A Randomised Control Trial of Arthroscopic Capsular Release Versus Hydrodilatation for Primary Adhesive Capsulitis of the Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Oxford shoulder score
研究概览
简要总结
To compare the Oxford shoulder score at 6 months post intervention for primary frozen shoulder randomised to either an arthroscopic capsular release or hydro-dilatation
详细描述
All potential participants for this study will be identified by an Orthopaedic Shoulder Consultant in the shoulder clinics run at the Royal Devon and Exeter NHS trust. The patients will be screened for eligibility by a research associate (SG). The eligibility criteria will be that the patient is medically fit for an operation, and has severe primary frozen shoulder in the acute painful stage, that is deemed suitable for intervention by the consultant surgeon. The patients will be informed verbally and in writing about the trial by the research associate and informed consent will be taken.
The participating patients will be randomised in a 1:1 allocation to arthroscopic capsular release (ACR) or hydrodilatation (HD). The randomisation will be administered by a central independent randomisation service, provided by a medical secretary using a computer generated randomisation sequence, who is completely independent of the trial.
All patients will be asked to fill out a number of questionnaires prior to surgery: the Oxford Shoulder Score (OSS) and the EQ-5D. The range of movement within the shoulder joint will be documented in a standard fashion.
Each patient will then undergo the assigned procedure according to the randomisation. The ACR would be performed by one of the Consultant Shoulder surgeons in their standard manner. The Hydro-dilatation would be performed by one of the Consultant Musculoskeletal radiologists in their standard manner. This would ensure that the options at each step of the operation or procedure, such as patient positioning, approach to the shoulder joint, and the closure of the wound etc are left entirely to the discretion of the Consultant performing the procedure. This will ensure that the results of the trial can be generalised to as wide a group of patients and surgeons as possible.
After the operation, patients will be reviewed using the range of movement, OSS, a patient satisfaction score and EQ-5D at 6 weeks, 3 months, and 6 months post-operatively. A record will be kept of any complications associated with the treatment. This data will be collected with by the research associate, who is independent of either intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
independent clinical reviewer of patients ROM and collection of outcome scores
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically fit for an operation; normal x-ray; Codmans criteria frozen shoulder
排除标准
- •Secondary causes of frozen shoulder; rotator cuff tears found at arthroscopy or hydro-dilatation; unable to adhere to trial protocol
研究组 & 干预措施
Hydro-dilatation
injection of water under local anesthetic in to shoulder joint
干预措施: Hydro-dilatation (Procedure)
Arthroscopic capsular release
Surgical release performed under general anesthetic
干预措施: arthroscopic capsular release (Procedure)
结局指标
主要结局
Oxford shoulder score
时间窗: at 6months
Patient reported outcome with a maximum score of 48 and minimum of 0. 48 being the best outcome. Comprises 12 questions relating to pain and function specific to the shoulder
次要结局
- clinical assessment of range of movement (external rotation, internal rotation, forward flexion and abduction)(at 6 months)
- Visual analogue score(at 6 months)