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临床试验/CTRI/2024/01/061843
CTRI/2024/01/061843进行中(未招募)不适用

Effectiveness of Bilateral sensorimotor training on upper quadrant function and quality of life in individuals with unilateral rotator cuff related shoulder pain - A randomized controlled trial

Kavitha Vishal1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年2月3日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
80
试验地点
1
主要终点
Upper limb function

研究概览

简要总结

Primary objective: To evaluate the effectiveness of a bilateral sensorimotor training program compared to standard training on upper quadrant function (DASH) and quality of life (WORC) in Individuals with unilateral RCRSP.

 Secondary objective: To compare the effectiveness of bilateral sensorimotor training compared to standard training on pain intensity (NPRS), pain sensitivity (PPT), active range of motion (ROM), shoulder muscle strength (isometric muscle strength), shoulder joint proprioception (passive to active joint position error), and shoulder function (CMS score).

 Interventions -both the groups

Both the groups will undergo clinical examination including a thorough subjective and physical examination of the shoulder and the spine by the treating physiotherapist.

Participants will be asked about the burden of shoulder pain using a semi- structured interview guide until thematic saturation. Data will be analyzed qualitatively using themes and subthemes. The interview will be conducted in English and Kannada. Themes derived will be used to understand the burden and lived experience of shoulder pain.

The treatment protocol will be pragmatically delivered based on the clinical examination findings. The experimental group will receive bilateral sensorimotor training (exercises on the involved and the uninvolved side). The control group will receive standard training (exercises only on the involved side). In addition, both the groups will receive education, modalities (heat/cold) stretching exercises, posture correction and mobilization of the glenohumeral joint if indicated.   To ensure uniformity in prescription of intervention both the groups will receive same number of sessions and dosages.

Both groups will receive a total of 10 supervised sessions over the 12-week period, with each session lasting 45 minutes. The supervised sessions will be scheduled once per week for the first six weeks, followed by four additional sessions spread over the remaining six weeks. In addition to the supervised sessions, participants will perform a home exercise program independently once per day, six days a week, for 12 weeks as per their group assignment

Experimental group

Participants in the EG received bilateral sensorimotor training. They will perform strengthening, motor control, and proprioceptive exercises on the involved and the uninvolved side simultaneously.

The exercise program will be structured into three progressive stages of increasing difficulty, determined by the degree of humeral elevation and greater activity of the RC.Each stage will have general strengthening, rotator cuff-specific strengthening, motor control training, and proprioceptive exercises.

Control group

Participants in the CG performed standard training on the involved side. The intervention will be usual care provided to patients with RCRSP, including strengthening and/or motor control exercise and proprioceptive exercises, based on the physical examination findings performed only on the involved side. Exercise prescription will be guided by the participant’s adaptive response and pain behaviour of the involved limb.

Outcomes will be assessed at three time points, baseline, 6 weeks and 12 weeks

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
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Complains of shoulder pain unilaterally Positive Hawkins kennedy Positive Neer impingememt Postive external rotation stress test.

排除标准

  • Bilateral shoulder pain Adhesive capsultis Recent surgery Cardiopulmaory, inflammatory and neurological conditions affecting the upper extremity Neck pain.

结局指标

主要结局

Upper limb function

时间窗: Baseline and 12 weeks

Quality of Life

时间窗: Baseline and 12 weeks

次要结局

  • shoulder pain during rest and activity(Shoulder muscle strength)

研究者

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

Kavitha Vishal

Manipal Academy of Higher Education

研究点 (1)

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