Clinical trial NCT01813396: Prediction of Functional Disability and Clinical Trial in Subjects With Stiff Shoulders
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Stiffness
Keywords: shoulder
muscle stiffness
shoulder physical activity
range of motion
joint mobility
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: shoulder physical activity
timeFrame: right after 12-week treatment
Secondary outcomes:
measure: Muscle stiffness
timeFrame: right after 12-week treatment
Other outcomes:
measure: Joint play assessment
timeFrame: right after 12-week treatment
Locations:
city: Taipei
country: Taiwan
facility: Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital
Study officials:
affiliation: Natinal Taiwan University Hospital
name: jiu-jenq Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.