The Study of Different Treatment Programs for Patients With Frozen Shoulder
Primary Purpose
Frozen Shoulder
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Physical therapy
steroid intraarticular injection
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder focused on measuring Frozen shoulder, pain scale, range of motion(ROM), muscle strength, shoulder arthrography
Eligibility Criteria
Inclusion Criteria:
- Patients with shoulder pain and range of motion limitaiton
Exclusion Criteria:
- Rotator tear
Sites / Locations
- Department of Physical Medicine and Rehabilitation, China Medical University HospitalRecruiting
Outcomes
Primary Outcome Measures
assess the pain scale and range of motion within 6 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT01249040
First Posted
November 24, 2010
Last Updated
November 26, 2010
Sponsor
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01249040
Brief Title
The Study of Different Treatment Programs for Patients With Frozen Shoulder
Official Title
The Study of Different Treatment Programs for Patients With Frozen Shoulder
Study Type
Interventional
2. Study Status
Record Verification Date
September 2004
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
China Medical University Hospital
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to investigate and compare different treatment programs for frozen shoulder by evaluating changes in pain scale and shoulder range of motion(ROM) before and after treatment.
The investigators define frozen shoulder as shoulder pain with ROM limitation,shoulder arthrography demonstration of at least two of the following criteria:(1)reduced joint volume under 10ml; (2)irregular capsular margin;(3)diminished or absent axillary recess.
Afer define diagnosis of frozen shoulder ,patients are randomly assigned to different Subgroups for different treatment programs.Each subgroup consists of ten patients.
Each treatment program performed for 6 consecutive courses with each course consists of 6 days.Total 36 treatment days.
The treatment programs and grouping as follow:
Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise Before treatment,after each consecutive course (6days) of treatment,and at the end of treatment program, the investigators evaluate the range of motion and muscle strength of shoulder flexion,external rotation,abduction and internal rotation. Severity of shoulder pain also evaluated by pain scale before and after treatment program.
The ROM before and after treatment program is compared by paired t-test.The ROM change before and after treatment in different groups compared by analysis of variance(ANOVA). The ROM change after consecutive treatment courses(6 days) are compared by multivariate ANOVA.Pain scale before and after treatment is compared by paired t-test.
Detailed Description
(A) Diagnosis: Patients with shoulder pain onset within 6 months are included in our study to evaluate shoulder range of motion (ROM) in flexion, external rotation,abduction and internal rotation by goniometer(9).Restriction in ROM is noted.Cases with possible diagnosis of frozen shoulder is arranged to receive shoulder arthrography(10,11,12)which is performed by the administration of contrast media(2ml) into joint space,followed by injection of air.Injection is discontinued when resistance is felt.The joint space capacity is defined as the total volume of contrast media and air that could be injected without resistance.All procedures are conducted by the same well experienced radiologist to keep measurement reproducible.The arthrographic findings should met at least two of the following criteria for final diagnosis of frozen shoulder:(1)joint space capacity less than 10ml;(2)irregularity of capsular margin; (3)diminished or absent axillary recess.Once frozen shoulder is confirmed,the patient is randomly arranged to receive a specific treatment program.
(B) Treatment program:
The treatment program and grouping arranged as follow:
Group 1:Physical modalities + therapeutic exercise Group 2:Physical modalities + therapeutic exercise+ intra-articular injection of steroid Gouup 3:Therapeutic exercise
(C) Sample size estimation: We assume α=0.05,power=1-α=0.95,from previous literature(10),change of ROM in flexion, abduction, external rotation, internal rotation before and after treatment was estimated as 40,40,40,20 degrees respectively,,standard deviation was 10,15,10,10 degrees respectively.Therefore,standard effective size was 4,2.6,4,2 respectively.From applied linear statistical models(13)fourth edition,1996,if α=0.05 sample size estimated as 5,7,5,10 Respectively.Therefore,sample size in each group is estimated as 10.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
Frozen shoulder, pain scale, range of motion(ROM), muscle strength, shoulder arthrography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Physical therapy
Intervention Type
Procedure
Intervention Name(s)
steroid intraarticular injection
Primary Outcome Measure Information:
Title
assess the pain scale and range of motion within 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with shoulder pain and range of motion limitaiton
Exclusion Criteria:
Rotator tear
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sui-Foon Lo, MD
Phone
+886-4-22052121
Ext
7390
Email
d4659@www.cmuh.org.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Hsiu-Chen Lin, MS, PT
Phone
+886-4-22053366
Ext
3117
Email
hclin@mail.cmu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sui-Foon Lo, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, China Medical University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, China Medical University Hospital
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sui-Foon Lo, MD
Phone
+886-4-22062121
Ext
7390
Email
d4659@www.cmuh.org.tw
12. IPD Sharing Statement
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