotide) therapy can prolong the development of intrathecal opioid tolerance	C	I-C	Moderate
Shared decision making should be utilized if contemplating intrathecal drug therapy in patients with multiple co-morbidities affecting cardiopulmonary function, hematopoietic function, or central nervous function.	A	I-C	Moderate

Table 32 Evidence Summary for Multifidus Activation via Medial Branch Nerve Stimulation

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Deckers et al, 2018^Citation336	Prospective, multi-center, single-arm, non-randomized trial	53	I-B	NRS (back), ODI, EQ-5D	The percentage of subjects at 90 days, 6 months, and 1 year with greater than or equal to MCID in single day NRS was 63%, 61%, and 57% respectively. The percentage of subjects with greater than or equal to MCID in EQ-5D was 88%, 82%, and 81% respectively. There were no unanticipated adverse events related to the device, procedure, or therapy.
Cohen, et al, 2019^Citation337	Case-series	9	II	Daily pain levels and analgesic medication consumption in weekly diaries and once weekly visits to assess pain, disability, and adverse events, ODI, BPI-9, PGIC	At one month, 67% of patients experienced highly clinically significant reductions in average BPI vs baseline. The mean reduction in average pain intensity in all subjects was 59% with average 76% reduction in non-opioids and 100% reduction in opioid, with 67% experiencing significant improvement in ODI and reduction in BPI.
Ilfeld et al, 2017^Citation338	Retrospective literature review	43	I-C	Rate of infection/1000 indwelling days; Rate of infection in the 1^st 30 and 60 days	The risk of infection with non-coiled leads was estimated to be 25 times greater than with coiled leads. The infection rates were estimated to be 0.03 infections per 1000 indwelling days for coiled leads and 0.83 infections per 1000 indwelling days for non-coiled leads.
Gilligan et al, 2021^Citation339	Randomized, multi-center, active- sham-controlled clinical trial	204	I-A	Comparison of responder subjects with greater than or equal to 30% relief on VAS (LBP) without analgesic increase at 120 days; ODI, EQ-5D, PPR, PGIC, and LBP resolution	The primary endpoint comparing the responder proportions was inconclusive in superiority; however, prespecified secondary outcomes and analyses were consistent with a modest but clinically significant meaningful treatment benefit at 120 days.
Gilligan et al, 2021^Citation340	Open-label follow up of randomized, active-sham-controlled trial	204	I-C	VAS, ODI, EQ-5D-5L, opioid intake at 6, 12, and 24 months	At two years, 76% subjects experienced ≥50% CLBP relief and 65% reported CLBP resolution; 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI.
Kapural et al, 2018^Citation341	Case report	2	II	BPI, ODI	2 subjects experienced clinically significant reductions in average BPI at end of therapy, which was sustained at 4 months with at least 50% reduction in ODI and 83% reduction in BPI, revealing the utility of minimally invasive neuromodulation therapy
Gilmore et al, 2019^Citation342	Case Series	9	II	BPI-3, BPI-5	Among responders at four months, the mean reduction in average pain intensity (BPI-5) and worst pain intensity (BPI-3) was 84% and 78%, respectively. Subject-reported reductions in pain intensity were substantiated by concomitant and sustained reductions in analgesic medication usage. Subjects also reported clinically significant reductions in patient-centric outcomes of disability (ODI), pain interference (BPI-9), and PGIC.
Thomson et al, 2021^Citation538	Post-market prospective clinical follow-up	42	I-B	NRS, ODI, EQ-5D-5L	Among the 37 patients completing 2-year follow-up, NRS pain scores improved from 7.0 ± to 3.5 ± 0.3, ODI scores improved from 46.2 ± 2.2 to 29.2 ± 3.1, and health-related quality of life improved from 0.426 ± 0.035 to 0.675 ± 0.030. Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.

