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

Not Applicable

• Conditions: Muscle Stiffness
• Interventions: Other: joint mobilization plus massage; Other: joint mobilization/shoulder physical activity guide

• Registration Number: NCT01813396
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-02-20
• Primary Completion: 2013-03
• Study First Submitted QC: 2013-03-14
• Study First Posted: 2013-03-19
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
joint mobilization/massage	joint mobilization plus massage	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
joint mobilization/shoulder physical activity guide	joint mobilization/shoulder physical activity guide	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

Primary Outcome Measures

Name	Time	Method
shoulder physical activity	right after 12-week treatment	analysis by RT3(shoulder activity measurement device)

Secondary Outcome Measures

Name	Time	Method
Muscle stiffness	right after 12-week treatment	analysis by myotonometer(muscle stiffness measurement device)

Trial Locations

Locations (1)

Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan