Decompression nerve surgery for diabetic neuropathy: a structured review of published clinical trials

Figures & data

Table 1 Characteristics of studies of lower extremity DNS for diabetic peripheral neuropathy

Author (year) Study type; setting; study length; Delphi score (0–9)^Citation16	Participants	Intervention	Outcome(s)
Aszmann et al (2000)^Citation34,Citation37 (duplicates) Prospective, consecutive, unblinded, contralateral limb control; single-center; follow-up ≥12 months (mean: 23.3); Delphi score: 3	TIDM (n= 14) or T2DM (n=6); painful DPN; +Tinel (ankle or over other nerves decompressed)	DNS tibial (ankle); 6 of 20 had bilateral surgery; (8 subjects had DNS of median and/or ulnar nerves)	Sensation: 2PD
Aszmann et al (2004)^Citation50 Retrospective, contralateral limb control; single-center; follow-up ≥ 24 months (mean: 54); Delphi score: 2	TIDM or T2DM (n=50); DPN	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels	Ulcer or amputation
Dellon (1992)^Citation41 Prospective, consecutive, unblinded, contralateral limb control (some); singlecenter; follow-up ≥ 6 months (mean: 30); Delphi score: 2	TIDM (n=38) or T2DM (n=22); symptomatic DPN (exclusive burning pain excluded); +Tinel	DNS of peroneal (14); deep peroneal (12); tibial (31)	Sensation: descriptive 2PD NCS (performed on 70% of nerves)
Dellon (2012)^Citation25,Citation84 Prospective, consecutive, unblinded; multicenter; follow-up every 6 months up to 3.5 years (all ≥ 12 months); Delphi score: 2	DM (n=628, 465 painful) (described limbs, not cases); symptomatic DPN; +Tinel (ankle)	DNS peroneal (knee); deepperoneal (foot); four tibial tunnels (ankle); 2II of 628 had bilateral DNS	Pain: VAS Ulcer: new or recurrent Sensation: T-P, 2PD
Karagoz (2008)^Citation26 Prospective, consecutive, unblinded; singlecenter; follow-up PO day 1 and ≥6 months (mean: 8); Delphi score: I	TIDM (n= 16) or T2DM (n=8); symptomatic DPN (20/24 painful; 12/24 ulcers)	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Pain: vAS Sensation: 2PD
Knobloch (2012 abstract)^Citation27 Prospective, consecutive, unblinded; singlecenter; follow-up ≥6 months (mean: 12); Delphi score: 2/9	DM (n= 12); DPN	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Pain: vAS Ulcer: new or recurrent Sensation: (Likert) Balance: (Likert)
Lee and Dellon (2004)^Citation85 Prospective, cross-sectional, consecutive, unblinded; single-center, follow-up I2 months; Delphi score: 2	DM (n=46); symptomatic DPN, compared + or -Tinel (ankle)	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Subjective based on interview and sensation: good/excellent or poor/failure
Liao (2104)^Citation28 Retrospective; single-center (Xinhua); follow-up every 6 months for 24 months; Delphi score: 4	DM (n=306); painful DPN, focal pain (n=145) or diffuse pain (161); +Tinel Controls (n=92)	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Pain: vAS, BPI Sensation: 2PD NCS: TMA, PMA, SPA, SSC (Cv) High-resolution US: tibial CSA
Macaré van Maurik (2015)^Citation33	TIDM (n=8) or T2DM (n=30);	DNS unilateral peroneal	Pain: vAS
Prospective, consecutive, randomized (surgical side, contralateral limb control), unblinded; single-center; follow-up 3, 6, 12 months; Delphi score: 5	painful DPN; +Tinel (17% of subjects had baseline 2PD)	(knee); deep peroneal (foot); four tibial tunnels (ankle)	Sensation: T-P, 2PD
Macaré van Maurik (2015)^Citation42 Same; follow-up 12 months	TIDM (n=10) or T2DM (n=30); painful DPN;+ Tinel	Same	NCS: TMA, PMA, PMAT (amplitude, CV, distal latency)
Macaré van Maurik (2014)^Citation31 Same; follow-up mean 28 weeks (23–45 weeks); Delphi score: 4	TIDM (n=10) or T2DM (n=32); painful DPN;+ Tinel; ABI 0.8–1.15; TBI ≥0.7; +PT and DP pulses Controls (n=38)	Same	US: CSA tibial nerve; thickness of flexor retinaculum
