Clinical Trials Logo

Clinical Trial Summary

Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN.


Clinical Trial Description

A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12 weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05863793
Study type Interventional
Source Shanghai University of Traditional Chinese Medicine
Contact Jian Pei, Ph.D
Phone 86-021-64385700
Email longhuaacup@aliyun.com
Status Recruiting
Phase N/A
Start date September 1, 2021
Completion date January 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04638556 - Effect of Circulating lncRNAs on Type 2 Diabetic Peripheral Neuropathy
Completed NCT05580705 - Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy N/A
Terminated NCT01620775 - MR(Magnetic Resonance) Imaging of Neurotransmitters in Chronic Pain N/A
Completed NCT02127762 - The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy N/A
Completed NCT00835757 - Diffusion Tensor Imaging of Sural Nerves in Diabetic Peripheral Neuropathy N/A
Recruiting NCT00553592 - Double Blind RCT of Bicifadine SR in Outpatients With Chronic Neuropathic Pain Associated With Diabetes Phase 2
Withdrawn NCT05041816 - Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy N/A
Recruiting NCT06074562 - A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain Phase 2
Recruiting NCT04457531 - LiuWeiLuoBi Granule for the Treatment of Diabetic Peripheral Neuropathy Early Phase 1
Completed NCT02947828 - Polyneuropathy in Diabetes Mellitus Type 2
Completed NCT02056431 - Balancing Treatment Outcomes and Medication Burden Among Patients With Symptomatic Diabetic Peripheral Neuropathy N/A
Completed NCT01681290 - Safety and Efficacy of CBX129801 in Patients With Type 1 Diabetes Phase 2
Completed NCT01474772 - Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN) Phase 3
Completed NCT01086150 - Use of Topical Lidocaine to Reduce Pain in Patients With Diabetic Neuropathy Phase 2/Phase 3
Completed NCT03447756 - Titration Study of ABX-1431 Phase 1
Completed NCT04688671 - Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain Phase 2
Completed NCT04984044 - Effect of Vitamin D in Patients With Diabetic Peripheral Neuropathy to Alleviate Pain and Improvement of Symptoms N/A
Completed NCT06130917 - Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN. N/A
Completed NCT01496365 - Treatment of Neuropathic Pain Associated With Diabetic Peripheral Neuropathy Phase 2
Completed NCT02332005 - 12-Month Efficacy and Safety of Diepalrestat in Adults With Diabetic Peripheral Neuropathy, a DB, Placebo-Controlled Study Phase 2/Phase 3