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Photobiomodulation for Diabetic Peripheral Neuropathy (PBMT-DPN)

2026年6月14日 更新者：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.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (实际的)

36

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 巴基斯坦
    • Punjab Province
      • Faisalābad、Punjab Province、巴基斯坦、3800
        • The University of Faisalabad

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.
设备：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.
假比较器：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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Pain Intensity
大体时间：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)

次要结果测量

结果测量
措施说明
大体时间
Change in Quality of Life
大体时间：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
大体时间：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)

其他结果措施

结果测量
措施说明
大体时间
Change in Neuropathy Screening Status
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Faisalabad

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月1日

初级完成 (估计的)

2026年6月24日

研究完成 (估计的)

2026年6月24日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年6月17日

上次提交的符合 QC 标准的更新

2026年6月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TUF/EIRB/ 201 /26

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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