The Effects of Two Different Treatment Protocols on Shoulder Function, Quality of Life, and Ultrasound Parameters in Patients With Frozen Shoulder
- Conditions
- Frozen ShoulderShoulder PainShoulder Capsulitis
- Interventions
- Other: Ultrasound Guided Hydrodilatation with corticosteroid injectionOther: Intra-articular corticosteroid injection
- Registration Number
- NCT05956171
- Lead Sponsor
- Istanbul University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ultrasound Guided Hydrodilatation with corticosteroid injection Ultrasound Guided Hydrodilatation with corticosteroid injection 15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance Drugs: * betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) * prilocaine hydrochloride %2 (4 ml) * Sodium chloride %0,9 (10 ml) Blind intra-articular corticosteroid injection Intra-articular corticosteroid injection 5 ml intra-articular blind injection to shoulder via posterior approach Drugs: * betamethasone dipropionate/ betamethasone sodium phosphate(diprospan) (5 mg+2mg/ml) (1 ml) * prilocaine hydrochloride %2 (4 ml)
- Primary Outcome Measures
Name Time Method Change from baseline pain score on Visual Analog Scale(VAS) 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 Baseline, 1 month, 3 months Scored between 0-10 ; 0 means no pain and disability and 10 means the worst pain and disability
- Secondary Outcome Measures
Name Time Method Change in Range of Movement(ROM) Baseline, 1 week, 1 month, 3 months Range of shoulder movements assessed with digital inclinometer in sittting and lying positions
Proprioception(Active position sense- joint position error) Baseline, 3 months Shoulder joint is positioned in 30 degree flexion and 15 degree internal and external rotation in lying position, patient is asked to position their joints and errors in degrees noted
Shoulder Strength Baseline, 3 months Measured with cybex isokinetic dinamometer, shoulder flexion/extension and shoulder internal/external rotation
Ultrasound Parameters Baseline, 1 month, 3 months Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior)
Changes in Depression Score Baseline, 1 months, 3 months measured by Beck's Depression Inventory(between 0 to 40), 0 means no depression and 40 means severe depression
Changes in Life Quality Score Baseline, 1 month, 3 months Items from the SF-36 (Short Form 36) survey, between 0(worst) to 100(best)
Treatment Satisfaction 3 months Global Improvement and Satisfaction Score, between 1 to 5, 1 very dissatisfied, and 5 very satisfied