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临床试验/CTRI/2024/07/069829
CTRI/2024/07/069829尚未招募3 期

Effect of Rotator Cuff Unloading in Patients with Arthroscopic Rotator Cuff Repair on Pain, Function, Kinesiophobia and Cuff Diameter- A Pilot Randomized Controlled Trial.

MGM Institute of Physiotherapy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Pain

研究概览

简要总结

Patients with Arthroscopic Rotator Cuff Repair will be included in the study trial if they met the inclusion criteria. The written and oral consent of all patients will be taken, and procedure will be explained. Demographic data will be noted. Baseline data which includes Pain, Function, Kinesiophobia and Cuff Diameter will be assessed. The patients will be randomly divided into two study groups intervention group and control group. The patients will receive intervention as per the group allocation for 4 weeks. The intervention group will receive Unloading exercises for the rotator cuff in addition to the conventional physiotherapy whereas the control group will receive conventional physiotherapy only. Rotator Cuff Unloading Exercise Program will include exercises divided into 4 groups namely (Semi-closed kinetic chain elevation, Deltoid reeducation, Assisted arm elevation and Exercise for scapular control). Patients will perform 1 exercise from each group and progression will be made based on pain experienced during the program. Only in the presence of symptoms < 3 points on the 11-point numeric pain rating scale, a progression towards the next exercise or load is allowed. All exercises will be given 3 sessions/week for 4 weeks. Conventional Physiotherapy includes  TENS, AROM and PROM exercises, gentle joint oscillations, scapular control exercises, pendulum exercise,  joint mobilization ( grade 1 and 2- pain relief, glenohumeral traction, anterior and posterior translational glides) which will be given 3 sessions/week for 4 weeks. Outcome measures will be assessed pre and post intervention period of 4 weeks and will include (NPRS, Kinesiophobia using TAMPA scale, function of upper extremity using DASH and USG). Statistical analysis of the collected data will be done. Conclusion will be established based on the obtained results of the study.

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
25.00 Year(s) 至 55.00 Year(s)(—)
性别
All

入选标准

  • Both male and females
  • Age group between 25-55 years.
  • Arthroscopic repair of any rotator cuff muscle
  • Analgesics.

排除标准

  • Central nervous system disorder
  • Peripheral nerve disorder
  • Adhesive capsulitis
  • Systemic inflammatory diseases
  • Shoulder joint osteoarthritis.

结局指标

主要结局

Pain

时间窗: Pre and Post Intervention Period (4 week)

次要结局

  • Function(Pre and Post Intervention Period (4 week))
  • Kinesiophobia(Pre and Post Intervention Period (4 week))
  • Cuff Diameter(Pre and Post Intervention Period (4 week))

研究者

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

Dr Manasi Mandar Waman

MGM Institute of Physiotherapy, Aurangabad

研究点 (1)

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