跳至主要内容
临床试验/CTRI/2018/10/016017
CTRI/2018/10/016017Other3 期

A Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Individualized Homeopathic Medicines in Frozen Shoulder

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2018年1月11日最近更新:

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)

研究者

发起方
Mahesh Bhattacharyya Homoeopathic Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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