Prediction Frozen Shoulder Validation

NCT ID: NCT01157221

Last Updated: 2010-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-06-30

Brief 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.

Conditions

Frozen Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

intervention group

intervention group: end-range mobilization/scapular mobilization treatment approach group

Group Type: EXPERIMENTAL

EMSMTA

Intervention Type: OTHER

end-range mobilization/scapular mobilization treatment approach

control

Group Type: ACTIVE_COMPARATOR

a standardized physical therapy program

Intervention Type: OTHER

passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises

control-criteria group

Group Type: SHAM_COMPARATOR

a standardized physical therapy program

Intervention Type: OTHER

passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises

Interventions

a standardized physical therapy program

passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises

Intervention Type: OTHER

EMSMTA

end-range mobilization/scapular mobilization treatment approach

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

School of Physical Therapy, National Taiwan University

Principal Investigators

jiu-jenq Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

School and Graduate Institute of Physical Therapy, National Taiwan University

Locations

School and Graduate Institute of Physical Therapy, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

200612088R

Identifier Type: -

Identifier Source: org_study_id