Frozen Shoulder, Shoulder Capsulitis, Shoulder Pain
Conditions
Keywords
hydrodilatation, hydrodistension, ultrasound
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.
Interventions
5 ml blind intra-articular corticosteroid injection
OTHERUltrasound Guided Hydrodilatation with corticosteroid injection
15 ml intra-articular injection to shoulder via anterior approach under ultrasound guidance
Sponsors
Istanbul University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two-arm study with one hydrodilatation group compared with the standart treatment group(cortisteroid injection)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Ultrasound Parameters | Baseline, 1 month, 3 months | Coracohumeral ligament(CHL) thickness, axillary pouch(AP) thickness, elastography of deltoid muscle(anterior, middle, and posterior) |
Contacts
Primary ContactFatmanur Yegin
Outcome results
None listed