Prediction Frozen Shoulder Validation

Study Overview
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Brief Summary
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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.

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

Conditions
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Frozen Shoulder

Intervention / Treatment
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* Other: a standardized physical therapy program
* Other: EMSMTA


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>intervention group: end-range mobilization/scapular mobilization treatment approach group | Other: EMSMTA<br>* end-range mobilization/scapular mobilization treatment approach<br>|
| Active Comparator: control<br> | Other: a standardized physical therapy program<br>* passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises<br>|
| Sham Comparator: control-criteria group<br> | Other: a standardized physical therapy program<br>* passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion |  | pre 4 weeks 8 weeks | 
| Disability assessment |  | pre 4 weeks 8 weeks | 
| Shoulder complex kinematics |  | pre 4 weeks 8 weeks |