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Peripheral nerve decompression for painful diabetic peripheral neuropathy in lower extremities: a single-center, open-label randomized controlled trial

Peripheral nerve decompression for painful diabetic peripheral neuropathy in lower extremities: a single-center, open-label randomized controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050049
Enrollment
Unknown
Registered
2021-08-16
Start date
2022-02-01
Completion date
Unknown
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic peripheral neuropathy

Interventions

Medication group:Step medication treatment
Nerve decompression combined with step medication treatment group:Nerve decompression combined with step medication treatment

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. According to the 1999 WHO diagnostic criteria for type 2 diabetes, aged 40 to 70 years old; 2. Michigan Diabetes Peripheral Nerve Screening (MNSI) score > 2; 3. The hypoglycemic regimen is stable, maintaining fasting blood glucose 4 points, difference 4 points; 5. There are positive Tinel signs on both sides, including but not limited to the following sites: the lateral peroneal canal of the knee (common peroneal nerve), the medial tarsal canal (posterior tibial nerve) and between the first and second metatarsal bones anterior (deep peroneal nerve); 6. Nerve electrophysiology indicates that there is more than one nerve (common peroneal nerve, posterior tibial nerve and deep peroneal nerve) in both lower extremities with slow conduction velocity (>=2 standard deviations), which may be accompanied by decreased amplitude.

Exclusion criteria

Exclusion criteria: 1. Combined with other injuries or history of drug use that may lead to peripheral neuropathy, such as pernicious anemia, hypothyroidism, lower extremity vascular disease (disappearance or weakening of dorsal foot artery fluctuations, varicose veins, etc.); history of lower extremity trauma or surgery; History of drug use such as vincristine, phenytoin; history of heavy metal poisoning, etc.; 2. There is a history of alcohol or drug addiction and abuse within 1 year of enrollment; 3. Lumbar stenosis or discogenic neuropathy; 4. Lower extremity edema caused by various reasons; 5. Patients with severe bleeding disorders or bleeding tendency; 6. Those with heart, lung, liver, kidney and other organ dysfunction that cannot tolerate surgery or drugs; 7. Patients with mental disorders and other factors that affect compliance; 8. Rheumatism and rheumatoid diseases, etc.; 9. Patients who are participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
average visual analogue score within one week;

Secondary

MeasureTime frame
two-point discrimination;Scoreof use of analgesic drug;Toronto score;nerve conduction velocity;hospital anxiety and depression score;SF-36 Quality of Life Scale Assessment;neuropathic pain;

Countries

China

Contacts

Public ContactLiao Chenlong, Zhang Wenchuan

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Leoliao11@163.com+86 18817821520

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026