Prediction of Functional Disability and Clinical Trial in Subjects With Stiff Shoulders

Study Overview
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Brief Summary
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First, the purpose of the first year study will examine the joint capsule/muscular and shoulder physical activity hypotheses related to ROM deficits as well as functional disability in subjects with Stiff shoulders. Second, the purpose of the second and third year study will investigate the long-term effect of 12-week joint mobilization, 12-week joint mobilization plus soft tissue mobilization/massage, and 12-week joint mobilization plus soft tissue mobilization/massage with appropriate shoulder physical activity guide on subjects with Stiff shoulders. Subjects: First year: thirty subjects with Stiff shoulders will be recruited. Second and third years: forty-five subjects with Stiff shoulders for one year follow-up. Methods: For the measurement outcomes; functional disability, rotation range of motion, joint mobility, muscle stiffness, and shoulder physical activity will be measured by self-reported Flexi-level Scale of Shoulder Function or performance-based motion analysis, goniometer, uni-axis load cell and electromagnetic tracking sensor, myotonometer, and accelerometers, respectively.

Official Title
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Prediction of Functional Disability and Randomized Clinical Trial in Subjects With Stiff Shoulders: Joint Mobility, Range of Motion, Muscle Stiffness, and Shoulder Physical Activity

Conditions
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Muscle Stiffness

Intervention / Treatment
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* Other: joint mobilization plus massage
* Other: joint mobilization/shoulder physical activity guide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: [1] a limited ROM of flexion, abduction, and rotation (ROM < 20% to the sound side); and [2] pain and stiffness in the shoulder region for at least 3 months. Exclusion Criteria: surgery on the particular shoulder, [2] rheumatoid arthritis, [3] stroke with residual shoulder involvement, [4] fracture of the shoulder complex, [5] rotator cuff deficiency, and [6] resting pain, intolerable pain, or muscle spasm during active and/or passive motion.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: joint mobilization/massage<br>joint mobilization: End-range joint mobilization massage: massage twice a week on the identified muscle(s) of the involved shoulder about 6 minutes for each muscle for 3 months. The techniques of massage include petrissage for 3 minutes and rolling for 3 minutes of soft tissues | Other: joint mobilization plus massage<br> <br> |
| Experimental: joint mobilization/shoulder physical activity guide<br>joint mobilization: End-range joint mobilization shoulder physical activity guide: shoulder physical activity guide is based on the appropriate cut off activity level identified in the predication rule | Other: joint mobilization/shoulder physical activity guide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| shoulder physical activity | analysis by RT3(shoulder activity measurement device) | right after 12-week treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle stiffness | analysis by myotonometer(muscle stiffness measurement device) | right after 12-week treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder, muscle stiffness, shoulder physical activity, range of motion, joint mobility