A Open Label Randomized Controlled Trial on Marmachikitsa in the management of Sport injury with special reference to Tennis elbow
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- To study the effects of Marmachikitsa in the management of Tennis
研究概览
简要总结
This study is an open labelled, randomized ,parallel group,controlled trial to study the effects of MARMACHIKITSA in the management of Tennis elbow.Total 128 subjects fulfilling inclusion criteria will be selected for study and divided into two groups(group A and group B) by Computerized Generated Randomized method.The subjects of Group A will be given Marmachikitsa daily and group B will be treated by Agnikarma with Guda paka(Maximum 02 sittings of 01-week interval) for 15 days.Assessment will be done based on subjective and objective parameters on D1, D8, D15, D30 and D45 (follow up).The primary outcome measures will be relief from the symptoms of Tennis elbow like 1.Kurpar sandhi Stambha (Stiffness in elbow joint) and 2.Kurpar sandhi Shopha (Elbow swelling). The secondary outcome measures will be overall improvement in the objective criterias like 1.Akunchana Prasharana Apravritti (Range of movement will be measured with Goniometer)2.Questionnaire ( The patient specific functional scale)3.Weakness on Grip test ( by Dynamometer )4.VAS scalefor pain.Statistical analysis with appropriate tests and interpretation will be done after the study and conclusion will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients suffering from Tennis elbow (Pain, Stiffness and Restricted range of motion of elbow joint (ROM) with VAS more than
- •Patients willing to undergo trial.
- •Patients with the age group 20-50 years .
- •Patient with H/o repeated trauma to elbow joint
- •Patient with c/o Tennis elbow more than 3 months.
- •Patients with controlled diabetes mellitus.
排除标准
- •Not willing to undergo trial.
- •Age below 20 years and above 50 years..
- •Patient with H/o inflammatory arthiris or gross structural abnormality.
- •Patient with any co existing major illness like cardiac diseases, TB, Asthama.
- •Patients associated with Golfer’s elbow,Olecranon bursitis, Radial tunnel syndrome etc.
- •Patients with history of compound fracture, Pathological fracture, nonunited fracture and mal-united fracture of complaining limb.
- •Patient with significant radiculopathy.
- •Patient with any Neoplastic lesion.
结局指标
主要结局
To study the effects of Marmachikitsa in the management of Tennis
时间窗: At baseline, 1 week,2 weeks,4 weeks,and 6 weeks (follow up)
elbow with grade reduction in 1.Kurpar sandhi Stambha (Stiffness in elbow joint) 2.Kurpar sandhi Shopha (Elbow swelling)
时间窗: At baseline, 1 week,2 weeks,4 weeks,and 6 weeks (follow up)
次要结局
- 1.To study the effect of Agnikarma in the management of Tennis elbow.(2.To compare the effects of Marmachikitsa & Agnikarma for Tennis elbow)
研究者
Dr Nirmala Chandrabhanji Apaturkar
Govt Ayurved College, Nagpur