Abbreviations: NRS, numeric rating scale; ODI, Oswestry Disability Index; EQ-5D, EuroQOL Health Questionnaire; MCID, minimum clinically important difference; BPI, Brief Pain Inventory; PGIC, patient global impression of change; VAS, visual analog scale; PPR, percentage pain relief; LBP, low back pain.

Table 33 ASPN Back Consensus Group Recommendations for Multifidus Activation via Medial Branch Nerve Stimulation

Recommendation	Grade	Level	Level of certainty
The incidence of serious procedure or device related complications is favorable to other neuromodulation techniques	B	1-B	Moderate
Improvements in baseline are clinically significant at both 1 and 2 years after implant in a cohort of patients with severe, disabling chronic LBP	B	1-B	Moderate
Improvements in pain and disability increase the longer duration of treatment	B	1-B	Moderate
The infection rate of non-coiled leads is 25 times higher than rate for coiled leads	C	I-C	Moderate
Percutaneous 60 day PNS may provide sustained improvements in pain and function	C	I-C	Moderate
Percutaneous PNS may reduce or eliminate need for analgesics in individuals with chronic LBP	C	II	Low

Abbreviations: LBP, low back pain; PNS, peripheral nerve stimulation.

Table 34 Evidence Summary for Peripheral Nerve Field Stimulation

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Verrills et al, 2009^Citation539	Retrospective analysis	14 patients (13 patients responded)	I-C	- pre and post procedure VAS scores - employment, medication usage, and patient satisfaction	- Mean VAS score pre-treatment was 7.42, and post-treatment was 3.92. - 7/13 patients decreased pain medications - 10/13 satisfied with procedure outcome
Sator-Katzenschlager et al, 2010^Citation540	Retrospective multi-center analysis	111 patients	I-C	- pre-procedure NRS scores and post -procedure NRS scores (weekly for at least 3 months)	- FBSS patients: mean NRS score was 8.0 pre-implantation and 3.3 afterwards. - Chronic LBP patients: mean NRS score was 8.3 pre-implantation and 4.2 afterwards.
Yakovlev et al, 2011^Citation541	Retrospective analysis	18 patients	I-C	- pre and post procedure VAS scores - pre and post procedure opioid use	- Mean pre procedure VAS score = 7.4 - Mean post procedure VAS score = 1.7 (12 month follow up) - At 12 month follow up 11/18 patients stopped opioids entirely
Verrills et al, 2011^Citation542	Prospective observational study	100 patients	I-B	- pre and post PNFS implantation VAS scores - pre and post PNFS implantation ODI scores	- Average follow up for patients with lumbo-sacral pain = 7.2 months - Reduction in VAS by 3.3 (p ≤ 0.000) - Statistically significant reduction in ODI (p ≤ 0.033)
McRobers et al, 2013^Citation543	Prospective, multi-center, double-blinded, crossover RCT	32 patients were trialed and 23 patients had leads permanently implanted	I-B	- pre and post PNFS implantation VAS scores - SF-36 assessing quality of life, medication dosage and frequency	- Mean VAS scores decreased from 7.8 to 3.5 at 52 week follow up - At 52 weeks 16/23 patients still reported > 50% pain relief - SF-36 improved from 16.9 to 27.9 at 52 weeks (p < 0.001) - 43% of patients either decreased dose/frequency or stopped previous opiate medications
Kloimstein et al, 2014^Citation544	Prospective, multi-center, observational study	118 patients enrolled and 105 people implanted with PNFS	I-B	- VAS scores, ODI, BDI, SF-12	- Mean VAS pre-trial was 7.9, and 4.7 at 6 months post PNFS implantation (p < 0.01) - Improvement of ODI from 38.2 to 34.6 (p < 0.01) at 6 month follow up - Improvement of BDI from 17.8 to 15.1 (not statistically significant) - SF-12 score improvement from 4.29 to 3.67 (p < 0.01) at 6 months
Ishak et al, 2018^Citation545	Prospective, single center, observational study	26 patients enrolled and 13 had leads permanently implanted	I-B	- VAS scores, ODI, and EQ-5D-3L scores measuring quality of life - Pain medication usage at 24 months	- Statistically significant (p < 0.01) improvement in VAS, ODI and EQ-5D-3L scores pre-trial vs post implantation at 24 months - 77% decrease in NSAID use and 92% decrease in overall opioid use when compared to pre-implantation
Eldabe et al, 2019^Citation546	Prospective, multi-center, unblinded, RCT	116 patients	I-B	- VAS scores, ODI scores, EQ-5D-5L and SF-36 (quality of life evaluation)	- Statistically significant (p < 0.0001) improvement in VAS score after implantation at 9 months (68.8/100 decreased to 36.9/100), and also statistically significant improvement in ODI (p < 0.0001), EQ-5D-5L (p = 0.0003) and SF-36 (p = 0.0062)
van Gorp et al, 2019^Citation547	Prospective, multi-center, unblinded, RCT	52 patients enrolled (50 patients were implanted & completed 12 month follow up)	I-B	- VAS scores, ODI scores, HADS anxiety component score, MOSS scores, and MPQ scores	- Statistically significant improvement in VAS was noted at 12 months (p < 0.001) compared to baseline. - ODI score improvement from 57.1 to 40.4 at 12 months (p < 0.05). - Statistically significant improvement in HADS anxiety component score, MOSS scores, and MPQ scores at 12 month follow up (p < 0.05)

