Prediction Frozen Shoulder Validation

Frozen Shoulder Clinical Trial

Official title:

Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157221
• Other study ID #: 200612088R
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 1, 2010
• Last updated: July 2, 2010
• Start date: August 2006
• Est. completion date: June 2010

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Background: Few studies have examined the predictors of the clinical course of subjects with frozen shoulder syndrome or explained the persistence of symptoms after appropriate therapy. Altered shoulder kinematics may predispose subjects to subacromial impingement, rotator cuff tendonitis, altered shoulder joint forces, and possible degenerative changes. Subsequently, a more difficult and chronic course of frozen shoulder syndrome may develop.

Objective: The purposes of this study are: (1) to develop a prediction method for determining altered shoulder kinematics and associated muscular activities which are associated with the chronicity of frozen shoulder dysfunction, and (2) to validate this prediction method and analyze the impact of the method on clinical behavior.

Design: For the first year, a prospective study will be conducted to develop a prediction method that will identify impaired shoulder kinematics associated with the degree of symptom-related functional disability in patients with frozen shoulder syndrome. For the second and third years, validation of the proposed prediction method will determine whether altered shoulder kinematics and associated muscular activities subject to intervention meet the prediction criteria and demonstrate improvement in their follow-up, which will be shown to improve decision making in clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 50% loss of passive movement of the shoulder joint relative to the nonaffected side, in 1 or more of 3 movement directions (i.e., forward flexion, abduction in the frontal plane, or external rotation in 0° of abduction);

• 13-15 and duration of complaints of at least 3 months.

Exclusion Criteria:

• a history of stroke with residual upper-extremity involvement,

• diabetes mellitus,

• rheumatoid arthritis,

• rotator cuff tear,

• surgical stabilization of the shoulder,

• osteoporosis, or

• malignancies in the shoulder region.

• subjects who had pain or disorders of the cervical spine, elbow, wrist, or hand, or who had pain radiating from the shoulder to the arm, were also excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bursitis
• Frozen Shoulder

Intervention

Other:
• a standardized physical therapy program
passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
• EMSMTA
end-range mobilization/scapular mobilization treatment approach

Locations

Country	Name	City	State
Taiwan	School and Graduate Institute of Physical Therapy, National Taiwan University	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
Primary	Range of motion		pre 4 weeks 8 weeks	No
Primary	Disability assessment		pre 4 weeks 8 weeks	No
Primary	Shoulder complex kinematics		pre 4 weeks 8 weeks	No