A review of prospective studies regarding percutaneous peripheral nerve stimulation treatment in the management of chronic pain

Figures & data

Figure 1. Flow chart for literature search. Publications that met the inclusion criteria are summarized by the publication count in parentheses and the number of unique study cohorts.

Table 1. Review and synthesis of publications of prospective studies of percutaneous PNS treatment to manage chronic pain.

Pain region	Study cohort	Study design	Indication	Group size(s)	Nerve target(s)	PNS treatment period	Definition of treatment responder	Outcome timepoints from start of treatment	Proportion of treatment responders^§§		Ref.
Shoulder pain	1	Prospective case series	Hemiplegic shoulder pain	8	Axillary nerve; Suprascapular nerve	6 weeks	NR^#	EOT 3-mo	NR^#		[41]
	2	Prospective case series	Hemiplegic shoulder pain	15	Axillary nerve; Suprascapular nerve	6 weeks	NR^#	EOT 4-mo 7-mo	NR^#		[42]
	3	Multicenter, single-blinded, randomized controlled trial	Hemiplegic shoulder pain	32 PNS 29 Control (usual care)	Axillary nerve; Suprascapular nerve; Upper trapezius nerve terminals	6 weeks	≥2 point reduction in BPI-12 score	EOT 3-mo 6-mo	Treatment Group 84% (27/32) 66% (21/32) 63% (20/32)	Control Group 31% (9/29) 31% (9/29) 38% (11/29)	[36]^†
								12-mo	78% (25/32)	52% (15/29)	[37]^†
	4	Prospective case series	Hemiplegic shoulder pain	8	Axillary nerve	3 weeks^††	≥2 point reduction in BPISF-3 score	EOT 5-w 8-w 16-w	100% (8/8) 88% (7/8) 88% (7/8) 75% (6/8)		[38]
	5	Single center, randomized controlled trial	Hemiplegic shoulder pain	13 PNS 12 Control (usual care)	Axillary nerve	3 weeks^††	≥30% reduction in BPISF-3 score	EOT 10-w 16-w	Treatment Group 100% (12/12) 75% (9/12) 83% (10/12)	Control Group 38% (3/8) 22% (2/9) 22% (2/9)	[39]
	6	Prospective case series	Subacromial impingement syndrome	10	Axillary nerve	3 weeks^††	≥2 point and/or ≥30% reduction in BPISF-3 score	EOT 5-w 8-w 16-w	70% (7/10) 60% (6/10) 56% (5/9) 86% (6/7)		[40]
Neuropathic Pain	7	Prospective case series	Neuropathic pain following amputation	16	Femoral nerve; Sciatic nerve	2 weeks	≥30% reduction in BPISF-3 score (Residual Limb Pain/Phantom Limb Pain)	EOT 6-w	89% (8/9) 78% (7/9)		[44]
	8	Multicenter, double-blinded, randomized, placebo-controlled trial	Neuropathic pain following amputation	12 PNS 14 Control (placebo lasted through week 4)	Femoral nerve; Sciatic nerve	60 days	≥50% reduction in BPISF-5 score (Residual Limb Pain/Phantom Limb Pain)	EOT 3-mo 4-mo 5-mo 6-mo	Treatment Group 73% (8/11) 50% (5/10) 75% (6/8) 56% (5/9) 38% (3/8)	Control Group 0% (0/14) placebo 4 weeks only	[51]^‡
								7-mo 8-mo 9-mo 10-mo 11-mo 12-mo	56% (5/9) 75% (6/8) 67% (6/9) 57% (4/7) 71% (5/7) 63% (5/8)	NR	[52]^‡
Low Back Pain	9	Prospective case series	Axial low back pain	9	Medial branch nerve	30 days	≥50% reduction in average pain (BPISF-5) score	EOT 4-mo	67% (6/9) 80% (4/5)		[47]^§
							≥30% reduction in average pain (BPISF-5) score	7-mo	60% (3/5)		[48]^§
							≥50% reduction in average pain (BPISF-5) score and/or ≥10 point reduction in disability (ODI)	13-mo	67% (4/6)		[49]^§
	10	Prospective case series	Axial low back pain	74	Medial branch nerve	60 days	≥30% reduction in average pain (BPISF-5) score	EOT 5-mo 8-mo	73% (54/74) 59% (41/70) 53% (35/66)		[50]^¶
								11-mo 14-mo	58% (36/62) 58% (36/62)		[53]^¶
							≥50% reduction in average pain (BPISF-5) score	EOT 5-mo	67% (10/15) 80% (8/10)	Sub-study (n = 15)	[54]^‡‡

† Same study cohort; includes initial publication (EOT and 6-mo post-treatment) and follow-up (12-mo post-treatment).

‡ Same study cohort; includes initial publication (EOT, 4-week post-treatment) and follow-up (12-mo post-treatment).

§ Same study cohort; includes initial publication (EOT, 3-mo post-treatment and 6-mo post-treatment) and follow-up (12-mo post-treatment).

¶ Same study cohort; includes initial publication (EOT; 1-mo post treatment; 3-mo post-treatment) and follow-up study (12-mo post-treatment).

# No definition for ‘responder’ listed in original publication.

†† 3 weeks of active stimulation following a 1-week stabilization period.

‡‡ Follow-up study of cohort subset of participants who previously underwent RFA.

§§ In instances where the treatment responder definition was not reported for all outcome timepoints, the proportion of study participants reaching therapeutic efficacy was calculated from the participant level data.

BPI: Brief pain inventory; BPISF: Brief pain inventory short form; EOT: End of treatment; NR: Not relevant; PNS: Peripheral nerve stimulation; Ref: Reference.

Figure 2. Study outcomes timeline. Percutaneous PNS treatment period ranged from 14 to 60 days (green boxes). Reported outcome timepoints (triangles) were grouped as end-of-treatment, 3–5-month follow-up, 6–8-month follow-up and 12–14-month follow-up (months from therapy onset, orange boxes). Study cohort definitions and data sources are presented in Table 1.

EOT: End-of-treatment; PNS: Peripheral nerve stimulation.

Figure 3. Summary data and composite responder analysis. (A) Mean pain intensity by study cohort. (B) Mean average pain interference scores by study cohort. Overall mean pain intensity and pain interference scores presented as dashed black lines in (A & B). Participant-level data presented as individual outcomes (points) and mean ± standard error (lines and error bars). (C) Summary of composite responder rate for each timepoint. Composite responder defined as a participant who experienced highly clinically meaningful reduction (≥50%) in pain intensity and/or pain interference. Responder rates presented as a percentage of total study participants with data available at each time point. (D) Composite responder rate for each study cohort at EOT, with the overall summary of responder rate at EOT (73%) represented by the black dotted line. Data presented as mean ± 95% confidence interval (bars and error bars). (E) Color legend for study cohorts. Data sources are presented in Table 1.

Avg: Average; BPI: Brief pain inventory; EOT: End-of-treatment; mo: Month; NA: Not applicable.

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