Laser acupuncture for diabetic peripheral neuropathy

The Efficacy of Laser Acupuncture on the Diabetes-induced Peripheral Neuropathy: Basic and Clinical Research

This study is testing if laser acupuncture can help people with diabetic peripheral neuropathy feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Taiwan Municipal An-Nan Hospital-China Medical University (Academic / other)
• Locations: 1 site (Tainan)
• Trial ID: NCT05921019 on ClinicalTrials.gov

What this trial studies

This pilot, single-center, randomized controlled trial aims to evaluate the effects of laser acupuncture on patients suffering from diabetic peripheral neuropathy (DPN). A total of 30 eligible participants will be randomly assigned to either a laser acupuncture group or a sham laser acupuncture group, with each participant receiving 24 interventions over 8 weeks. The study will assess clinical outcomes using standardized measures to determine the efficacy of laser acupuncture in alleviating symptoms associated with DPN. The trial will be conducted at Tainan Municipal An-Nan Hospital in Taiwan, ensuring rigorous methodology and ethical oversight.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 years old with type II diabetes who exhibit symptoms and signs of diabetic neuropathy.

Not a fit: Patients with severe diabetic peripheral neuropathy causing muscular weakness or those with neuropathy from other causes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide significant relief from the painful symptoms of diabetic peripheral neuropathy.

How similar studies have performed: While there is limited data on laser acupuncture specifically for DPN, similar approaches in acupuncture have shown promise in treating neuropathic pain.

Eligibility criteria

Inclusion Criteria:

1. female or male patients (aged over 18 years) with diabetes mellitus type II.
2. patients have symptoms (numbness, tingling, burning, stabbing, shooting pain, etc.) and signs (symmetric decreased distal sensation, or decreased or absent ankle reflexes) of diabetic neuropathy.
3. presence of abnormal nerve conduction study, or presence of neuropathy is likely tested by Semmes-Weinstein 10-g monofilament, or decreased vibration sensation tested by 128Hz vibration tuning fork
4. patients who have completed titration of pain medication or stopped accepting physical therapy against DPN;
5. must provide written informed consent.

Exclusion Criteria:

1. severe DPN with muscular weakness of the proximal leg muscles;
2. neuropathy due to other reasons (such as HIVD, malignancy, severe renal disease, hepatitis, thyroid disease, vitamine B12 deficiency, virus infection (such as: human immunodeficiency virus infection, etc), syphilis, alcohol, neurotoxic drug use, inflammatory disease (such as chronic inflammatory demyelinating polyneuropathy), heavy metal intoxication, hereditary disease, etc)
3. severe peripheral artery disease in Fontaine stage IV(Focal tissue necrosis, ulceration or gangrene);
4. traumatic lesions of the nerves or vessels in the lower extremities;
5. opioid use before inclusion in the study;
6. regular use of cannabis or cannabinoids;
7. severe mental illness;
8. severe impairment of cognitive function;
9. pregnancy or lactation
10. obesity (BMI\>35 kg/m2)

Where this trial is running

Tainan

• Tainan Municipal An Nan Hospital-China Medical University — Tainan, Taiwan (Recruiting)

Study contacts

• Principal investigator: Yi-Hung Chen, PhD — China Medical University, China
• Study coordinator: Chien-Chen Huang, PhD

Conditions Diabetic Peripheral Neuropathy; diabetic peripheral neuropathy; laser acupuncture