Macaré van Maurik (2015)^Citation66 Same; follow-up 6 and I2 months; Delphi score: 4	TIDM or T2DM (n=39) painful DPN;+ Tinel	Same	Stability: quantitative sway; eyes open and closed
Nickerson^Citation46,Citation86 Retrospective; single-center; follow-up 2.5 1-13) years, extended follow-up additional 3 years,^Citation86 Delphi score: 3	DM (n=65 cases, 75 legs); DPN with previous/current ulcer; previous DNS for ulcer or neuropathic pain; palpable pulses	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Ulcer: new or recurrent
Nickerson (2014)^Citation49 Retrospective; multicenter; subset prospective cohort; follow-up 1 and 3 years; Delphi score: 3	Subset of above with painful DPN (n=42), ≥1 ulcer healed; +Tinel, ≥1 pulse, or ABI >0.8	Same	Ulcer: recurrent ipsilateral vs new ulcer contralateral control leg
Rader (2005)^Citation29 Prospective, consecutive, sensory technician blinded; single-center; follow-up 3 and 6 months; Delphi score: 3	TIDM (n=7) or T2DM (n=32) DM; (39 cases, 49 legs); painful DPN or ulceration strongly + Tinel	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle) ± neurolysis; 10 of 39 bilateral surgery	Pain: VAS Sensation: T-P, 2PD
Rozen et al (2017 abstract only)^Citation32 Prospective, consecutive, randomized (2:1 surgery [DNS vs sham] vs control), blinded subjects and evaluators; multicenter; follow-up 1, 3, 4.5 years; Delphi score: 7	DM (n=40 surgical [one or both legs] and n=27 nonsurgical controls); painful DPN	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle), with neurolysis	Pain: Likert QOL
Tekin et al (2015)^Citation44 Retrospective, unblinded; single-center; follow-up 3 months; Delphi score: 3	DM (n=27); DPN; +Tinel	DNS posterior and anterior tarsal tunnel	Doppler US: posterior tibial artery
Trignano et al (2016)^Citation45 Prospective, consecutive; unblinded; singlecenter (Italy); follow-up 18 months; Delphi score: 2	DM (n=20); DPN and concurrent bilateral tarsal tunnel syndrome; no vascular disease; +Tinel	DNS tibial nerve (ankle) (four legs had additional DNSs)	Microcirculation: transcutaneous oximetry dorsum foot
Wieman and Patel (1995)^Citation38 Prospective, consecutive; unblinded; single-center; follow-up: >2 months (mean 13 months); Delphi score: 2	DM (n=28); painful DPN; +Tinel 32 of 33 ankles; no ischemia (tibial and dorsalis pedis pulses)	DNS tibial nerve (ankle); internal neurolysis not performed	Pain: vAS Sensation: T-P; 2PD NCS: “standard studies”
Wood and Wood (2003)^Citation39 Prospective, consecutive, unblinded; single-center; follow-up >1 month (1–6, mean 3); Delphi score: 2	DM (n=33); symptomatic DPN (pain [n=30] and/or numbness); nine had NCS confirmed DPN; +Tinel; ankle/brachial index >7	DNS of peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Pain: vAS Sensation: 2PD Subjective: excellent, good, fair, or failure
Yang et al (2016)^Citation30 Prospective, consecutive, unblinded; single-center; follow-up I, 2 years; Delphi score: 2	TIDM (n=4) or T2DM (n=7) DM; painful DPN for ≥2 years; +Tinel; 2PD (great toe) >8 mm; no limb ischemia	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle)	Pain: vAS Sensation: 2PD QOL
Zhang (2013)^Citation40,Citation87 (overlapping data) Prospective, consecutive, sensory technician blinded; single-center; follow-up I8 months (ulcer follow-up: 2–5 years); Delphi score: 4	DM type 2 (n=560); DM controls without DPN (n=40); +Tinel; 2PD (great toe) >9 mm	DNS peroneal (knee); deep peroneal (foot); four tibial tunnels (ankle) with neurolysis	Ulcer: new or recurrent Sensation: 2PD, CPT, thermal NCS: TMA, PMA, SPA, SSC (Cv) US: CSA tibial and peroneal nerves TCS: symptoms and signs

