Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.

Not Applicable

Not yet recruiting

• Conditions: Restless Leg Syndrome With Knee OA; Sleep Disorder

• Registration Number: NCT06918847
• Lead Sponsor: Dow University of Health Sciences

Brief Summary

The aim of this study is to determine effectiveness of Myofascial Release and Cupping Therapy on Quality of Life in Restless Leg Syndrome with knee Osteoarthritis. Holding this aim, a Randomized control trial will be conducted at physiotherapy out patient department of Dow Institute of Physical Medicine and Rehabilitation.

The subjects will first be screened by the principal investigator, physiotherapist, using the criteria of International Restless Leg Syndrome Study Group (IRLSSG). Each selected subject will go for random allocation in one of the two treatment groups with different interventions with the help of a computer-generated randomization sheet. The group A will be provided with myofacial release whereas the group B will receive cupping therapy while cryotherapy and passive lower limb stretches (hamstring and calf muscles) will be applied to both the groups as standard treatment. Assessment will be done at baseline and will re-evaluate at the post intervention session through an assessment form. Physical therapist but not the principal investigator will assess who will be unaware to the type of intervention administered.

Outcome measures will be Pittsburgh sleep quality index, Visual Analog Scale for pain assessment, Restless leg syndrome Quality of life questionnaire (RLS-QOL), International Restless leg syndrome Study Group Rating Scale (IRLSSG RS) and passive straight leg raise (PSLR). Total 12 sessions will be given for duration of 4weeks on alternate days.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-08
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-09
• Last Update Posted: 2025-04-10
• Study Start: 2025-05
• Primary Completion: 2025-11
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

1. grade 2, 3 and 4 knee OA by the Kellgren Lawrence classification
2. Bilateral or unilateral both knee OA
3. Age 40 to 70 years
4. Patients who were meeting the International Restless Leg Syndrome Study Group (IRLSSG) eligibility criteria

Exclusion Criteria

1. patients with cognitive dysfunction
2. Rheumatoid arthritis
3. patients with neurological disorders
4. Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Restless leg syndrome quality of life Questionnaire	Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.	The Restless Leg Syndrome Quality of Life Questionnaire is a scale ranges from 0-100 with a desirable internal consistency (Cronbach's alpha =0.92) and test-retest reliability (intraclass correlation coefficient=0.84.All items possess considerable convergent validity.
International restless leg syndrome study group rating scale	Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.	The International restless leg syndrome study group rating scale comprises of 10 questions with ratings 0 to 4. The scale is a face-to-face interview validated questionnaire to clear the ambiguities of the subjects regarding the questions given.; IRLSSG RS Inter rater reliability ICC = 0.97 IRLSSG RS Test-retest reliability ICC = 0.87 Internal consistency (cronbach's alpha) = 0.95 Criterion validity = 0.73.

Trial Locations

Locations (1)

Dow Institute of Physical Medicine and Rehabilitation; 🇵🇰 Karachi, Sindh, Pakistan