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临床试验/NCT06987929
NCT06987929已完成不适用

A Randomised Controlled Trial Comparing the Efficacy of Ultrasound-guided Hydrodilatation With Intra-articular Corticosteroid Injection in the Treatment of Adhesive Capsulitis.

Singapore General Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Shoulder Pain and Disability Index (SPADI)

研究概览

简要总结

This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-intervention.

详细描述

Adhesive capsulits is a common shoulder condition that causes significant pain and loss of joint mobility, thus affecting the quality of life. If left untreated, the symptoms can impair the person's function and persist for a longer duration. Both hydrodilatation and standard steroid injection into the glenohumeral joint are well recognised forms of treatment, but there is no consensus on the best treatment approach for adhesive capsulitis. Hydrodilatation involves injecting a larger volume of solution (with steroid and local anaesthetic mixed), into the space within the rotator cuff interval, leading to intra-articular distension of the joint capsule. The local anaesthetic used in the procedure provides immediate pain relief, while the long-term benefit comes from the resolution of the capsular stiffness and inflammation. This process stretches the capsule, resulting in adhesion breakdown and promoting the remodeling of the shoulder capsule, hence improving shoulder range of motion (ROM), especially in those with limited mobility due to the capsular tightening. This study aims to evaluate the effectiveness of HD compared with intra-articular corticosteroid injection (IAI) in patients with adhesive capsulitis, with pain and function as the primary outcomes. We conducted a prospective, randomised controlled trial conducted in the Rheumatology department of a tertiary centre. Twenty patients with adhesive capsulitis were recruited and randomised equally to receive HD (n = 10), and IAI (n = 10). The primary outcome measures include Shoulder Pain and Disability Index (SPADI), QuickDASH questionnaire score, pain visual analogue scale (VAS) score, and range of motion (ROM) at 6-weeks post-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
None

盲法说明

Open label

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adhesive capsulitis or frozen shoulder, diagnosed clinically, with or without imaging,
  • •persistent symptoms of pain and restricted ROM for at least 3 months, despite conservative management with physiotherapy and/or analgesia

排除标准

  • •previous surgery or shoulder implants of the affected shoulder,
  • •history of recent trauma or fracture involving the affected shoulder,
  • •age below 21 years,
  • •pregnant women,
  • •any evidence of ongoing active systemic inflammatory arthritis,
  • •allergy to any of the injectates,
  • •patients on anticoagulation (warfarin or direct oral anticoagulant),
  • •received any joint injection in the past 6 months.

研究组 & 干预措施

Conventional Group

Other

干预措施: Intra-articular steroid injection (IAI) (Procedure)

Hydrodilation

Active Comparator

干预措施: Hydrodilatation injection (Procedure)

结局指标

主要结局

Shoulder Pain and Disability Index (SPADI)

时间窗: 6 weeks

SPADI: self-reported questionnaire by patient on pain and disability.

QuickDASH score

时间窗: 6 weeks

self-reported questionnaire by patient on upper extremity disability

Pain score

时间窗: 6 weeks

self-reported by patient using visual analogue scale (VAS).

Active and passive range of motions (ROM):

时间窗: 6 weeks

measured by investigators blinded to the treatments.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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