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Clinical Trials/NCT01813396
NCT01813396UnknownNot Applicable

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

National Taiwan University Hospital1 site in 1 country45 target enrollmentStarted: December 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
45
Locations
1
Primary Endpoint
shoulder physical activity

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

joint mobilization/massage

Experimental

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

Intervention: joint mobilization plus massage (Other)

joint mobilization/shoulder physical activity guide

Experimental

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

Intervention: joint mobilization/shoulder physical activity guide (Other)

Outcomes

Primary Outcomes

shoulder physical activity

Time Frame: right after 12-week treatment

analysis by RT3(shoulder activity measurement device)

Secondary Outcomes

  • Muscle stiffness(right after 12-week treatment)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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