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临床试验/CTRI/2025/10/095568
CTRI/2025/10/095568尚未招募不适用

A Three-arm Randomized Control Trial Comparing Efficacy of Hydrodistension Hydrodistension With Suprascapular Nerve Block And Suprascapular Nerve Block Alone In Patients With Stage II and III (Hannafin And Chaia Staging) Adhesive Capsulitis

AIIMS1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2025年10月26日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
AIIMS
入组人数
54
试验地点
1
主要终点
Improvement in range of motion

研究概览

简要总结

Adhesive capsulitis is a common shoulder disorder characterized by pain and restricted range of motion. Various treatments exist, but the most effective approach remains uncertain. This randomized controlled trial will compare the functional outcome of three treatment methods for Hannafin and Chiaia stage II and III adhesive capsulitis of the shoulder. The study will be conducted in the Department of Orthopaedics at AIIMS Bibinagar over a period of two years from June 2025 to June 2027. A total of 54 adult patients meeting Zuckerman diagnostic criteria will be enrolled and randomly allocated into three equal groups. Group one will receive ultrasound guided hydrodistension of the glenohumeral joint with corticosteroid and normal saline. Group two will receive hydrodistension combined with suprascapular nerve block, and group three will receive suprascapular nerve block alone. All participants will perform a supervised shoulder exercise program after the intervention. Pain will be measured using the Visual Analogue Scale, shoulder function by the Shoulder Pain and Disability Index and Quick DASH scores, and range of motion by goniometer at baseline and at day 2, week 2, week 4, week 8, and week 12. Data will be analyzed using appropriate statistical tests with a significance level of 0.05. The trial aims to identify which treatment provides the best pain relief, range of motion, and functional recovery in adhesive capsulitis.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • All adult patients who have given consent for the study and diagnosed to have primary Adhesive capsulitis based on Zuckerman`s criteria and are in Stage II & III (Hannafin and Chiaia classification) of Adhesive Capsulitis are included in the study.
  • Zuckerman’s diagnostic criteria, for diagnosis of adhesive capsulitis consist of: a) Sudden onset b) Range of motion (ROM) during the active and passive elevation of the shoulder less than 100 c) ROM limitation in external rotation less than 50 % on the contralateral side d) Shoulder pain during night e) Normal radiographical findings.

排除标准

  • Patients who refuse the intervention.
  • who have a history of shoulder surgery.
  • breast surgery.
  • fracture around the shoulder and upper extremities.
  • have a cerebrovascular disease and cervical radiculopathy.
  • uncontrolled diabetes mellitus.
  • who underwent shoulder surgery during study.
  • any other shoulder pathology.
  • contraindicated for SSNB or allergic to local anaesthetic drugs.

结局指标

主要结局

Improvement in range of motion

时间窗: 2nd day, 2nd week, 4th week, 8th week, 12th week post | intervention

次要结局

  • Outcome of Pain(2nd day, 2nd week, 4th week, 8th week, 12th week post)

研究者

发起方
AIIMS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Abdu Raheem KK

AIIMS Bibinagar

研究点 (1)

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