Adhesive Capsulitis of the Shoulder
Conditions
Keywords
adhesive capsulitis, capsular distension, rehabilitation, corticosteroid
Brief summary
Adhesive capsulitis is a common and disabling shoulder condition characterized by pain and progressive limitation of range of motion. Capsular distension and intra-articular corticosteroid injection are commonly used therapeutic options, often combined with rehabilitation, but their comparative effectiveness remains debated. The objective of this randomized controlled trial is to compare the efficacy and tolerance of ultrasound-guided capsular distension combined with rehabilitation versus intra-articular corticosteroid injection combined with rehabilitation in patients with adhesive capsulitis. Outcomes will include shoulder pain, range of motion, functional disability, patient satisfaction, and procedure-related complications, assessed at short, mid, and long-term follow-up.
Interventions
PROCEDUREcapsular distension
Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
PROCEDUREBetamethasone (Diprostene®) Injection
Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.
Sponsors
Faculty of Medicine of Tunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 80 years * Ability to provide informed consent * Shoulder pain with Visual Analog Scale (VAS) ≥ 40/100 * Limitation of external rotation \< 45° or \< 50% compared to the contralateral side * Clinically diagnosed adhesive capsulitis with normal shoulder radiography
Exclusion criteria
* Rotator cuff tear * Previous shoulder surgery * Cervico-brachial neuralgia * Pregnancy or breastfeeding * Poorly controlled diabetes * Coagulation disorders or anticoagulant therapy with INR \> 3 * Allergy to lidocaine * Inflammatory rheumatic diseases * Severe cardiovascular or hematological diseases * Active infection or immunodeficiency * Severe psychiatric disorders * Recent shoulder rehabilitation (within 1 week) * Intra-articular corticosteroid injection or hyaluronic acid injection within the last 6 months * Refusal to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain Intensity (Visual Analog Scale) | Baseline, 1 month, 3 months, and 6 months | Change in shoulder pain intensity assessed using a 100-mm Visual Analog Scale (VAS), where 0 indicates no pain and 100 indicates the worst imaginable pain. |
| Shoulder range of motion | Baseline, 1 month, 3 months, and 6 months | Change in active shoulder range of motion measured in degrees, including external rotation, internal rotation, abduction, and forward elevation. |
| Shoulder Pain and Disability Index (SPADI) | Baseline, 1 month, 3 months, and 6 months | Change in shoulder pain and disability assessed using the Shoulder Pain and Disability Index (SPADI), a validated 13-item questionnaire scored from 0 to 100, with higher scores indicating greater pain and disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Score | 6 months | Patient-reported satisfaction assessed using a numeric rating scale ranging from 0 to 10, where 0 indicates not satisfied at all and 10 indicates completely satisfied with the treatment. |
| Procedure-Related Complications | 1 month | Occurrence of immediate or delayed complications related to the procedures. |
| Rotator Cuff Interval Doppler Signal | Inclusion, 3 months ,6 months | Presence of Doppler signal at the rotator cuff interval assessed by shoulder ultrasound, reported as present or absent. |
| Coracohumeral Ligament Thickness | Baseline, 3 months, and 6 months | Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound. |
| Glenohumeral Capsular Thickness | Baseline, 3 months, and 6 months | Thickness of the glenohumeral joint capsule measured in millimeters using shoulder ultrasound at the axillary recess. |
Countries
Tunisia
Outcome results
None listed