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.
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Parallel
Near-Infrared Light Therapy
Other interventionThe 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
Other interventionVibration 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
BehavioralThe 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.
International Restless Legs Syndrome Rating Scale (IRLS)
Severity of Restless Leg Syndrome symptoms will be assessed using the International Restless Legs Syndrome Rating Scale (IRLS), a validated 10-item questionnaire designed to evaluate symptom severity and impact on daily life. Each item is scored on a 5-point Likert scale, with total scores ranging from 0 to 40, where higher scores indicate greater symptom severity. Improvement will be defined as a reduction in IRLS total scores following the intervention.
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI), a standardized 19-item self-report questionnaire assessing sleep quality and disturbances over the previous month. The global PSQI score ranges from 0 to 21, with higher scores indicating poorer sleep quality. Improvement will be defined as a reduction in PSQI global scores following the intervention period.
Numeric Pain Rating Scale (NPRS)
Pain intensity associated with Restless Leg Syndrome will be evaluated using the Numeric Pain Rating Scale (NPRS). Participants will rate their pain on a scale from 0 (no pain) to 10 (worst imaginable pain). Improvement will be defined as a decrease in NPRS scores after completion of the intervention.
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