Restless Leg Syndrome With Knee OARCTNCT06918847
Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.
A study testing Myofacial release and Dynamic cupping therapy in people with Restless Leg Syndrome With Knee OA and Sleep Disorder, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Restless Leg Syndrome With Knee OA, Sleep Disorder
- What is being tested?
- Myofacial release and Dynamic cupping therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with cognitive dysfunction
- Rheumatoid arthritis
- patients with neurological disorders
- Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dow Institute of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
About this study
Official title: Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.A RCT
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
- Being tested
- Myofacial release, Dynamic cupping therapy
- Keywords
- Restless leg syndrome, knee OA, cupping therapy, myofacial release
- Medical subject headings
- Sleep Wake Disorders, Restless Legs Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myofacial releaseOther
Also called MFR
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.
Dynamic cupping therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dynamic cupping therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Assessment of outcome measure will be done at baseline and at the post intervention i.e 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start5 May 2025
- Primary completionNov 2025 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Restless Leg Syndrome With Knee OAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tooba Batool, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918847
- Sponsor's protocol ID
- 3866
- Acronym
- RCT
- Status last verified
- Oct 2025
- First submitted
- 8 Apr 2025
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28626420Vlasie 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.
PubMed 35069866
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.A RCT
- ClinicalTrials.gov ID
- NCT06918847
- Acronym / sponsor ID
- RCT / 3866
- Conditions
- Restless Leg Syndrome With Knee OA, Sleep Disorder
- Keywords
- Restless leg syndrome, knee OA, cupping therapy, myofacial release
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 5 May 2025 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A will be given treatment with myofacial release | Experimental | Other: Myofacial releaseMyofascial 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 B will be given treatment with dynamic cupping therapy | Experimental | Other: Dynamic cupping therapyIn 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- patients with cognitive dysfunction
- Rheumatoid arthritis
- patients with neurological disorders
- Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myofacial releaseAlso: MFRMyofascial 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 | Group A will be given treatment with myofacial release |
| Dynamic cupping therapyIn 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 | Group B will be given treatment with dynamic cupping therapy |
Primary outcome
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.
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 scale
Time frame: Assessment 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2025.
- Results publication: PubMed 28626420Guo 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.
- Results publication: PubMed 35069866Vlasie 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myofacial release and Dynamic cupping therapy in people with Restless Leg Syndrome With Knee OA and Sleep Disorder, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Syeda Tooba Batool, doctor of physical therapy (+923362196775, stb.dow@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06918847, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2025.