The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frozen Shoulder
- Sponsor
- Istanbul University
- Enrollment
- 50
- Primary Endpoint
- Change from baseline pain score on Visual Analog Scale(VAS)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this interventional study is to compare the outcomes of two different injection aprroaches in patients with frozen shoulder. The main questions it aims to answer are:
- Is hydrodilatation better than intraarticular corticosteroid injection?
- Is there any prognostic factors that will help clinicians guide their decision making when choosing between these two treatments?
Participans will receive an injection(cortcosteroid and local anesthetics alone or with hydrodilatation-corticosteroid and local anesthetics plus sterile saline solution) and then they will follow a rehabilitation program.
Investigators
Fatmanur Yegin
Research Assistant Doctor
Istanbul University
Eligibility Criteria
Inclusion Criteria
- •Patients who fulfill the diagnostic criteria for frozen shoulder
- •Agree to participate in the study
- •Having the opportunity to follow up for at least 3 months
Exclusion Criteria
- •Refusing to participate in the study
- •History of shoulder injection in the last 3 months
- •Having diabetes mellitus
- •Presence of comorbidities that contraindicate injection therapy, such as bleeding diathesis
- •Known history of allergy or anaphylaxis to drugs used in treatment
Outcomes
Primary Outcomes
Change from baseline pain score on Visual Analog Scale(VAS)
Time Frame: Baseline, 1 week, 1 month, 3 months
Pain scored according to VAS; between 0(no pain) to 10(worst pain)
Change in Shoulder Pain and Disability Index(SPADI) scores
Time Frame: Baseline, 1 month, 3 months
Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
Secondary Outcomes
- Change in Range of Movement(ROM)(Baseline, 1 week, 1 month, 3 months)
- Proprioception(Active position sense- joint position error)(Baseline, 3 months)
- Shoulder Strength(Baseline, 3 months)
- Ultrasound Parameters(Baseline, 1 month, 3 months)
- Changes in Depression Score(Baseline, 1 months, 3 months)
- Changes in Life Quality Score(Baseline, 1 month, 3 months)
- Treatment Satisfaction(3 months)