Abbreviations: VAS, visual analog scale; NRS, numeric rating scale; LBP, low back pain; PNFS, peripheral nerve field stimulation; ODI, Oswestry Disability Index; BDI, Beck Depression Inventory; SF-12/36, Short Form Health Survey; EQ-5D, EuroQOL Health Questionnaire; NSAID, nonsteroidal anti-inflammatory drug; HADS, Hospital Anxiety and Depression Scale; MOSS, Medical Outcomes Study-Sleep; MPQ, McGill Pain Questionnaire.

Table 35 ASPN Back Consensus Group Recommendations for Peripheral Nerve Field Stimulation

Recommendation	Grade	Level	Level of certainty
			Net benefit
PNFS can be considered in patients with chronic axial low back, with and without radicular symptoms in their lower extremities, who have failed other treatment modalities.	C	I-B	Moderate

Table 36 Evidence Summary for Lumbar Radiofrequency Ablation

Study	Study type	Sample size	Outcomes measure(s)	Evidence level	Other
Van Wijk et al^Citation548	RCT	81	VAS, SF-36, global perceived effect	I-A	No difference from Sham – one diagnostic block
Van Kleef et al^Citation51	RCT	31	VAS, global perceived effect, ODI	I-A	Significant difference at 3,6,12; one block performed
Nath et al^Citation52	RCT	40	Pain Scores, global perceived effect, hip movement, SI joint test	I-A	3 diagnostic blocks performed; independent observer (orthopedic surgeon); Improvement in back pain and hip pain/movement
Leclaire et al^Citation549	Sham controlled	70	VAS, RMQ, ODI	I-A	Facet blocks prior to RFA; Sham RFA (no current) vs RFA. Results show short term relief, but efficacy not established
Gofeld et al^Citation550	Prospective audit	174 of 209 completed study	Questionnaire – total perceived pain reduction, reduction in pain medicine, functional improvement	I-B	Dual diagnostic medial branch blocks; Patient reported questionnaires at 6 weeks, 6,12,24 months. 68% showed at least 50% pain reduction from 6–24 months.
McCormick^Citation62	Single center, prospective outcomes	62	Percentage pain reduction, NRS score, MQS score	I-B	At least 1 diagnostic block with 75% pain reduction; > or = to 50% pain reduction and functional improvement; Median follow-up 39 months; 58% and 53% improved in function and pain reduction, respectively; RFA is a durable treatment
Yadav et al^Citation551	Single center, retrospective cohort	500	Responder >30% improvement in pain scores	I-C	Responders were > or = 30% pain reduction after diagnostic block; 1 year follow-up; patients with high preoperative opioid use were less responsive at 1 year
Tekin et al^Citation53	RCT	20 RFA, 20 Pulsed, 20 Sham	VAS, ODI	I-A	All groups reported a clinically significant reduction in pain from pre-procedure scores at 6 and 12 months
Kroll et al^Citation552	Prospective, Randomized, Double-blinded study	50, 26 on follow-up	VAS, ODI	I-B	Dual diagnostic blocks at least two levels; Randomized to C-RFA or P-RFA; No difference between groups in VAS or ODI; P-RFA no significant difference over time; C-RFA shows significant improvement over time
