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
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
Mongjam Anganba Khumancha
Regional Institute of Medical Sciences, Imphal