Abbreviations: 2PD, two-point discrimination; A, amplitude; ABI, ankle–brachial index; BPI, brief pain inventory; CPT, cold perception threshold; CSA, cross-sectional area; CV, conduction velocity; DM, diabetes mellitus; DNS, decompression nerve surgery; DPN, distal symmetric diabetic peripheral neuropathy; NCS, nerve conduction study; PMA, peroneal motor, recording extensor digitorum brevis; PMAT, peroneal motor, recording anterior tibialis; PO, postoperative; QOL, quality of life; SSC, sural sensory, recording ankle; SPA, superficial peroneal, recording ankle; TBI, toe–brachial index; TCS, Toronto clinical scoring; TMA, tibial motor, recording abductor hallucis; T-P, touch-pressure; T1, type 1; T2, type 2; US, ultrasonography; VAS, visual analog scale.

Table 2 Assessment of bias scored as high, unclear, or low risk of bias

Author	Random sequence generation	Allocation concealment	Blinding (participant)	Blinding (observer)	Incomplete outcome data	Selective reporting	Other bias
Aszmann et al^Citation34,Citation37(duplicate)	High	High	High	Low	High	Unclear	Low
Aszmann et al^Citation50	High	High	High	High	High	Unclear	Low
Dellon^Citation41	High	High	High	High	High	Unclear	Low
Dellon et al^Citation25	High	High	High	High	High	High	Low
Dellon et al 9^Citation84	High	High	High	High	High	High	Low
Karazog et al^Citation26	High	High	High	High	High	Unclear	Low
Knobloch et al^Citation27	High	High	High	High	High	Unclear	Low
Lee and Dellon^Citation85	High	High	High	High	High	Unclear	Low
Liao et al^Citation28	High	High	High	High	High	High	Low
Macaré van Maurik et al^Citation33	Low	High	High	Low	Low	Low	Low
Macaré van Maurik et al^Citation42	Low	High	High	Low	Low	Low	Low
Macaré van Maurik et al^Citation31	Low	High	Low	High	Low	Low	Low
Macaré van Maurik et al^Citation66	Low	High	Low	High	Low	Low	Low
Nickerson^Citation46	High	High	High	High	Low	Low	Low
Nickerson^Citation86	High	High	High	High	Low	Low	Low
Nickerson and Rader^Citation49	High	High	High	High	Low	Low	Low
Rader^Citation29	High	High	High	Low	High	Lo	Low
Rozen et al^Citation32	Low	Unclear	Low	Low	Unclear	Unclear	Low
Tekin et al^Citation44	High	High	High	High	Low	Low	Low
Trignano et al^Citation45	High	High	High	High	High	Unclear	Low
Wieman and Patel^Citation38	High	High	High	High	High	Unclear	Low
Wood and Wood^Citation39	High	High	High	High	High	Unclear	Low
Yang et al^Citation30	High	High	High	High	High	Unclear	Low
Zhang^Citation40,Citation87(duplicate)	High	High	High	Low	High	Unclear	Low

Figure 1 Flow diagram of literature search results.

Table 3 Global subjective pain scores pre- and post-DNS; mean ± SD and estimated effect size (median value and range), where a positive effect size value indicates improvement

