Combined Effects of Near-Infrared Light and Vibration on Diabetic Patients With Restless Leg Syndrome

Combined Effects of Near-Infrared Light and Vibration on Pain, Sleep Quality and Symptoms Severity in Diabetic Patients With Restless Leg Syndrome

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.

Restless Leg Syndrome (RLS) is a prevalent neurological sensorimotor disorder characterized by an uncontrollable urge to move the legs, often accompanied by uncomfortable sensations that worsen during rest and at night, leading to significant sleep disturbances and reduced quality of life. The condition is particularly common among individuals with diabetes, where peripheral neuropathy, poor glycemic control, and microvascular complications further exacerbate symptom severity. In Pakistan, evidence suggests a notably high prevalence of RLS in patients with type II diabetes, highlighting the clinical and public health importance of effective, context-specific management strategies. Although pharmacological treatments are commonly used, their side effects and limited long-term effectiveness emphasize the need for safe and sustainable non-pharmacological interventions.

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.

Inclusion Criteria:

Patients of age 50-65 years Both male and female patients with Type II diabetes Patients with a diagnosis of diabetes at least 6 months ago RLS (score of 11+ on the RLS scale) Patients meeting the four key RLS diagnosis criteria will be included in the study.

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:

Patients using analgesics, psychiatric, or neurological medications. Patients with any malignancies, neurological, skeletal, or vascular disorders History of drug abuse. Ongoing RLS treatments (e.g. vibration therapy, massage). Severe cognitive impairment. Pregnancy or lactation. Conditions contraindicating NIR or vibration therapy