An interventional study of capsular distension and Betamethasone (Diprostene®) Injection in Adhesive Capsulitis of the Shoulder, sponsored by Faculty of Medicine of Tunis. Not yet recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by Faculty of Medicine of Tunis · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Ultrasound-guided capsular distension with immediate mobilization followed by a standardized rehabilitation program.
Procedure: capsular distension
Ultrasound-guided intra-articular injection of betamethasone (Diprostene®) into the glenohumeral joint, performed under sterile conditions, followed by a standardized rehabilitation program.
Procedure: Betamethasone (Diprostene®) Injection
Ultrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
Ultrasound-guided intra-articular Betamethasone (Diprostene®) Injection of the glenohumeral joint performed under sterile conditions, followed by a standardized rehabilitation program.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 1 month, 3 months, and 6 months
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.
Time frame: 6 months
Procedure-Related Complications
Occurrence of immediate or delayed complications related to the procedures.
Time frame: 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.
Time frame: Inclusion, 3 months ,6 months
Coracohumeral Ligament Thickness
Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
Plan to share: No — 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.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Faculty of Medicine of Tunis