Photobiomodulation for Diabetic Peripheral Neuropathy

NCT07613489 | Active Not Recruiting

• 1 other identifier: TUF/EIRB/ 201 /26
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 two weeks. Outcomes include pain intensity measured by the Numeric Pain Rating Scale and quality of life measured by the SF-36 questionnaire, assessed at baseline and after the intervention period.

Conditions

Diabetic Peripheral Neuropathy; Diabetes Mellitus Type 2

Keywords

Photobiomodulation, Low-Level Laser Therapy, Diabetic Neuropathy, Quality of Life, Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity

  Pain intensity was measured using the Numeric Pain Rating Scale (NPRS), an 11-point scale ranging from 0 (no pain) to 10 (worst possible pain). Participants were asked to rate their current level of foot pain at each assessment point. Higher scores indicate greater pain intensity. The change from baseline to post-intervention was calculated for each participant.

  Baseline and Week 2 (post-intervention)

Secondary Outcomes (2)

• Change in Quality of Life

  Baseline and Week 2 (post-intervention)

• Change in Neuropathic Pain Characteristics

  Baseline and Week 2 (post-intervention)

Other Outcomes (1)

• Change in Neuropathy Screening Status

  Baseline only (screening)

Study Arms (2)

Photobiomodulation Therapy Group

EXPERIMENTAL

Photobiomodulation therapy (PBMT) was delivered using a device with 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 Aziz Fatima Hospital and Madinah Teaching Hospital, 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: Photobiomodulation Therapy; Device: Sham Laser Therapy

Sham Laser Therapy Group

SHAM COMPARATOR

Sham laser therapy was delivered using the same device as the experimental group, with the laser deactivated. 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). The device was positioned and handled identically to the active treatment, and the same auditory signals were produced to maintain blinding of participants. Participants were unaware of their group assignment throughout the study period.

Device: Sham Laser Therapy

Interventions

Photobiomodulation Therapy DEVICE

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.

Photobiomodulation Therapy Group

Sham Laser Therapy DEVICE

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.

Photobiomodulation Therapy Group; Sham Laser Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of type 2 diabetes mellitus
• Diagnosis of diabetic peripheral neuropathy
• Age 18 years or older
• Male and female participants
• Pain duration of 6 months or more
• Numeric Pain Rating Scale (NPRS) score of 3 or greater out of 10 at baseline
• No acute infections at the time of enrollment

You may not qualify if:

• Skin lesions, infections, or ulcers in the treatment area
• Severe heart disease or kidney dysfunction
• Mental illness or malignant tumors
• Presence of pacemaker or implanted electrical device
• Chronic alcohol or drug abuse
• Patients unwilling to provide informed consent
• Pregnancy
• Post-surgical cases (heart or brain surgery) within 30 days
• History of stroke

Sponsors & Collaborators

• University of Faisalabad: lead

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Neuropathies; Neuralgia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 24, 2026
• Study Completion (Estimated): June 24, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)