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

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

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 Overview

• Status: Unknown
• Conditions: Muscle Stiffness
• Intervention / Treatment: Other: joint mobilization plus massage; Other: joint mobilization/shoulder physical activity guide

• Study Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Physical Therapy Center or Department of Physical Medicine and Rehabilitation at National Taiwan University Hospital
    • Contact: jiu-jenq Lin, phD; Phone Number: 886-2-33668126; Email: jiujlin@ntu.edu.tw
    • Principal Investigator: Jiu-jenq Lin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: joint mobilization plus massage
Experimental: 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	Other: joint mobilization/shoulder physical activity guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
shoulder physical activity	analysis by RT3(shoulder activity measurement device)	right after 12-week treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle stiffness	analysis by myotonometer(muscle stiffness measurement device)	right after 12-week treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Joint play assessment	joint play scale measured by physical therapist	right after 12-week treatment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: jiu-jenq Lin, PhD, Natinal Taiwan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: February 20, 2013
• First Submitted That Met QC Criteria: March 14, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Estimate): November 1, 2013
• Last Update Submitted That Met QC Criteria: October 31, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: shoulder; muscle stiffness; range of motion; shoulder physical activity; joint mobility
• Other Study ID Numbers: 201012075RB