Surgical peripheral nerve decompression for the treatment of painful diabetic neuropathy of the foot – A level 1 pragmatic randomized controlled trial

Best, Timothy J.; Best, Corliss; BEST, A.; Fera, Luke A.

doi:10.1016/j.diabres.2018.08.002

Cited by 18 publications

(13 citation statements)

References 39 publications

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“…66,69 Surgical decompression significantly improved pain 66,69 but data on whether it would also improve quality of life are conflicting. 67,69…”

Section: Discussionmentioning

confidence: 99%

“…73 Since then, large observational studies and small RCTs have provided evidence to suggest that surgical decompression of peripheral nerves in the lower extremity can be considered in patients with PDN and superimposed compression of specific peripheral nerves. 66,69 Surgical decompression significantly improved pain 66,69 but data on whether it would also improve quality of life are conflicting. 67,69 PDN pain might be sympathetically maintained in some patients, 81 so that lumbar sympathetic block or neurolysis may provide pain relief in the lower extremities.…”

Section: Discussionmentioning

confidence: 99%

“…66,69 Surgical decompression significantly improved pain 66,69 but data on whether it would also improve quality of life are conflicting. 67,69 PDN pain might be sympathetically maintained in some patients, 81 so that lumbar sympathetic block or neurolysis may provide pain relief in the lower extremities. 38 The sympathetic block could be a viable option for patients with refractory PDN.…”

Section: Discussionmentioning

confidence: 99%

See 2 more Smart Citations

Advances in Interventional Therapies for Painful Diabetic Neuropathy: A Systematic Review

Sun

Casserly³

et al. 2022

Anesthesia &Amp; Analgesia

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BACKGROUND: Painful diabetic neuropathy (PDN) is one of the major complications of diabetes mellitus. It is often debilitating and refractory to pharmaceutical therapies. Our goal was to systematically review and evaluate the strength of evidence of interventional management options for PDN and make evidence-based recommendations for clinical practice. METHODS: We searched PubMed, Scopus, Google Scholar, and Cochrane Llibrary and systematically reviewed all types of clinical studies on interventional management modalities for PDN. RESULTS: We identified and analyzed 10 relevant randomized clinical trials (RCTs), 8 systematic reviews/meta-analyses, and 5 observational studies of interventional modalities for PDN using pain as primary outcome. We assessed the risk of bias in grading of evidence and found that there is moderate to strong evidence to support the use of dorsal column spinal cord stimulation (SCS) in treating PDN in the lower extremities (evidence level: 1B+), while studies investigating its efficacy in the upper extremities are lacking. Evidence exists that acupuncture and injection of botulinum toxin-A provide relief in pain or muscle cramps due to PDN with minimal side effects (2B+/1B+). Similar level of evidence supports surgical decompression of lower limb peripheral nerves in patients with intractable PDN and superimposed nerve compression (2B±/1B+). Evidence for sympathetic blocks or neurolysis and dorsal root ganglion (DRG) stimulation is limited to case series (2C+). CONCLUSIONS: Moderate to strong evidence exists to support the use of SCS in managing lower extremity pain in patients who have failed conventional medical management for PDN. Acupuncture or injection of botulinum toxin-A can be considered as an adjunctive therapy for PDN. Surgical decompression of peripheral nerves may be considered in patients with PDN superimposed with nerve compression. High-quality studies are warranted to further evaluate the safety, efficacy, and cost-effectiveness of interventional therapies for PDN. (Anesth Analg 2022;134:1215-28) KEY POINTS• Question: What options are available to manage patients with painful diabetic neuropathy (PDN) beyond pharmaceutical therapies? • Findings: Emerging evidence indicates that interventional therapies such as spinal cord stimulation (SCS), acupuncture, botulinum toxin A injection, and surgical decompression of lower limb peripheral nerves can provide clinically meaningful pain relief in patients with refractory PDN. • Meaning: When PDN is refractory to pharmaceutical therapies, clinician should explore interventional management options.

