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Photobiomodulation for Diabetic Peripheral Neuropathy (PBMT-DPN)

14 de junio de 2026 actualizado por: Anbreena Rasool, University of Faisalabad

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

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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

This study is a randomized, double-blind, sham-controlled clinical trial. Participants will be enrolled from Move Better Clinic and Madinah Teaching Hospital in Faisalabad, Pakistan.

Randomization and allocation concealment: Eligible participants will be randomly assigned in a 1:1 ratio to either the photobiomodulation therapy group or the sham laser group. Randomization will be performed using a computer-generated random number table. Allocation will be concealed in sequentially numbered, opaque, sealed envelopes that will be opened only after baseline assessment.

Blinding: Participants will be blinded to their group assignment because both groups will undergo the same procedure with the same device; only the experimental group will receive active laser. Outcome assessments will be performed by a physiotherapist who remains blinded to group assignment. The therapist delivering the intervention cannot be blinded, but all data entry and statistical analysis will be performed using coded group identifiers.

Sample size calculation: Sample size of 36 participants (18 per group) was calculated using Rao Software based on a previous study by Suganthirababu et al. (2018), assuming a power of 80% and alpha of 0.05.

Statistical analysis: Data will be analyzed using IBM SPSS software. Normality of data distribution will be tested using the Shapiro-Wilk test. For normally distributed data, within-group differences will be analyzed using paired t-tests, and between-group differences will be analyzed using independent t-tests. For non-normally distributed data, appropriate non-parametric tests (Wilcoxon signed-rank and Mann-Whitney U) will be used. A p-value less than 0.05 will be considered statistically significant.

Tipo de estudio

Intervencionista

Inscripción (Actual)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Pakistán
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistán, 3800
        • The University of Faisalabad

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Photobiomodulation Therapy Group
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.
Dispositivo: 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.
Dispositivo: 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.
Comparador falso: Sham Laser Therapy Group
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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Pain Intensity
Periodo de tiempo: Baseline and Week 2 (post-intervention)
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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Quality of Life
Periodo de tiempo: Baseline and Week 2 (post-intervention)
Quality of life was measured using the SF-36 questionnaire, a 36-item validated instrument assessing physical and mental health across eight domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Domain scores range from 0 to 100, with higher scores indicating better quality of life.
Baseline and Week 2 (post-intervention)
Change in Neuropathic Pain Characteristics
Periodo de tiempo: Baseline and Week 2 (post-intervention)
Neuropathic pain characteristics were assessed using the LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale. The LANSS scale includes sensory descriptions and bedside sensory testing (allodynia and altered pin-prick threshold). Total scores range from 0 to 24. Scores of 12 or greater indicate that neuropathic mechanisms are likely contributing to the patient's pain.
Baseline and Week 2 (post-intervention)

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Neuropathy Screening Status
Periodo de tiempo: Baseline only (screening)
Neuropathy status was assessed using the Michigan Neuropathy Screening Instrument (MNSI), which includes a 15-item questionnaire and a brief physical examination of the feet. This measure was used for screening and descriptive purposes rather than as a primary or secondary efficacy outcome.
Baseline only (screening)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Faisalabad

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de febrero de 2026

Finalización primaria (Estimado)

24 de junio de 2026

Finalización del estudio (Estimado)

24 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

29 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

17 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

14 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TUF/EIRB/ 201 /26

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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