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

NCT07308080 | Not Yet Recruiting DMC

• 1 other identifier: UBAS/ERB/FoRS/25/038
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Restless Leg Syndrome (RLS)

Keywords

RLS, Diabetic patient, Near-Infrared Light, Vibration, Pain, Sleep Quality

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline, at 4th week, after 6th week

• 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.

  Baseline, at 4th week, after 6th week

• 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.

  Baseline, at 4th week, after 6th week

Study Arms (3)

Group A( Vibration Therapy + Conventional Physical Therapy)

EXPERIMENTAL

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.

Other: Vibration; Behavioral: Conventional Physical Therapy

Group B (Near-Infrared Light + Conventional Physical Therapy)

EXPERIMENTAL

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.

Other: Near-Infrared Light Therapy; Behavioral: Conventional Physical Therapy

Group C ( (Infrared light + Vibration and Conventional Therapy)

EXPERIMENTAL

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.

Other: Near-Infrared Light Therapy; Other: Vibration; Behavioral: Conventional Physical Therapy

Interventions

Near-Infrared Light Therapy OTHER

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.

Group B (Near-Infrared Light + Conventional Physical Therapy); Group C ( (Infrared light + Vibration and Conventional Therapy)

Vibration OTHER

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.

Group A( Vibration Therapy + Conventional Physical Therapy); Group C ( (Infrared light + Vibration and Conventional Therapy)

Conventional Physical Therapy BEHAVIORAL

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 A( Vibration Therapy + Conventional Physical Therapy); Group B (Near-Infrared Light + Conventional Physical Therapy); Group C ( (Infrared light + Vibration and Conventional Therapy)

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Related Publications (3)

• 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.

  PMID: 37954781 RESULT

• 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.

  PMID: 35345532 RESULT

• 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.

  PMID: 37772295 RESULT

MeSH Terms

Conditions

Restless Legs Syndrome; Pain; Sleep Initiation and Maintenance Disorders

Interventions

Vibration

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Central Study Contacts

Ainon Saleem

CONTACT

+923208438852; ainonsaleem246@gmail.com

Salwa Atta

CONTACT

+923084579229; salwa.atta@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After recruitment of participants into the study, they will be allocated to their respective group utilizing the online randomization tool.

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: December 29, 2025
• Study Start: December 14, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share