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“…66,69 Surgical decompression significantly improved pain 66,69 but data on whether it would also improve quality of life are conflicting. 67,69…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Advances in Interventional Therapies for Painful Diabetic Neuropathy: A Systematic Review

Sun

Casserly³

et al. 2022

Anesthesia &Amp; Analgesia

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“…9 In 1992, Dellon first proposed peripheral nerve decompression (PND) in the tarsal tunnel to treat DSPN with 85% improvement of the symptoms, normalization of Tinel's sign and nerve conduction studies. 10 Since then many publications, including randomized controlled trials 1,11,12 have shown that nerve decompression improves sensory function of the foot in more than 80% of cases, relieves the pain, prevents formation of DFU and its subsequent complications like amputations. 10, 13e16 But the idea of PND for DSPN has not met with widespread acceptance; mainly because of two reasons: 1) The skeptics refuse to believe in benefits of surgical treatment for a metabolic disease, 17 as immediate pain relief, bilateral pain relief after unilateral surgery, and large number of patients getting relief were considered too good to be true.…”

Section: Discussionmentioning

confidence: 99%

Tarsal tunnel release restores sensations in sole for diabetic sensorimotor polyneuropathy

Agarwal

Sharma

2020

Journal of Clinical Orthopaedics and Trauma

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Background: Diabetic sensorimotor polyneuropathy (DSPN) is the commonest form of neuropathy. Loss of sensations in sole leads to diabetic foot ulcers (DFU) and its complications. Surgical decompression has been used in the treatment of diabetic peripheral neuropathy, however; its effectiveness has been questioned. Purpose of this study was to evaluate the sensory recovery in sole after tarsal tunnel decompression (TTD) in patients having DSPN. Methods: Thirteen patients (Age28-70 years, average 35.57 years; 7 Males, 6 Females; 20 feet) with DSPN and positive Tinel's sign over the tarsal tunnel were included in the study. Pre and post-operative sensory tests performed on the sole included tests for touch, pain, temperature, pressure, vibration perception threshold (VPT) and two-point discrimination (2-PD). Results were classified as per British Medical Research Council (MRC) scoring system. Results: eSixteen feet were followed-up for 6 months. In all feet perception of touch, pain and pressure recovered. Temperature perception recovered in 75% feet. VPT came to normal range (16.81V) from 40.37 V and 2-PD came down to average of 6.0 mm from preoperative average of11.2 mm.MRC scale improved from S0 in 5 feet and S2 in 15 feet to S 3þ in all 16 feet.There were no ulcers or amputation in operated limbs during follow up period of 6 months. Conclusions: TTD improves plantar sensations in diabetic neuropathy and prevents ulcers and its related complications.

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“…13 14 However, no high-quality real-world data exist in which lower extremity nerve decompression (LEND) surgery is compared with conventional, non-surgical care in the diabetic neuropathy population. [15][16][17] Since conventional non-surgical care for the patient with neuropathy outnumbers current practices compared with surgical management of entrapped lower extremity nerves, but the latter having increasingly positive evidence, it is meaningful to further investigate differences in outcomes in a randomised controlled setting.…”

Section: Introductionmentioning

confidence: 99%

(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial—study protocol for a randomised controlled trial

et al. 2020

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IntroductionThe peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care.Methods and analysisA stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment. Primary outcome: disease-specific quality of life (Norfolk Quality of Life Questionnaire—Diabetic Neuropathy). Secondary outcomes: health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model.Ethics and disseminationEthics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences.Trial registration numberNetherlandsTrial Registry NL7664.

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Surgical peripheral nerve decompression for the treatment of painful diabetic neuropathy of the foot – A level 1 pragmatic randomized controlled trial

Cited by 18 publications

References 39 publications

Advances in Interventional Therapies for Painful Diabetic Neuropathy: A Systematic Review

Advances in Interventional Therapies for Painful Diabetic Neuropathy: A Systematic Review

Tarsal tunnel release restores sensations in sole for diabetic sensorimotor polyneuropathy

(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial—study protocol for a randomised controlled trial

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