Clinical trial NCT06918847: Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.
Official title: Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.A RCT
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Restless Leg Syndrome With Knee OA
Sleep Disorder
Keywords: Restless leg syndrome
knee OA
cupping therapy
myofacial release
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 54
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Restless leg syndrome quality of life Questionnaire
timeFrame: Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.
measure: International restless leg syndrome study group rating scale
timeFrame: Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow Institute of Physical Medicine and Rehabilitation
state: Sindh
Study officials:
References:
citation: 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.
citation: 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.