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ACTIVE NOT RECRUITING
NCT07613489
NA

Photobiomodulation for Diabetic Peripheral Neuropathy

Sponsor: University of Faisalabad

View on ClinicalTrials.gov

Summary

Diabetic peripheral neuropathy (DPN) is a common complication of long-term diabetes, affecting approximately 50 percent of patients. It causes tingling, numbness, and burning pain primarily in the feet, which reduces quality of life. Photobiomodulation therapy (PBMT), also known as low-level laser therapy, is a non-invasive treatment that may improve nerve function by reducing inflammation and promoting cellular repair. This randomized controlled trial aims to evaluate the effectiveness of PBMT in improving nerve function and quality of life in patients with DPN. A total of 36 participants with type 2 diabetes and DPN will be randomly assigned to either a treatment group receiving PBMT (900 nm wavelength, 25W, 1000 Hz frequency) or a control group receiving sham laser therapy. The intervention will be applied to the dorsum and plantar surface of the foot every other day for 6 weeks. Outcomes include pain intensity measured by the Numeric Pain Rating Scale, Neuropathic pain measured by Leeds Assessment of Neuropathic symptoms and signs scale, Nerve function measured by Michigan Neuropathy Screening Instrument and quality of life measured by the NORFOLK QOL DN questionnaire, assessed at baseline and after the intervention period.

Official title: Effectiveness of Photobiomodulation Therapy in Enhancing Nerve Function and Quality of Life Among Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2026-02-01

Completion Date

2026-06-24

Last Updated

2026-06-23

Healthy Volunteers

No

Interventions

DEVICE

Photobiomodulation Therapy

Photobiomodulation therapy (PBMT) was delivered using an infrared light therapy device with 3 x 808 nm and 12 x 650 nm multi-speed modes with pulse function. The device parameters were: wavelength of 900 nm, power of 25W, and frequency of 1000 Hz in pulse mode. The therapy was applied to the dorsum and plantar surface of the foot for 9 minutes per session. Treatment was administered every other day for 2 weeks, resulting in a total of 7 sessions per participant. The intervention was delivered by a trained physiotherapist in a clinical setting at MoveBetter Clinic, Faisalabad, Pakistan. Participants remained in a comfortable seated position with the foot exposed during treatment. Safety goggles were provided to both the participant and the therapist.

DEVICE

Sham Laser Therapy

Sham laser therapy was delivered using the same infrared light therapy device as the active treatment, with the laser deactivated. The device was positioned and handled identically to the active treatment, and the same auditory signals were produced to maintain blinding of participants. The same procedure was followed: application to the dorsum and plantar surface of the foot for 9 minutes per session, every other day for 2 weeks (total of 7 sessions). Participants were unaware of their group assignment throughout the study period. The sham intervention was delivered by the same trained physiotherapist in the same clinical setting at MoveBetter Clinic, Faisalabad, Pakistan.

Locations (1)

The University of Faisalabad

Faisalābad, Punjab Province, Pakistan