跳至主要内容
临床试验/CTRI/2024/01/062152
CTRI/2024/01/062152尚未招募2 期

EFFECTIVENESS OF ULTRASOUND GUIDED CRYOABLATION OF SUPRASCAPULAR NERVE IN COMPARISON WITH STEROID AND LOCAL ANAESTHETIC BLOCK FOLLOWED BY MANIPULATION FOR REDUCTION OF PAIN AND FUNCTIONAL DISABILITY IN PATIENT WITH ADHESIVE CAPSULITIS OF THE SHOULDER: A RANDOMISED CONTROLLED TRIAL

REGIONAL INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2024年2月3日最近更新:

试验速览

阶段
2 期
状态
尚未招募
入组人数
32
试验地点
1
主要终点
Shoulder pain and disability measured by SPADI and VAS

研究概览

简要总结

Adhesive capsulitis is an idiopathic, painful, regular restriction of all shoulder movements with normal radiographs and is self-limiting in nature, affecting activities of daily living (ADL) and reducing the quality of life. Treatment should aim to relieve pain, improve function, limit disabilities and improve quality of life but the best treatment is still subject to debate. Due to the recent emergence of the effectiveness of cryoablation of nerves in the treatment of various painful musculoskeletal conditions and the background of inconclusive evidence for treatment modalities for AC, and due to the limited number of studies available for cryoablation in the management of adhesive capsulitis, there is a need to examine the role of cryoablation of suprascapular nerve in adhesive capsulitis. Thus a randomized controlled trial shall be conducted in the Department of Physical Medicine and Rehabilitation, RIMS, Imphal to compare the effectiveness of ultrasound-guided cryoablation of suprascapular nerve with steroid and local anaesthetic for reduction of pain and functional disabilities in patients with adhesive capsulitis of the shoulder. The outcome variables will be measured at baseline and 1, 4, 12 and 24 weeks post-intervention follow-up. For calculation, the Chi-square test, independent t-test, and repeated measure ANOVA will be used and a p-value <0.05 will be considered statistically significant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
40.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age group 40-60 years
  • Diagnosed case of stage II and stage III adhesive capsulitis based on clinical staging
  • Patients who are willing to comply with the study and follow-up assessments.

排除标准

  • Any recent febrile or infectious disease
  • Patients with osteoporosis
  • Patients with a history of fracture around shoulder joint or dislocations of shoulder joint
  • Malignancy
  • Autoimmune and haematological disorders
  • Impaired cognition 7.

结局指标

主要结局

Shoulder pain and disability measured by SPADI and VAS

时间窗: At the end of 1st week, 4th week, 12th week and 24th week

次要结局

  • Functional outcome measured by ROM of shoulder(At the end of 1st week, 4th week, 12th week and 24th week)

研究者

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

Mongjam Anganba Khumancha

Regional Institute of Medical Sciences, Imphal

研究点 (1)

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