Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsular Distension | Experimental | Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program. |
|
| Betamethasone (Diprostene®) injection | Experimental | Ultrasound-guided intra-articular injection of betamethasone (Diprostene®) into the glenohumeral joint, performed under sterile conditions, followed by a standardized rehabilitation program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsular distension | Procedure | Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder Pain Intensity (Visual Analog Scale) | 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. | Baseline, 1 month, 3 months, and 6 months |
| Shoulder range of motion | Change in active shoulder range of motion measured in degrees, including external rotation, internal rotation, abduction, and forward elevation. | Baseline, 1 month, 3 months, and 6 months |
| Shoulder Pain and Disability Index (SPADI) | 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. | Baseline, 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Score | 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. | 6 months |
| Procedure-Related Complications |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medecine of Tunis | Tunis | Tunis Governorate | Tunisia |
The IPD collected in this study will not be shared publicly. Data will be used exclusively by the study investigators for the purposes of this research.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D007267 | Injections |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Betamethasone (Diprostene®) Injection | Procedure | Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program. |
|
Occurrence of immediate or delayed complications related to the procedures. |
| 1 month |
| Rotator Cuff Interval Doppler Signal | Presence of Doppler signal at the rotator cuff interval assessed by shoulder ultrasound, reported as present or absent. | Inclusion, 3 months ,6 months |
| Coracohumeral Ligament Thickness | Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound. | Baseline, 3 months, and 6 months |
| Glenohumeral Capsular Thickness | Thickness of the glenohumeral joint capsule measured in millimeters using shoulder ultrasound at the axillary recess. | Baseline, 3 months, and 6 months |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |