A Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Frozen Shoulder
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Oxford Shoulder Score (OSS) measuring intensity of pain and related quality of life
研究概览
简要总结
Frozen shoulder is a painful, often prolongedcondition that is commonly managed in the primary care setting and requirescareful clinical diagnosis and management. Despite over a hundred years of treating frozen shoulder, the definition, diagnosis, pathology and most efficacioustreatments are still unclear. Systemic reviews of current treatments forfrozen shoulder examine the evidence base behind physiotherapy, both oral andintra-articular steroid, hydro-dilatation, manipulation under anaesthesiaand arthroscopic capsular release. Frozen shoulder is a self-limiting condition,lasting on average 2-3 years, and some study shows 20-50% of sufferers continueto have pain and restricted movement beyond 3 years. The precise prevalence is unknown, thus 2-5% foundin general population. Homeopathy treatment for the said condition is claimed to be beneficial, still systematic research evidences remain compromised. In this prospective, double blind, randomised, placebo controlled, parallel arm trial aimed to evaluate the efficacy of individualised homeopathic treatment against placebo in treatment of frozen shoulder at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, 128 patients will be randomised in 1:1 ratio into either individualised homeopathic medicines or identical placebo. Oxford Shoulder Score (OSS) and Shoulder Pain and Disability Index (SPADI) will be used as the primary and secondary outcome measures respectively, measured at baseline, and every month up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant, Investigator and Outcome Assessor 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
- •a) Cases suffering from frozen shoulder (ICD M75.02) for at least 3 months b) Age 18-65 yrs c) Both sexes d) Patient having on ongoing standard or other alternative therapy for frozen shoulder, discontinued for at least 1 month e) Literate patients; ability to read English and/or Bengali and capability and willingness to give informed consent and to comply with the study procedure.
排除标准
- •a) Cases too sick for consultation b) Cases unwilling to stay after the doctor’s visit c) Patients unable to read patient information sheet d) Patients unwilling to take part or not giving consent to join the study e) Cases willing for or requiring immediate surgical intervention or undergoing major shoulder surgery in last 6 months f) Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure g) Patient with psychiatric disorders h) Undergoing homoeopathic treatment for chronic disease within last 6 months i) Self-reported immune-compromised state j) Substance abuse and/or dependence k) Pregnant and lactating women.
结局指标
主要结局
Oxford Shoulder Score (OSS) measuring intensity of pain and related quality of life
时间窗: At baseline, every month up to 3 months
次要结局
- Shoulder Pain and Disability Index (SPADI) measures pain and disability(At baseline, every month up to 3 months)
