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

Muscle Stiffness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01813396
• Other study ID #: 201012075RB
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2013
• Last updated: October 31, 2013
• Start date: December 2011

Study information

• Verified date: October 2013
• Source: National Taiwan University Hospital
• Contact: jiu-jenq Lin, PhD
• Phone: +886+2+33668126
• Email: jiujlin[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Stiffness

Intervention

Other:
• joint mobilization plus massage

• joint mobilization/shoulder physical activity guide

Locations

Country	Name	City	State
Taiwan	Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Joint play assessment	joint play scale measured by physical therapist	right after 12-week treatment	No
Primary	shoulder physical activity	analysis by RT3(shoulder activity measurement device)	right after 12-week treatment	No
Secondary	Muscle stiffness	analysis by myotonometer(muscle stiffness measurement device)	right after 12-week treatment	No