跳至主要内容
临床试验/CTRI/2025/12/098384
CTRI/2025/12/098384尚未招募不适用

Effectiveness of occupation-based intervention on occupational performance and quality of life in frozen shoulder : A randomized controlled trial

Sridhar D2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
2
主要终点
Canadian Occupational Performance Measures (COPM)

研究概览

简要总结

Conservative treatment for frozen shoulder (FS) was studied using various intervention methods including therapeutic exercises and modalities, however, the occupation-based intervention (OBI) was not included in those studies. OBI utilizes activities and occupation as interventions to enhance the occupational performance of an individual’s daily occupation and quality of life in clients with FS is not much explored. The proposed research study can help in choosing OBI for the client with FS and other shoulder conditions. The outcome of this will be added research evidence and facilitate the use of OBI in occupational therapy clinical practice through the home program. Considering current situations OBI home program interventions will be cost-effective and feasible to keep the treatment follow-up. Thus, there is a need to conduct quality research on OBI in clients with FS.

The study will be conducted only after the approval of the IEC-KH and Clinical Trial Registry of India (CTRI).

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
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • The participants diagnosed with a frozen shoulder or primary adhesive capsulitis with or without diabetes in the freezing stage or frozen stage Aged between 35 to 65 years of both gender Participants can read and write the local (Kannada) or English language to follow the study procedures and provide consent to participate in this study, to provide consent to participate in this study or through patient party/informants that includes consent to follow up communication through telephone or get/give clarification related to the research study.

排除标准

  • Secondary conditions associated with shoulder injuries, rotator cuff injury, fractures, shoulder surgeries, and intervention cardiac conditions (CABG, Pacemaker, and other conditions).
  • The participants with other neurological, congenital anomalies, deformities, and psychosocial disorders with frozen shoulder.

结局指标

主要结局

Canadian Occupational Performance Measures (COPM)

时间窗: Time points of evaluation to compare the effectiveness from baseline to 4-6 weeks, and 8-10 weeks

Shoulder Pain and Disability Index (SPADI)

时间窗: Time points of evaluation to compare the effectiveness from baseline to 4-6 weeks, and 8-10 weeks

SF-36 Health-related Quality of Life Questionnaire (SF-36)

时间窗: Time points of evaluation to compare the effectiveness from baseline to 4-6 weeks, and 8-10 weeks

次要结局

  • Shoulder Forward Flexion Reach in the scapular plane (Clinical test)

研究者

发起方
Sridhar D
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sridhar D

Manipal College of Health Professions MAHE Manipal

研究点 (2)

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