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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06918847
Acronym
RCT
Enrollment
54
Registered
2025-04-09
Start date
2025-05-05
Completion date
2026-07-31
Last updated
2025-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Leg Syndrome With Knee OA, Sleep Disorder

Keywords

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

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.

Interventions

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.

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.

Sponsors

Dow University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Restless leg syndrome quality of life QuestionnaireAssessment 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 scaleAssessment 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.

Countries

Pakistan

Contacts

Primary ContactSyeda Tooba Batool, doctor of physical therapy
stb.dow@gmail.com+923362196775
Backup ContactDr. Farhan Ishaque Khan, Ph.D.
farhan.ishaque@duhs.edu.pk+923332209704

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026