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

NCT01813396 | Unknown DMC

• 1 other identifier: 201012075RB
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Stiffness

Keywords

shoulder; muscle stiffness; shoulder physical activity; range of motion; joint mobility

Outcome Measures

Primary Outcomes (1)

• shoulder physical activity

  analysis by RT3(shoulder activity measurement device)

  right after 12-week treatment

Secondary Outcomes (1)

• Muscle stiffness

  right after 12-week treatment

Other Outcomes (1)

• Joint play assessment

  right after 12-week treatment

Study Arms (2)

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

Other: joint mobilization plus massage

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

Other: joint mobilization/shoulder physical activity guide

Interventions

joint mobilization plus massage OTHER

joint mobilization/massage

joint mobilization/shoulder physical activity guide OTHER

joint mobilization/shoulder physical activity guide

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \[1\] 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

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

Taipei, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 24650638 DERIVED

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• jiu-jenq Lin, PhD

  Natinal Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jiu-jenq Lin, PhD

CONTACT

+886+2+33668126; jiujlin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 19, 2013
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

TW (1)