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Recruiting NCT06918847

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

No phase Interventional Restless Leg Syndrome With Knee OA Sleep Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myofacial release, Dynamic cupping therapy.
Who it may be relevant to
Registry conditions: Restless Leg Syndrome With Knee OA, Sleep Disorder. Basic parameters: 40 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • Other Myofacial release
    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.
  • Other Dynamic cupping therapy
    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 the

Primary outcome measures

  • Restless leg syndrome quality of life Questionnaire [Time frame: 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 [Time frame: Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Dow Institute of Physical Medicine and Rehabilitation — Karachi

Publications

  • 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
  • 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

Identifiers

NCT: NCT06918847 · 3866

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