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Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome
Sponsor: Lahore University of Biological and Applied Sciences
Summary
This Randomized Clinical Trial, titled "Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptom Severity in Diabetic Patients with Restless Leg Syndrome," aims to evaluate a non-pharmacological treatment for Restless Leg Syndrome (RLS) in diabetic patients. RLS is a neurological disorder causing an irresistible urge to move the legs, and its co-occurrence with diabetes significantly worsens symptoms, pain, and sleep quality. While both Near-Infrared (NIR) light therapy and vibration therapy have individually shown benefits, this study will investigate the potential synergistic effects of combining them. 42 diabetic patients with RLS (aged 50-65) will be randomly assigned to one of three groups for four weeks (3 sessions/week): Group A (Vibration + Conventional Stretching), Group B (NIR Light + Conventional Stretching), and Group C (Combined Vibration and NIR Light + Conventional Stretching). Outcomes will be measured at baseline, 4 weeks, and 6 weeks using the International Restless Leg Syndrome Rating Scale (IRLS), the Pittsburgh Sleep Quality Index (PSQI), and the Numeric Pain Rating Scale (NPRS). This research explores the synergistic effects of near-infrared light and vibration therapy on Restless Leg Syndrome (RLS) symptoms in diabetic patients, aiming to alleviate symptoms, improve sleep quality, and enhance overall well-being.
Official title: Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptoms Severity in Diabetic Patients With Restless Leg Syndrome
Key Details
Gender
All
Age Range
50 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2025-12-14
Completion Date
2026-05
Last Updated
2025-12-29
Healthy Volunteers
No
Conditions
Interventions
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.