Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome
NCT ID: NCT07308080
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
42 participants
INTERVENTIONAL
2025-12-14
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recent advances in physical therapy and rehabilitative care have increasingly focused on non-invasive sensory and neuromodulatory approaches to manage RLS symptoms. Near-infrared (NIR) light therapy and vibration therapy have independently demonstrated beneficial effects in reducing pain, improving peripheral circulation, decreasing symptom severity, and enhancing sleep quality in patients with RLS. However, existing studies are limited by small sample sizes, heterogeneous protocols, and a lack of long-term follow-up, particularly in diabetic populations. Importantly, despite encouraging individual results, the combined therapeutic effects of NIR light and vibration have not yet been systematically explored in diabetic patients with RLS, representing a significant gap in current rehabilitation research.
This randomized clinical trial aims to investigate the combined effects of near-infrared light and vibration therapy on pain intensity, sleep quality, and symptom severity in diabetic patients diagnosed with Restless Leg Syndrome. Participants meeting established diagnostic criteria will be recruited from multiple clinical settings and randomly allocated into three groups: vibration therapy with conventional stretching exercises, near-infrared light therapy with conventional stretching exercises, and a combined intervention group receiving both vibration and NIR therapy alongside conventional physiotherapy. Outcomes will be assessed at baseline, post-intervention, and follow-up using validated tools including the International Restless Legs Syndrome Rating Scale, Pittsburgh Sleep Quality Index, and Numeric Pain Rating Scale.
The findings of this study are expected to provide clinically meaningful evidence regarding the effectiveness of combined vibration and near-infrared light therapy as a non-pharmacological treatment approach for RLS in diabetic patients. By addressing pain, sleep disturbances, and symptom severity simultaneously, this combined intervention may offer a safer and more effective alternative to medication-dependent management. The results have the potential to inform clinical practice, support patient-centered rehabilitation strategies, and improve overall quality of life for individuals living with diabetes and Restless Leg Syndrome, particularly in resource-limited healthcare settings.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A( Vibration Therapy + Conventional Physical Therapy)
Participants allocated to this group will receive vibration therapy in addition to conventional physical therapy. Localized vibration will be applied to the calf muscles using a low-voltage vibration device for 10 minutes during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen comprising a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.
Vibration
Vibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks.
Conventional Physical Therapy
The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.
Group B (Near-Infrared Light + Conventional Physical Therapy)
Participants allocated to this group will receive near-infrared (NIR) light therapy in addition to conventional physiotherapy. Near-infrared light will be applied to the lower limbs for 10 minutes during supervised rehabilitation sessions using a standardized therapeutic device. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.
Near-Infrared Light Therapy
The Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks.
Conventional Physical Therapy
The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.
Group C ( (Infrared light + Vibration and Conventional Therapy)
Participants allocated to this group will receive combined near-infrared (NIR) light therapy and vibration therapy in addition to conventional physiotherapy. Near-infrared light therapy will be applied to the lower limbs for 10 minutes using a standardized therapeutic device, followed by localized vibration therapy applied to the calf muscles for 10 minutes using a low-voltage vibration device during supervised rehabilitation sessions. The conventional physiotherapy program will follow standard rehabilitation protocols and will include a structured stretching regimen consisting of a 5-minute warm-up, 20 minutes of lower-limb stretching exercises, and a 5-minute cool-down.
Near-Infrared Light Therapy
The Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks.
Vibration
Vibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks.
Conventional Physical Therapy
The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Near-Infrared Light Therapy
The Near-infrared light therapy will be applied under the supervision of a qualified physiotherapist. Near-infrared light therapy involves the application of infrared lamps to the lower limbs to improve blood flow, reduce inflammation, and modulate neural activity associated with Restless Leg Syndrome symptoms. Participants in this group will receive NIR therapy for 10 minutes per session as part of the combined intervention. The intervention will be delivered three times per week for a total duration of 4 weeks.
Vibration
Vibration therapy will be delivered using a low-voltage vibration device applied to the calf muscles. The therapy is intended to stimulate sensory receptors, improve neuromuscular function, and reduce symptom severity. Participants will receive vibration therapy for 10 minutes per session. The intervention will be delivered three times per week for a total duration of 4 weeks.
Conventional Physical Therapy
The stretching program will be 30 minutes long, starting with a 5-minute warm-up, followed by 20 minutes of stretching exercises. The exercises will include hip rotation, quadriceps stretch, knee to chest stretch, hamstring stretch, gluteal stretch, straight leg raise, and side-lying leg lift. Each stretch will be held for 5 seconds and repeated for 3 sets of 10 repetitions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Criterion is: Urge to move due to uncomfortable leg sensations, symptoms worsening at rest, symptoms relief with movement ,greater symptom severity in the evening or at night.
Willingness to provide informed consent .
Exclusion Criteria
50 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Lahore University of Biological and Applied Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Ratnani G, Harjpal P. Advancements in Restless Leg Syndrome Management: A Review of Physiotherapeutic Modalities and Their Efficacy. Cureus. 2023 Oct 10;15(10):e46779. doi: 10.7759/cureus.46779. eCollection 2023 Oct.
Ning P, Mu X, Yang X, Li T, Xu Y. Prevalence of restless legs syndrome in people with diabetes mellitus: A pooling analysis of observational studies. EClinicalMedicine. 2022 Mar 24;46:101357. doi: 10.1016/j.eclinm.2022.101357. eCollection 2022 Apr.
Coban O, Un Yildirim N, Yasa ME, Sonkaya AR. Effects of Different Exercise Programs on Symptoms, Sleep, and Quality of Life in Patients with Primary Restless Legs Syndrome. Mov Disord Clin Pract. 2023 Jul 27;10(9):1349-1359. doi: 10.1002/mdc3.13833. eCollection 2023 Sep.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UBAS/ERB/FoRS/25/038
Identifier Type: -
Identifier Source: org_study_id