Effectiveness of Physical Therapy on Stem Cell Transplantation Recipients in Improving Pain, Quadriceps Muscle Strength and Functional Status of Knee Osteoarthritis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
研究概览
简要总结
Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Recent efforts to investigate the possibility of stem cell therapies in the treatment of symptomatic osteoarthritis have seen an increase in interest in regenerative medicine, fueled a better understanding of the role of mesenchymal stem cells. Knee osteoarthritis is mostly managed by physical therapy, focused on managing pain, increasing the restricted range of motion and muscle strengthening. Therefore, the hypothesis is that combining both treatments will be beneficial for patients. The aim of this randomized controlled trial is to evaluate the effectiveness of physiotherapy in mesenchymal stem cell recipient in improving pain, quadriceps muscle strength and functional status of knee osteoarthritis patients.
详细描述
A single blinded RCT will be conducted at Ortho Stem Cell Department, AlKhaleej Clinics. Collection of data will be started after the scientific and ethical approval from Dow University, Karachi. After screening by physician and fulfilling the inclusion and exclusion criteria, patients (n=48) will be enrolled. After briefing about the objectives and obtaining formal consent, data will be collected. Participants will be randomized and equally distributed into two groups i.e., twenty-four in control group '1' and twenty-four in treatment group '2'. The control group '1' will receive forward walking in home program after mesenchymal stem cell treatment while the treatment group '2' will be receiving quadriceps isometric exercise, straight limb raises (SLR), hip isometric adductor, knee terminal extension, semi wall squat, quadriceps drill exercises for knee osteoarthritis after mesenchymal stem cell therapy. Treatment plan will be of 8 weeks with 3 sessions in one week for 30 minutes. A physical therapist will do the assessment at baseline and at the end of treatment, other than the principal investigator to measure outcomes by using KOOS score, manual muscle testing and VAS scale. For the completion of the study 6 months are required after synopsis approval.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of age 40 years and above.
- •Male and female both will be included.
- •Patients with single or both knee OA.
- •Patients who had mesenchymal stem cell transplantation.
- •Kellgren and Lawrence grade II, III on radiological findings.
排除标准
- •Patients with any neurological disorder.
- •Any musculoskeletal deformity (varus/valgus).
- •Patients who have had any type of lower limb internal fixation.
- •Patients who have had any type of lower limb arthroplasty or other knee surgery in the past.
- •Patients with a history of any infectious or malignant condition.
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (change is being assessed)
时间窗: Baseline and 8 weeks
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint. The Knee injury and Osteoarthritis Outcome Score contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sports/recreation, and quality of life. A patient's maximum score is 100, which indicates that they have no knee concerns. The lowest possible score is 0, which indicates serious knee issues.
次要结局
- Manual Muscle Testing (change is being assessed)(Baseline and 8 weeks)
- Visual analog scale (change is being assessed)(Baseline and 8 weeks)
研究者
Syed Muhammad Zaeem Hasan Zaidi
Principal Investigator
Dow University of Health Sciences