Back to resultsOral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Primary Purpose
Frozen Shoulder
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Corticosteroid
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Frozen Shoulder focused on measuring frozen shoulder, adhesive capsulitis, corticosteroid, exercise
Eligibility Criteria
Inclusion Criteria:
- between ages 18-60 years
- loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
- The pain VAS more than 7 (10 in total)
Exclusion Criteria:
- bilateral frozen shoulder
- rotator cuff tear
- previous corticosteroid injection at the affected shoulder within 3 months
Sites / Locations
- Istanbul Faculty Medicine
- İÜC Sağlık Bilimleri Fakültesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Corticosteroid
Exercise
Arm Description
The participants will receive prednisolone for four weeks.
The participants will receive joint mobilization techniques, stretching and home exercise.
Outcomes
Primary Outcome Measures
Change from baseline in function on DASH at 6th and 12th week
The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Secondary Outcome Measures
Change from baseline in function on ASES at 6th and 12th week
The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
Change from baseline in range of motion (ROM) at 6th and 12th week
The joint's range of motion is the distance that the joint can extend.
Change from baseline in depression and anxiety on HADS at 6th and 12th week
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring.
Change from baseline in pain on VAS at 6th and 12th week
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05212740
Brief Title
Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Official Title
Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
Detailed Description
After being informed about the study, all patients giving written informed and meet the inclusion criteria will be randomized a double blind manner in a 1:1 (participant and investigator) to oral corticosteroids or exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder
Keywords
frozen shoulder, adhesive capsulitis, corticosteroid, exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Corticosteroid
Arm Type
Experimental
Arm Description
The participants will receive prednisolone for four weeks.
Arm Title
Exercise
Arm Type
Active Comparator
Arm Description
The participants will receive joint mobilization techniques, stretching and home exercise.
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
Intervention Description
The treatment will initiate with a dose of 0.5 mg/kg/day prednisolone for two weeks and the dose will halve in the next two weeks.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
The exercise program will be performed two times per week for six weeks for 12 sessions.
Primary Outcome Measure Information:
Title
Change from baseline in function on DASH at 6th and 12th week
Description
The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.
Time Frame
Baseline,6th week and 12th week
Secondary Outcome Measure Information:
Title
Change from baseline in function on ASES at 6th and 12th week
Description
The ASES score is a 10-item measure of shoulder pain and function. Pain is assessed on a 10-cm visual analog scale (VAS) and accounts for 50% of the total score. The remaining 50% of the score is determined by the responses to 10 4-point Likert-scale questions related to physical function.
Time Frame
Baseline,6th week and 12th week
Title
Change from baseline in range of motion (ROM) at 6th and 12th week
Description
The joint's range of motion is the distance that the joint can extend.
Time Frame
Baseline,6th week and 12th week
Title
Change from baseline in depression and anxiety on HADS at 6th and 12th week
Description
HADS is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression. HADS scoring was done before and after low-vision consultation to see whether there was a change in the scoring.
Time Frame
Baseline,6th week and 12th week
Title
Change from baseline in pain on VAS at 6th and 12th week
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain.
Time Frame
Baseline,6th week and 12th week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between ages 18-60 years
loss of passive motion of the glenohumeral joint greater than 25% or 30 in at least 2 directions (flexion, external rotation, and internal rotation) compared with the contralateral side
The pain VAS more than 7 (10 in total)
Exclusion Criteria:
bilateral frozen shoulder
rotator cuff tear
previous corticosteroid injection at the affected shoulder within 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Derya Çelik
Organizational Affiliation
Istanbul University
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul Faculty Medicine
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34147
Country
Turkey
Facility Name
İÜC Sağlık Bilimleri Fakültesi
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
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Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
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