Acupuncture for diabetic peripheral neuropathy: study protocol for a randomized, placebo-controlled trial

Area of Science:

• Neurology
• Integrative Medicine
• Clinical Trials

Background:

• Diabetic peripheral neuropathy (DPN) is a common diabetes complication impacting quality of life.
• Effective therapeutic strategies for DPN are limited.
• Acupuncture is explored as a potential treatment for DPN.

Purpose of the Study:

• To determine the efficacy and safety of manual acupuncture (MA) compared to sham acupuncture (SA) for DPN.
• To evaluate the impact of MA on nerve conduction and clinical outcomes in DPN patients.

Main Methods:

• A randomized, placebo-controlled clinical trial involving 118 DPN patients.
• Participants receive 24 sessions of either MA or SA over 12 weeks.
• Primary outcome: peroneal motor nerve conduction velocity; Secondary outcomes: nerve function, glucose control, quality of life, and safety assessments.

Main Results:

• Primary outcome: peroneal motor nerve conduction velocity at week 12 compared to baseline.
• Secondary outcomes include nerve conduction parameters, blood glucose levels (FPG, 2hPG, HbA1c), and patient-reported outcomes (MNSI, DSQL).
• Safety and masking effectiveness will also be assessed.

Conclusions:

• This trial aims to provide high-quality evidence on the efficacy and safety of MA for DPN.
• Results will inform clinical practice and future research in DPN management.
• Findings will be published in peer-reviewed journals.