Cetin and Taktas^Citation553	Prospective, Double blinded; comparative	75 P-RFA; 43 C-RFA	VAS, Odom criteria	I-B	Follow-up months 1,3,4,12 and 24; C-RFA procedure more satisfied patients with less need for re-treatment compared to P-RFA
Colini-Baldeschi^Citation554	Observational	300	NRS	I-C	Single diagnostic block; 186 of 300 reported good pain relief at 6 months after P-RFA
Mikeladze et al^Citation555	Retrospective	83 of 114 with back pain	VAS	I-C	68 of 118 patients received pain relief following P-RFA and after a single diagnostic block; mixed study with both cervical and lumbar facet pain
Linder et al^Citation556	Retrospective with crossover	48	NRS	I-C	Single diagnostic block; crossover to C-RFA if P-RFA not successful at 1 month
McCormick et al^Citation557	Blinded, prospective comparative	43 total, cooled RFA 22, conventional 21	NRS at 6 months, NRS, ODI, PGIC	I-B	Single diagnostic block > 75% pain relief; 52%/42% experienced > or = 50% pain reduction; > or = 15 point or > or = 30% 62%/42% in cooled or conventional, respectively; Cooled RFA results in > or = 50% reduction in pain when single diagnostic block used.

Abbreviations: VAS, visual analog scale; SF-36, Short Form Health Questionnaire; ODI, Oswestry Disability Index; SI, sacroiliac; RMQ, Roland Morris Disability Questionnaire; RFA, radiofrequency ablation; NRS, numeric rating scale; MQS, Medication Quantification Scale; PGIC, patient global impression of change.

Table 37 ASPN Back Consensus Group Recommendations for Lumbar Radiofrequency Ablation

Recommendation	Grade	Level	Consensus
Conventional radiofrequency ablation is effective for low back pain	A	I-A	High
Conventional RFA is superior to pulsed RFA	B	I-B	Moderate
Pulsed RFA is not efficacious	D	I-B	Moderate
Conventional RFA and cooled RFA are equally efficacious	A	I-A	Strong

Table 38 Evidence Summary for Sacroiliac Radiofrequency Ablation

Author	Study type and size	Outcome measures	Key findings	Level of evidence
Cohen et al 2008^Citation363	RCT N=28 Sham controlled	>75% relief NRS	Radiofrequency is superior (79%) to sham (14%) at 1 month	I-A
Patel et al 2012^Citation364	RCT N=51 Sham Controlled	>75% Relief NRS	Radiofrequency is superior (47% responder rate [RR]) to sham (12% RR) at 3 months	I-A
van Tilburg et al, 2016^Citation368	RCT N=60 Sham controlled	>2 point NRS decrease after sacroiliac joint injections	Radiofrequency is not superior to sham	I-A
Salman et al, 2016^Citation558	RCT N=30 Steroid versus RF	>75% relief NRS	Radiofrequency is superior (53% RR) to single shot steroid injection (20% RR)	I-A
Juch et al, 2017^Citation559	RCT N-228, RF+ Exercises compared to Exercise alone	>50% relief NRS	>30% NRS improvement in 51% in RF and 49% exercise group. No significant difference	I-A

Abbreviations: RCT, randomized controlled trial; NRS, numeric rating scale; RR, responder rate; RF, radiofrequency.

