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临床试验/CTRI/2024/06/068592
CTRI/2024/06/068592尚未招募4 期

Comparison of the clinical outcome between manipulation and hydrodilatation among patients with adhesive capsulitis of shoulder receiving intra-articular steroid injection - A Randomised controlled trial

Pondicherry Institute of Medical Sciences1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2024年6月26日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
52
试验地点
1
主要终点
To compare the pain outcome using VAS score, shoulder disability by SPADI score

研究概览

简要总结

This study will be carried out after getting approval from institutional research and ethical committee. 52 patients undergoing manipulation under anaesthesia who fulfils the inclusion and without any exclusion criteria will be randomized into two groups using computer generated random numbers. .A pre anaesthetic evaluation will be done for all the patients. The informed and written consent will be obtained after explaining the procedure to all patients. Patient were then divided into two groups using block randomization. Case assigned to group A will receive intra articular steroid and manipulation under anaesthesia whereas in group B will receive intra-articular steroid injection and hydrodilation using normal saline.  In both the group of patient the VAS and SPADI score were recorded at the time of presentation and post the intervention. Both the groups will undergo Physiotherapy and home exercise programme. And participants will be followed up by recommendation of usage of home diary for ensuring the adherence of physiotherapy exercises. Follow up of the case will be done post operatively, 3 weeks, 6 weeks and 12 weeks.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Unilateral frozen shoulder 2) Primary frozen shoulder, with no relief after physiotherapy and analgesics for a period of 3 months.
  • Loss of passive motion of the glenohumeral joint of 30 degree in at least 2 directions ( Flexion, extension, external rotation, internal rotation , abduction, adduction ) 4) Patient more than 18 years of age.

排除标准

  • Secondary frozen shoulder 2)Patient with any injury in the ipsilateral shoulder joint 3)Rotator cuff tear / tendinitis 4)Previous history of intra articular steroid injection within three months 5)Patient with glenohumeral joint arthritis – Confirmed with xrays 6) Skin lesions over shoulder region.

结局指标

主要结局

To compare the pain outcome using VAS score, shoulder disability by SPADI score

时间窗: Pain and disability is assessed on 3 weeks, 6 weeks and 12 weeks.

次要结局

  • Assess the improvement in disability in patient suffering from adhesive capsulitis(Disability is assessed on 3 weeks, 6 weeks and 12 weeks.)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Anitha A

Pondicherry Institute of Medical Sciences

研究点 (1)

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