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

NCT06918847 | Recruiting

• 1 other identifier: 3866
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Leg Syndrome With Knee OA; Sleep Disorder

Keywords

Restless leg syndrome; knee OA; cupping therapy; myofacial release

Outcome Measures

Primary Outcomes (2)

• Restless leg syndrome quality of life Questionnaire

  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.

  Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.

• International restless leg syndrome study group rating scale

  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.

  Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.

Study Arms (2)

Group A will be given treatment with myofacial release

EXPERIMENTAL

Myofascial release (MFR) for the calf muscle will be administered with the patient in a prone position, holding for 120 seconds. The Myofacial release technique involves allowing the lateral aspect of the therapist's thumb to sink into the central portion of the muscle belly. Myofacial release will be performed for 15 minutes.

Other: Myofacial release

Group B will be given treatment with dynamic cupping therapy

EXPERIMENTAL

In dynamic cupping therapy, patients will be comfortably positioned in a prone position, ensuring that the lower limb is exposed and accessible for treatment. Appropriately sized cups will be selected and applied to the calf and hamstrings region. Prior to application, a small amount of lubricant or oil will be applied to facilitate the smooth movement of the cups over the skin surface during the therapy. The technique of dynamic cupping will involve compressing the cups and gently situating them onto the area being treated, applying the necessary force to generate negative pressure. The duration of dynamic cupping therapy will be 10 minutes.

Other: Dynamic cupping therapy

Interventions

Myofacial release OTHER

Myofascial release (MFR) for the calf muscle will be administered with the patient in a prone position, holding for 120 seconds. The MFR technique involves allowing the lateral aspect of the therapist's thumb to sink into the central portion of the muscle belly. MFR will be performed for 15 minutes.

Also known as: MFR

Group A will be given treatment with myofacial release

Dynamic cupping therapy OTHER

In dynamic cupping therapy, patients will be comfortably positioned in a prone position, ensuring that the lower limb is exposed and accessible for treatment. Appropriately sized cups will be selected and applied to the calf and hamstrings region. Prior to application, a small amount of lubricant or oil will be applied to facilitate the smooth movement of the cups over the skin surface during the therapy. The technique of dynamic cupping will involve compressing the cups and gently situating them onto the area being treated, applying the necessary force to generate negative pressure. The duration of dynamic cupping therapy will be 10 minutes.

Group B will be given treatment with dynamic cupping therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients with cognitive dysfunction
• Rheumatoid arthritis
• patients with neurological disorders
• Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, 74200, Pakistan

RECRUITING

Related Publications (2)

• Guo S, Huang J, Jiang H, Han C, Li J, Xu X, Zhang G, Lin Z, Xiong N, Wang T. Restless Legs Syndrome: From Pathophysiology to Clinical Diagnosis and Management. Front Aging Neurosci. 2017 Jun 2;9:171. doi: 10.3389/fnagi.2017.00171. eCollection 2017.

  PMID: 28626420 RESULT

• Vlasie A, Trifu SC, Lupuleac C, Kohn B, Cristea MB. Restless legs syndrome: An overview of pathophysiology, comorbidities and therapeutic approaches (Review). Exp Ther Med. 2022 Feb;23(2):185. doi: 10.3892/etm.2021.11108. Epub 2021 Dec 30.

  PMID: 35069866 RESULT

Related Links

• Exploration of restless legs syndrome under the new concept: A review

MeSH Terms

Conditions

Sleep Wake Disorders; Restless Legs Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Syeda Tooba Batool, doctor of physical therapy

CONTACT

+923362196775; stb.dow@gmail.com

Dr. Farhan Ishaque Khan, Ph.D.

CONTACT

+923332209704; farhan.ishaque@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, a Physiotherapist

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 9, 2025
• Study Start: May 5, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 7, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)