Oral Corticosteroids Versus Exercises On Treatment Of Frozen Shoulder,
1 other identifier
interventional
33
1 country
2
Brief Summary
The purpose of this study is to compare the efficacy of exercise and oral corticosteroids the treatment of a FS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2022
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedNovember 1, 2022
October 1, 2022
9 months
January 16, 2022
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline,6th week and 12th week
Secondary Outcomes (4)
Change from baseline in function on ASES at 6th and 12th week
Baseline,6th week and 12th week
Change from baseline in range of motion (ROM) at 6th and 12th week
Baseline,6th week and 12th week
Change from baseline in depression and anxiety on HADS at 6th and 12th week
Baseline,6th week and 12th week
Change from baseline in pain on VAS at 6th and 12th week
Baseline,6th week and 12th week
Study Arms (2)
Corticosteroid
EXPERIMENTALThe participants will receive prednisolone for four weeks.
Exercise
ACTIVE COMPARATORThe participants will receive joint mobilization techniques, stretching and home exercise.
Interventions
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.
The exercise program will be performed two times per week for six weeks for 12 sessions.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- bilateral frozen shoulder
- rotator cuff tear
- previous corticosteroid injection at the affected shoulder within 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Istanbul Faculty Medicine
Istanbul, Fatih, 34147, Turkey (Türkiye)
İÜC Sağlık Bilimleri Fakültesi
Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Derya Çelik
Istanbul University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant; Principal Investigator
Study Record Dates
First Submitted
January 16, 2022
First Posted
January 28, 2022
Study Start
January 25, 2022
Primary Completion
October 10, 2022
Study Completion
October 20, 2022
Last Updated
November 1, 2022
Record last verified: 2022-10