A double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in the pain management of tennis elbow in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Pain Numeric Rating Scale (NRS)
研究概览
简要总结
Tennis elbow (TE), commonly known as lateral epicondylitis, is the leading cause of musculoskeletal elbow pain, that severely impairs upper limb function. It results from repetitive forearm prono-supination and elbow extension, with risk factors including tendon deterioration and blood supply disruption. Homeopathy is one of the most frequently used complementary and alternative medicine (CAM) therapies in children as well as in adults. Limited research in tennis elbow includes a study on a complex remedy for tendinitis, one comparing Ruta graveolens to IHMs, and an underpowered trial, missing its target sample size where IHMs outperformed placebo. This study replicates a prior homoeopathic trial to validate the efficacy of individualized homoeopathic medicines in tennis elbow using a double-blind, randomized (2:1), placebo-controlled design on 96 adults with tennis elbow. Assessment will be done by evaluating the Numeric rating scale (NRS) (Primary outcome), Patient rated tennis elbow evaluation (PRTEE) (secondary outcome) every month upto 3 months. Assessment of susceptibility, miasmatic analysis and treatment outcome using PRATHoT v 2.2 tool. Comparative analysis will be carried out to detect group differences
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 18 to 65 years
- •Either sex or transgender
- •Patients having lateral elbow pain for more than or equal to 12 weeks, tenderness over the lateral epicondyle, and pain on resisted wrist extension
- •Clinical diagnosis of TE confirmed by positive Cozens test and Mills test
- •Patients with ability to understand English or Hindi or Bengali.
排除标准
- •Denying informed consent
- •Severe pain (NRS more than 7)
- •Patients with previous trauma and or undergone surgery of the elbow region
- •Patients who are undergoing treatment with NSAIDS during 4 weeks prior to enrolment in the study
- •Elbow pain due to peripheral nerve entrapment, cervical radiculopathy
- •Corticosteroid injection within 6 months
- •Vulnerable population unconscious, non ambulatory, too sick for, differently abled or mentally incompetent, unstable mental or psychiatric illness or other systemic diseases (e.g. uncontrolled hypertension, diabetes, thyroid diseases etc.)
- •Pregnancy, nursing mothers, and puerperal women
- •Chewing tobacco, smoking, alcoholism, substance misuse in any form, and or dependence (TAPS tool)
- •Receiving homoeopathic treatment for a chronic illness all through the previous three months
- •Simultaneously taking part in any other clinical trial.
结局指标
主要结局
Pain Numeric Rating Scale (NRS)
时间窗: At baseline, monthly, up to 3 months
次要结局
- Patient-Rated Tennis Elbow Evaluation (PRTEE) scores(At baseline, monthly, up to 3 months)
- Susceptibility assessment tool(At baseline)
- Miasm checklist(At baseline)
- Patient Response Assessment Tool after Homeopathic therapeutic (PRATHoT v 2.2)(Monthly, up to 3 months)
- Time to clinical recovery(Every month, up to 3 months)
研究者
Abha Kumari
D.N.De Homoeopathic Medical College and Hospital