PBMT-DPN
Effectiveness of Photobiomodulation Therapy in Enhancing Nerve Function and Quality of Life Among Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Trial
Sponsor study identifier
interventional
36
1 country
1
Study Start
February 1, 2026
Actual (reported)Primary Completion
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2026
Actual (reported)May 21, 2026
Actual (reported)May 29, 2026
Actual (reported)June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
Change in Quality of Life
Baseline and Week 2 (post-intervention)
Change in Neuropathic Pain Characteristics
Baseline and Week 2 (post-intervention)
Change in Neuropathy Screening Status
Baseline only (screening)
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.
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.
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.
The University of Faisalabad
Faisalābad, Punjab Province, 3800, Pakistan
36 participants (actual enrollment reported by the registry).
First Submitted
May 21, 2026
First Posted
May 29, 2026
Study Start
February 1, 2026
Actual (reported)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.
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Primary Completion
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 23, 2026
Record last verified: 2026-06
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