Safety and efficacy of a novel Agnikarma device and conventional Agnikarma method in the management of Tennis elbow pain - A pilot study.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual analog scale
研究概览
简要总结
Tennis elbow or lateral epicondylitis is a common condition of young and middle aged people, where the patient complains of pain in the elbow particularly in certain movements like pouring the tea, turning of stiff door handle, lifting the mug etc. Due to unaccustomed use there will be damage to the common extensor origin which is attached to the lateral epicondyle. Damage is followed by subsequent adhesions with untorn fibers and joint capsule. It is clinically diagnosed by sensation of pain and tenderness at the lateral epicondyle of humerus, which aggravates during the resisted dorsiflexion of the wrist and fingers. Tennis elbow may be correlated with the condition of Snayugata vata, described in Ayurveda. Ayurveda has advocated various treatment modalities such as Snehana, Upanaha, Agnikarma and Bandhana for snayugatavata. Among these Agnikarma seems to be more effective in providing instant symptomatic relief. Agnikarma is a therapeutic heat burn therapy performed with the help of hot Shalaka (Probe) and it is an effective procedure for management of pain in Ayurveda. This pilot trial aims to evaluate the comparative safety and efficacy of a Novel Agnikarma device and conventional agnikarma method in reducing pain of Tennis elbow. 20 subjects satisfying the inclusion criteria will be screened and selected for the study. The criteria of assessment is pain, tenderness, response to Cozen’s test and post operative assessment – Burn, Allergic reactions, surgical site infections, other adverse events. The subjects will be assessed before treatment, immediately after treatment and on 7th day of treatment using required assessment scales
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
- 25.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- ••Subjects satisfying diagnostic criteria of tennis elbow, i.e. pain and tendernes on the lateral epicondyle of humerus bone and a positive response to Cozen’s test.
- ••Age group – 25 to 60 years, irrespective of gender.
- ••Subjects ready to give written informed consent and willing to comply the study protocol.
排除标准
- •1.Subjects with uncontrolled Diabetes mellitus.
- •2.Subjects with the history of Malignant tumors, senile osteoporosis in and around the elbow region, compound fracture/ pathological fracture, non-united fracture of lateral epicondyle.
- •3.Subjects suffering from infectious diseases like HIV or Hepatitis B.
- •4.Subjects on any Analgesics or NASIDS or corticosteroids.
- •5.Pregnant or lactating females.
- •6.Presence of any severe medical or psychological condition or chronic condition/ inflammation/ infection.
结局指标
主要结局
Visual analog scale
时间窗: ( o th day – before and after procedure , 7 th day
Tenderness over lateral epicondyle
时间窗: ( o th day – before and after procedure , 7 th day
response to cozens test
时间窗: ( o th day – before and after procedure , 7 th day
次要结局
- post operative assessment - burn, allergic reactions, surgical site infections , other adverse events(after procedure and 7 th day)
研究者
Dr Sheela Karalam B
Vaidyaratnam Ayurveda Research Institute
