Effect of Glucosamine, Chondroitin and Some Herbs Extract Phonophoresis in the Treatment of Grade I and II Knee Meniscal Injuries: a Randomized Placebo-controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- pain severity measured by Numerical Rating Scales (NRS)
研究概览
简要总结
Hypothesis: In grade I and II meniscal injury patients, 1) GL and CH (PH) decrease knee pain severity measured by Numerical Rating Scales (NRS) more than only topical application. 2) GL and CH (PH) improve knee functional abilities measured by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) more than only topical application.
详细描述
Design and Setting: We propose a randomized (1:1:1) controlled, clinical trial to enroll grade I and II knee meniscal injuries' patients and to study the effect of GL, CH and some natural herbs (PH) in decreasing knee pain intensity measured by NRS and improving knee functional abilities measured by WOMAC. The study will be conducted in physical therapy outpatient clinic at Alahrar teaching hospital, Zagazig, Egypt.
Inclusion and Exclusion criteria: patients will be included to this study
- if they have grade I or II knee meniscal tear assessed by MRI according to radiologist report
- positive McMurray's test assessed by physical therapist
- aged from 18 to 40 years.
Exclusion criteria:
- grade III meniscal injury as it is supposed that they need more physical therapy sessions.
- Ages above 40 is excluded to exclude arthritic changes.
- Presence of any other knee injury or systemic diseases affecting joints (e.g. rheumatoid arthritis) will be excluded.
- Patients with body mass index (BMI) more than 30 will be excluded as their knees may have some arthritic changes and need longer PT sessions.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •grade I or II knee meniscal tear assessed by MRI according to radiologist report, positive McMurray's test assessed by physical therapist and aged from 18 to 60 years.
排除标准
- •We suggest not to include grade III meniscal injury as it is supposed that they need more physical therapy sessions. Ages above 40 is excluded to exclude arthritic changes. Presence of any other knee injury or systemic diseases affecting joints (e.g. rheumatoid arthritis) will be excluded. Patients with body mass index (BMI) more than 30 will be excluded as their knees may have some arthritic changes and need longer PT sessions.
结局指标
主要结局
pain severity measured by Numerical Rating Scales (NRS)
时间窗: before intervention and two days after last session
zero , no pain .10 maximum pain
次要结局
- knee functional abilities measured by Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)(before intervention and two dayes after last sesssion)
研究者
Eslam Elsayed Ali Shohda
Dr Eslam Shohda-Principal Investigator
General Committee of Teaching Hospitals and Institutes, Egypt