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Laser Acupuncture on Diabetes-induced Peripheral Neuropathy

NCT05921019 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-06-27

No results posted yet for this study

Summary

Diabetic peripheral neuropathy (DPN) is one of the microvascular complications of diabetes mellitus. This can lead to painful and costly clinical sequelae such as foot ulcers, amputation, and neuropathic pain. There are several novel diagnostic methods available for complementary to clinical assessment and may help in the early detection of DPN. However, treatments for DPN and painful DPN are limited.

We will conduct a pilot, single-center, randomized controlled trial in patients with DPN to verify the effect of the laser acupuncture on DPN. With designed inclusion and exclusion criteria, 30 eligible participants will be randomized with 1:1 allocation ratio to the following two groups:(1) the laser acupuncture group (N=15), (2) the sham laser acupuncture group (N=15). Each participant will receive 24 interventions within 8 weeks, three times per week. Participants follow the laser acupuncture protocol in our study. All participants will be clinically assessed by (1) Michigan Neuropathy Screening Instrument (MNSI), (2) questionnaires (BPI(SF)-DPN) for diabetic neuropathic pain assessment, and (3) nerve conduction test.

This research project will validate our novel preliminary findings demonstrating neuroprotective effects of laser acupuncture treatment. Importantly, our data are expected to elucidate how laser acupuncture induces neuroprotection in the clinical setting and provide a scientific base for developing new approaches in the treatment of DPN.

Conditions

  • Diabetic Peripheral Neuropathy

Interventions

DEVICE

laser acupuncture

This study will use the Handylaser Trion laser manufactured by RJ Laser, Germany.

DEVICE

sham laser acupuncture

This study will use the sham Handylaser Trion laser manufactured by RJ Laser, Germany,and without any laser beam delivering

Sponsors & Collaborators

  • Taiwan Municipal An-Nan Hospital-China Medical University

    lead OTHER

Principal Investigators

  • Yi-Hung Chen, PhD · China Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05921019 on ClinicalTrials.gov