Table 39 ASPN Back Consensus Group Recommendations Sacroiliac Radiofrequency Ablation

Recommendation	Grade	Level of evidence	Level of certainty Net benefit
SI joint denervation/ablation is effective in treatment of SI joint dysfunction pain and is superior to sham in RCT	B	I-A	Strong

Abbreviation: RCT, randomized controlled trial.

Table 40 Evidence Summary for Basivertebral Radiofrequency Ablation

Source, year	Design	Sample size	Level of evidence	Outcome measures	Results
Smuck et al, 2021^Citation560	Prospective, multicenter, open label RCT	140	I-B	ODI, VAS	Mean ODI reduction, difference between arms of −20.3 (CI −25.9 to −14.7 points; p < 0.001) Mean VAS pain improvement (difference of −2.5 cm between arms (CI −3.37 to −1.64, p < 0.001)
Koreckij et al, 2021^Citation561	Prospective, open label, single-arm RCT	140	I-B	ODI, VAS, SF-36, EQ-5D-5L, responder rates	Improvements in ODI, VAS, SF-36 and EQ-5D-5L were statistically significant at 24-month follow up Mean ODI change improved 28.5±16.2 points (from baseline 44.5; p < 0.001) Mean VAS change improved 4.1±2.7 cm (from baseline 6.6; p < 0.001 Responder Rates: A combined responder rate of ODI≥15 and VAS≥2 was 73.7% A ≥50% reduction in pain was reported in 72.4% of patients and 31.0% were pain-free at 2 years At 24 months, only 3(5%) of patients had BVNA-level steroid injections, and 62% fewer patients were actively taking opioids
Macadaeg et al, 2020^Citation395	Prospective, open-label, single-arm, multicenter	47	I-B	ODI, VAS, Responder Rates, SF-36, EQ-5D-5L	Mean ODI change of −32.6 Mean VAS change of −4.3 Responder Rates: 15-point ODI reduction – 88.9% 20-point ODI reduction – 88.4% 2.0 cm VAS reduction – 80.0% SF-36 Total Score increase of 26.3 EQ-5D-5L increase of 0.22
De Vivo et al, 2020^Citation403	Prospective uncontrolled trial	56	I-B	ODI, VAS, Responder Rates	Mean ODI change of −32.4 Mean VAS change of −4.3 Responder Rates: 10-point ODI reduction - 96.4% 2-point VAS reduction - 96.4%
Fischgrund et al, 2020^Citation402	Open-label follow-up study of RCT treatment arm	100	I-B	ODI, VAS, Responder Rates, Opioid Use	Mean ODI change of −25.9 Mean VAS change of −4.4 Responder Rates: 15-point ODI reduction - 77% 2-point VAS reduction - 88% Combined (ODI ≥ 15 and VAS ≥ 2) - 75% In patients on opioids at baseline: Stopped use – 73.3%
Kim et al, 2020^Citation370	Prospective case series	30	I-C	ODI, VAS, MacNab criteria	Mean ODI change of −52.7 Mean VAS change of −5.7 MacNab criteria: Excellent outcomes – 56.7% Good outcomes – 36.7% Fair outcomes – 6.7%
Markman et al, 2020^Citation401	Post-hoc analysis of sham-controlled trial	69	II	ODI, Opioid Use	Treatment arm: Decreased opioid use (n=27) mean ODI change −24.9 Increased opioid use (n=18) mean ODI change −7.3 Sham arm: Decreased opioid use (n=19) mean ODI change −17.4 Increased opioid use (n=5) mean ODI change −1.2