Authors	Study type	Pain scale	Limb/group	n	Pre-DNS score	Post-DNS pain score at nearest month (effect size)
						0.5	3	6	12	24	48
DNS groups
Karazog et al (2008)^Citation26	Observational	VASa	DNS	24	6.9±2.1	1.4±1.8 2.7 (2.4–3.6)		1.2±1.6 2.9 (2.6–4.0)
Knobloch et al^Citation27	Observational	VAS	DNS	12	7.1±1.2				3.3±2.4 2.0 (1.7–3.2)
Liao et al^Citation28 (diffuse pain)	Observational	VAS	DNS	161	8.3±1.8b			3.5±2.7b 2.1 (1.8–2.8)	3.0±2.8b 2.2 (1.9–3.0)	2.5±2.8b 2.5 (2.1–3.3)
Liao et al^Citation28 (focal pain)	Observational	VAS	DNS	145	8.2±1.3b			2.3±1.7b 3.9 (3.1–4.7)	2.1±1.9b 3.7 (3.2–4.9)	1.0±1.6b 4.9 (4.2–6.4)
Macaré van Maurik et al^Citation33	Randomized limb	VAS	DNS limb	38	6.1±1.9		2.8±1.3c 2.0 (1.7–2.7)	3.1±1.2 1.9 (1.6–2.5)	3.5±3.0 1.0 (0.9–1.4)
Rader^Citation29	Observational	VAS	DNS	38d	8.7±1.6	0.6±0.4 6.8 (5.1–10.5)			0.3±0.3 7.3 (5.3–11.4)
Rozen et al^Citation32	Double-blind, RCT	Likertc	DNS limb	40	~8.0e				[−5.7±2.1]f 2.7 (2.3–3.5)		[−7.5±2.5]f 3.0 (2.5–3.9)
Wood and Wood^Citation39	Observational	VAS	DNS	30	8.8±1.9		3.1±2.3 2.7 (2.3–3.5)
Yang et al^Citation30	Observational	VASg	DNS	11	7.1±1.3	4.5±1.7 17 (1.5–2.2)	3.2±1.5 2.8 (24–3.6)	2.1±1.7 3.3 (2.8–4.3)	2.0±2.0 3.0 (2.6–4.0)	1.9±2.1 3.0 (2.6–4.0)
Average pain score (average effect size)				459	8.0±1.8	1.5±1.8 4.7	3.0±1.8 2.4	2.7±2.3 2.9	2.5±2.5 3.0	1.8±2.4 3.6	[−7.5±2.5]f 3.0
Control groups/limbs
Liao et al^Citation28	Observational	VAS	Control group	92	8.0±1.2b			7.6±1.4b 0.3 (0.3–0.4)	8.0±1.1b 0.0 (0.0–0.0)	7.8±1.3b 0.2 (0.1–0.2)
Macaré van Maurik et al^Citation33	Randomized limb	VAS	Control limb	38	6.1±1.9		4.4±0.7b 1.2 (0.9–1.7)	4.6±0.6h 1.1 (0.8–1.5)	5.3±2.8 0.3 (0.3–0.4)
Rozen et al^Citation32	Double-blind, RCT	Likert	Sham limb	~20	~8.0e				[−5.3±2.8]f 1.9 (1.6–2.4)		[−6.0±2.4]f 2.5 (2.1–3.2)
Rozen et al^Citation32	Control group		Control group	~20					NS		NS
Average pain score (average effect size)				170	7.7±1.7		4.4±0.7 1.2	4.6±0.6 1.1	5.3±2.8 0.3	7.8±1.3 0.2

Notes:

a VAS pain scores based on eleven-interval analog scale (0–10);

b Liao et al mean ± SD measured from Figure 1 of their paper;

c Likert pain scores based on eleven items (0–10), with distances between each item being equal;

d results confounded by 10 of 38 participants having bilateral DNS;

e estimated using mean difference from baseline at 12 months (DNS leg, –5.72±2.71; sham leg, –5.3±2.9) and at 54 months (actual value not reported and unavailable on request);

f (mean difference ± SD) from pre-DNS minus post-DNS;

g combined daytime, nighttime, and peak pain scores, expressed on eleven-interval analog scale (0–10);

h estimated SD from 12-month data.

Abbreviations: DNS, decompression nerve surgery; RCT, randomized controlled trial; VAS, visual analog scale.

Table 4 2PD pre- and post-DNS; mean ± SD and effect size (median value and range), where positive effect size value indicates improvement

Authors	Study type	Limb/group	n	Pre-DNS (mm)	Post-DNS (mm) at the nearest month (effect size)
					3	6–12	18	24
DNS groups
Aszmann et al^Citation34	Observational	DNS	8	16.0±4.4		12.3±4.6 0.8 (0.7-1.1)
Liao et al^Citation28 (diffuse pain)	Observational	DNS	161	18.7± 1.7				7.3±1.5 7.1 (6.0-9.2)
Liao et al^Citation28 (focal pain)	Observational	DNS	145	17.4± 1.9				6.4± 1.5 6.4 (5.5-8.4)
Rader^Citation29	Observational	DNS	39	16.7	12.5	11.2
Wood and Wood^Citation39	Observational	DNS	33	18.0±2.7	12.8±4.9 1.3 (1.2-1.8)
Zhang et al^Citation40	Observational	DNS	560	9.5±2.0			6.7± 1.6 1.5 (1.3-2.0)
Average 2PD		DNS		12.8±4.6	12.8±4.9	12.3±4.6	6.7±1.6	6.9± 1.6
Average effect size					1.3	0.8	1.5	6.8
Control groups/limbs
Aszmann et al^Citation34	Observational	Control limb	8	14.3±4.8		14.1±5.1 0.0 (0.02-0.04)
Liao et al^Citation28	Observational	Control group	92	16.3±1.8				17.8± 1.7 −0.8 (0.7-1.1)

Abbreviations: 2PD, two-point discrimination; DNS, decompression nerve surgery.

