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临床试验/CTRI/2022/08/044519
CTRI/2022/08/044519已完成不适用

Comparison of the analgesic efficacy of intra articular steroid injections and combination therapy with supra-scapular nerve block in patients with adhesive capsulitis of the shoulder joint

JIPMER1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
JIPMER
入组人数
96
试验地点
1
主要终点
To compare the Shoulder Pain and Disability score (SPADI) among the patients receiving intra-articular steroid injection alone combination of intra-articular steroid injection and supra scapular nerve block and physiotherapy alone.

研究概览

简要总结

Adhesive capsulitis, or “frozen shoulder,†is a condition of varying severity characterized by the gradual development of global limitation of active and passive shoulder motion. Though considered a self-limited disease, some residual stiffness may remain even after the resolution of capsular inflammation, thereby severely impairing the quality of life of these patients. Thus, early diagnosis and treatment of this condition provides favorable outcome, i.e., symptomatic relief and early improvement in the range of movements (ROM). 

Treatment modalities for adhesive capsulitis include medication, intra-articular steroid injection, nerve blocks, physiotherapy, manipulation under anaesthesia and capsular release. Currently there is no consensus as to the most efficacious treatment.  In our study, we propose to find and compare the effects of intra-articular steroid injections alone and in combination therapy with supra-scapular nerve block in patients with adhesive capsulitis of the shoulder joint.

Few observational studies have studied the efficacy of intra-articular steroid injections and supra-scapular nerve block in adhesive capsulitis. There are no available RCTs, in literature, that have compared the effects of these two modalities singly or in combination therapy among the Indian population.

We propose that use of intra-articular steroid injections, or combination therapy with supra-scapular nerve block together with physical therapy will provide cost effective and quicker outcomes in terms of symptomatic relief and overall improvement in quality of life. The results of this study will help us to choose an ideal intervention technique for patients with adhesive capsulitis.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • •Patients with diffuse shoulder pain and restriction of movement for more than 3 weeks duration and clinically diagnosed to have adhesive capsulitis.

排除标准

  • •Cardiopulmonary disease 2) Cervical disc lesions 3) Fractures of ipsilateral limb 4) Calcific tendonitis 5) Bilateral adhesive capsulitis 6) Bleeding disorders 7) Long term steroid therapy 8) Allergy to study drugs.

结局指标

主要结局

To compare the Shoulder Pain and Disability score (SPADI) among the patients receiving intra-articular steroid injection alone combination of intra-articular steroid injection and supra scapular nerve block and physiotherapy alone.

时间窗: Pre intervention | post intervention day 0 | post intervention week 2 | post intervention week 6 | post intervention week 12

次要结局

  • Comparison of Quality of Life using SF-12(Pre intervention)
  • Comparison of need for pain medication requirement using Medication Quantification Scale (MQS 3)(Pre intervention)
  • Comparison of Disabilities of the Arm, Shoulder and Hand (Quick DASH) score(Pre intervention)
  • Comparison of Range of movements using Constant shoulder score(Pre intervention)
  • Comparison of pain using VAS score(Pre intervention)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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