An Open Single Arm Clinical Trial to Determine the Therapeutic effect of Varmam Manipulation Technique with Vasavaathi thailam (External) for The Management of Puramuli Thaabitham (Lateral Epicondylitis-Tennis Elbow)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- For clinical significance defined as ‘little better’ the MCID of total PRTEE score is 7 points or 22% of baseline score.
研究概览
简要总结
An open single arm clinical trial to determine the therapeutic effect of varmam manipulation technique with vasavaathi thailam for the management of Puramuli thaabitham (Lateral epicondylitis -Tennis elbow )will be carried out for 49 days in Varma maruthuvam OPD,Ayothidoss pandithar hospital,National institute of siddha with 30 patients as sample size.The patients will be non randomly selected based on inclusion and exclusion criteria for enrollment in the study and treated with 14 sittings of varmam manipulation technique-varma thadaval weekly twice for 7 weeks. Prognosis will be documented in the appropriate forms enclosed in the protocol. The outcome of the study will be assessed by the PRTEE score before and after treatment and the results will be statistically analysed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants with pain, tenderness, stiffness in the lateral side of elbow joint.
- •Participants with positive response in the following provocative tests Mills test, Cozens test, Maudsley test.
- •(15) Participants with the symptoms of lateral epicondylitis for the time period of greater than 4 weeks to 6 months.
- •Based on PRTEE Questionnaire, participants with score range of 40 to 80 of total score 100.
排除标准
- •Musculoskeletal conditions like Inflammatory and Infective arthritis, Dislocations and deformities in upper extremities, Myositis ossificans etc.
- •Nerve entrapment condition of upper limb.
- •History of trauma, fracture and surgical procedure in upper limb.
- •Uncontrolled Diabetes Mellitus.
- •Pregnant and lactating women.
- •Any other serious systemic illness.
结局指标
主要结局
For clinical significance defined as ‘little better’ the MCID of total PRTEE score is 7 points or 22% of baseline score.
时间窗: 49 th day
For clinical significance defined as ‘completely recovered’ the MCID of total PRTEE score is 11 points or 37% of baseline score.
时间窗: 49 th day
Reduction of Patient Related Tennis Elbow Evaluation Questionnaire (PRTEE) score from the baseline assessment.
时间窗: 49 th day
次要结局
- not applicable(not applicable)
研究者
Jayachitra K
National Institute of Siddha