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

NCT ID: NCT06918847

Last Updated: 2025-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-05

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Restless Leg Syndrome With Knee OA Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group A will be given treatment with myofacial release

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.

Group Type EXPERIMENTAL

Myofacial release

Intervention Type 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.

Group B will be given treatment with 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 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 Type EXPERIMENTAL

Dynamic cupping therapy

Intervention Type 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.

Interventions

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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.

Intervention Type 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 them onto the area being treated, applying the necessary force to generate negative pressure. The duration of dynamic cupping therapy will be 10 minutes.

Intervention Type OTHER

Other Intervention Names

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MFR

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Tooba Batool

Principal investigator, a Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dow Institute of Physical Medicine and Rehabilitation

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Syeda Tooba Batool, doctor of physical therapy

Role: CONTACT

+923362196775

Dr. Farhan Ishaque Khan, Ph.D.

Role: CONTACT

+923332209704

References

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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.

Reference Type RESULT
PMID: 28626420 (View on PubMed)

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.

Reference Type RESULT
PMID: 35069866 (View on PubMed)

Related Links

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Other Identifiers

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3866

Identifier Type: -

Identifier Source: org_study_id

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