Comparative Effectiveness of Myofacial Release vs Cupping Therapy on Quality of Life in Restless Leg Syndrome With Knee O.A.A RCT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Restless leg syndrome quality of life Questionnaire
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •patients with cognitive dysfunction
- •Rheumatoid arthritis
- •patients with neurological disorders
- •Medical conditions covering (cardiovascular disease, neurological disorders, severe psychiatric illness or pregnancy)
研究组 & 干预措施
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.
干预措施: Myofacial release (Other)
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.
干预措施: Dynamic cupping therapy (Other)
结局指标
主要结局
Restless leg syndrome quality of life Questionnaire
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Tooba Batool
Principal investigator, a Physiotherapist
Dow University of Health Sciences