Table 5 Nerve conduction study results pre- and post-DNS; mean ± SD and effect size (median value and range), where positive effect size value indicates improvement

Authors	Study type	Limb/group	n	Posterior tibial		Common peroneal		Superficial peroneal		Sural
				Pre-DNS	Post-DNS (effect size)	Pre-DNS	Post-DNS (effect size)	Pre-DNS	Post-DNS (effect size)	Pre-DNS	Post-DNS (effect size)
DNS groups
Amplitude (mV)
Macare van Maurik et al^Citation42	Randomized limb	DNS limb	40	4.7±4.0	4.1 ±3.9 −0.2 (0.1−0.2)	3.1 ±2.6	2.1 ±1.8 −0.4 (0.4−0.6)	3.0±4.9	2.3±4.5 −0.1 (0.1−0.2)
Distal latency (ms)
Macare van Maurik et al^Citation42	Randomized limb	DNS limb	40	4.3±1.4	4.5± 1.4 −0.1 (0.1−0.2)	4.3±1.1	4.7±1.2 −0.3 (0.3−0.5)
Conduction velocity (m/s)
Liao^Citation28	Observational	DNS, focal pain	145	33.5±3.1	41.8±2.6 2.9 (2.7−3.8)	37.8±3.4	42.5±2.4 1.6 (1.4–2.1)	35.8±2.5	42.2±3.1 2.3 (1.9−3.0)	37.8±3.4	43.6±2.7 1.9 (1.6−2.5)
Liao^Citation28	Observational	DNS diffuse pain	161	35.5±3.6	42.0±2.8 2.0 (1.7−2.6)	36.8±1.9	42.2±2.9 2.2 (1.9−2.9)	37.6±2.9	43.6±2.3 2.3 (2.0−3.0)	37.7±3.9	43.2±3.6 1.5 (1.2−2.9)
Macare van Maurik et al^Citation42	Randomized limb	DNS limb	40	36±1 3	37±10* 0.1 (0.1−0.1)	38±9*	37±8* −0.1 (0.1−0.1)	23±21	19±21 ’ −0.2 (0.2−0.2)
Zhang^Citation40	Observational	DNS limb	560	28.2±7.2	36.3±3.3 1.4 (1.2−2.0)	33.3±5.3	42.2±1.4 2.3 (1.7−3.4)	35.2±8.1	41.6±4.5 1.0 (0.8−1.3)	40.3±16.6a	39.7±3.1 −0.1 (0.0−0.1)
Average CV		DNS		30.7±7.3	38.2±4.5	34.2+5.1	41.9±2.8	35.2±8.3	41.1+7.6	39.4+13.6	40.8±3.5
Effect size					1.7		2.1		1.4		0.5
Control groups/limbs Amplitude (mV)
Macare van Maurik et al^Citation42	Randomized limb	Control	40	4.3±3.7	4.1 ±3.6 0.1 (0.1−0.1)	3.4±2.7	2.9±2.4 0.2 (0.2−0.2)	3.7±5.0	2.6±3.5 0.2 (0.2−0.3)
Distal latency (ms)
Macare van Maurik et al^Citation42	Randomized limb	Control	40	4.3±1.3	4.1 ±1.6 0.1 (0.1−0.2)	4.1±1.4	4.4±1.3 −0.2 (0.2−0.3)
Conduction velocity (m/s)
Liao^Citation28	Observational	Control	92	36.7±3.4	31.6±3.5 −1.5 (1.2−1.9)	33.8±2.8	28.6±3.3 −1.7(1.4−2.2)	38.6±3.7	34.4±3.6 −1.1 (1.0−1.5)	37.4±2.8	37.0±2.5 −0.2 (0.1−0.2)
Macare van Maurik et al^Citation42	Randomized limb	Control	40	36±12	35±13a −0.1 (0.1−0.1)	37±l 2	37±10a 0.0 (0.0−0.0)	22±20	21 ±21a −0.1 (0.0−0.1)
Average CV		Control	1	36.5±7.1	32.6+7.8	34.8±7.	31.1±7.2	33.6±13.7	30.3±13.4	37.4±2.8	37.0±2.5
Effect size					−1.1		−1.2		−0.8		−0.2

Note:

a The large SD is unexplained.

Abbreviations: CV, conduction velocity; DNS, decompression nerve surgery.

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