Khalil et al, 2019^Citation400	Prospective, randomized, multicenter	104	I-A	ODI, VAS, Responder Rates, SF-36, EQ-5D-5L, Opioid Use	Mean ODI change of −25.3 (treatment) vs −4.4 (control) Mean VAS change of −3.5 (treatment) vs −1.0 (control) Responder Rates: 20-point ODI reduction – 62.7% (treatment) vs 13.5% (control) 2-point VAS reduction – 72.5% (treatment) vs 34.0% (control) SF-36: PCS – increase 14.02 (treatment) vs 2.114 (control) MCS - increase 2.615 (treatment) vs 2.786 decrease (control) EQ-5D-5L Increase 0.1803 (treatment) vs 0.0135 (control) No change in opioid use in either arm at 3 months
Fischgrund et al, 2019^Citation399	Open-label follow-up study	106	I-C	ODI, VAS, Responder Rates, SF-36, Opioid Use	Mean ODI change of −23.4 Mean VAS change of −3.6 Responder Rates: 10-point ODI reduction - 76.4% 20-point ODI reduction – 57.5% 1.5 cm VAS reduction – 70.2% SF-36 PCS increase of 11.84 In patients on opioids at baseline: Reduced use – 60.7% Stopped use – 46.4%
Truumees et al, 2019^Citation398	Prospective, open-label, single-arm, multicenter	28	I-B	ODI, VAS, Responder Rates, SF-36, EQ-5D-5L	Mean ODI change of −30.1 Mean VAS change of −3.5 Responder Rates: 10-point ODI reduction – 92.9% 20-point ODI reduction – 75.0% 2.0 cm VAS reduction – 75.0% SF-36 PCS increase of 15.78 SF-36 MCS increase of 4.23 EQ-5D-5L increase of 0.198 50% (4/8) patients taking extended-release narcotics had stopped by 3 months post procedure.
Kim et al, 2018^Citation392	Single center retrospective observational	14	I-B	VAS, MacNab criteria	Mean VAS change of −5.4 MacNab criteria: Excellent outcomes – 50.0% Good outcomes – 42.9% Fair outcomes – 7.1%
Fischgrund et al, 2018^Citation397	Prospective, randomized, double-blind, sham-controlled, multicenter	225	I-A	ODI, VAS, Responder Rates, SF-36	3 Month Primary Endpoint (per protocol): Mean ODI change of −20.3 (treatment) vs −15.4 (control) Mean VAS change of −2.9 (treatment) vs −2.5 (control) 12 Month Primary Endpoint (per protocol): Mean ODI change of −19.8 (treatment) vs −15.9 (control) Mean VAS change of −2.8 (treatment) vs −2.2 (control) Responder Rates 3 Month (per protocol): 10-point ODI reduction – 75.6% (treatment) vs 55.3% (control) SF-36 - 3 Month (per protocol): PCS – increase 9.74 (treatment) vs 9.05 (control) MCS - increase 2.24 (treatment) vs 0.78 (control) SF-36 - 12 Month (per protocol): PCS – increase 9.17 (treatment) vs 7.63 (control) MCS - increase 1.13 (treatment) vs 1.46 decrease (control)
Becker et al, 2017^Citation391	Prospective, single-arm, multicenter pilot	16	I-B	ODI, VAS, Responder Rates, SF-36	Mean ODI change of −29 Mean VAS change of −16 mm Responder Rates: 10-point ODI reduction – 81% SF-36 PCS increase of 7.2

Abbreviations: RCT, randomized controlled trial; ODI, Oswestry Disability Index; VAS, visual analog scale; CI, 95% confidence interval; SF-36, Short Form Health Questionnaire; PCS, physical component summary; MCS, mental component summary; EQ-5D, EuroQOL Health Questionnaire; BVNA, basivertebral nerve ablation.

Table 41 ASPN Back Consensus Group Recommendations for Basivertebral Nerve Ablation

Recommendation	Grade	Level of evidence	Level of certainty
			Net benefit
Basivertebral nerve ablation	A	I-A	High

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