Prediction Frozen Shoulder Validation
Primary Purpose
Frozen Shoulder
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
a standardized physical therapy program
EMSMTA
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder
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.
Sites / Locations
- School and Graduate Institute of Physical Therapy, National Taiwan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
intervention group
control
control-criteria group
Arm Description
intervention group: end-range mobilization/scapular mobilization treatment approach group
Outcomes
Primary Outcome Measures
Range of motion
Disability assessment
Shoulder complex kinematics
Secondary Outcome Measures
Full Information
NCT ID
NCT01157221
First Posted
July 1, 2010
Last Updated
July 2, 2010
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01157221
Brief Title
Prediction Frozen Shoulder Validation
Official Title
Determining Shoulder Kinematics in the Prediction of Progress of Frozen Shoulder Syndrome: a Prediction Method, Validation of the Method, and Clinical Application
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
intervention group: end-range mobilization/scapular mobilization treatment approach group
Arm Title
control
Arm Type
Active Comparator
Arm Title
control-criteria group
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
a standardized physical therapy program
Intervention Description
passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
Intervention Type
Other
Intervention Name(s)
EMSMTA
Intervention Description
end-range mobilization/scapular mobilization treatment approach
Primary Outcome Measure Information:
Title
Range of motion
Time Frame
pre 4 weeks 8 weeks
Title
Disability assessment
Time Frame
pre 4 weeks 8 weeks
Title
Shoulder complex kinematics
Time Frame
pre 4 weeks 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jiu-jenq Lin, PhD
Organizational Affiliation
School and Graduate Institute of Physical Therapy, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School and Graduate Institute of Physical Therapy, National Taiwan University
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
12. IPD Sharing Statement
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Prediction Frozen Shoulder Validation
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