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

NCT ID: NCT01813396

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

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.

Detailed Description

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Conditions

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Muscle Stiffness

Keywords

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shoulder muscle stiffness shoulder physical activity range of motion joint mobility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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joint mobilization/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

Group Type EXPERIMENTAL

joint mobilization plus massage

Intervention Type OTHER

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

Group Type EXPERIMENTAL

joint mobilization/shoulder physical activity guide

Intervention Type OTHER

Interventions

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joint mobilization plus massage

Intervention Type OTHER

joint mobilization/shoulder physical activity guide

Intervention Type OTHER

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jiu-jenq Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Natinal Taiwan University Hospital

Locations

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Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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jiu-jenq Lin, PhD

Role: CONTACT

Phone: +886+2+33668126

Email: [email protected]

Facility Contacts

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jiu-jenq Lin, phD

Role: primary

References

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Yang JL, Lin JJ, Huang HY, Huang TS, Chao YW. Shoulder physical activity, functional disability and task difficulties in patients with stiff shoulders: interpretation from RT3 accelerator. Man Ther. 2014 Aug;19(4):349-54. doi: 10.1016/j.math.2014.02.005. Epub 2014 Mar 5.

Reference Type DERIVED
PMID: 24650638 (View on PubMed)

Other Identifiers

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201012075RB

Identifier Type: -

Identifier Source: org_study_id