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.
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
Rotator cuff tear
Previous shoulder surgery
Cervico-brachial neuralgia
Pregnancy or breastfeeding
Parallel
capsular distension
Procedure/SurgeryUltrasound-guided glenohumeral capsular distension followed by immediate mobilization then a standardized rehabilitation program.
Betamethasone (Diprostene®) Injection
Procedure/SurgeryUltrasound-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.
Shoulder range of motion
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)
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.
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.
Procedure-Related Complications
Occurrence of immediate or delayed complications related to the procedures.
Rotator Cuff Interval Doppler Signal
Presence of Doppler signal at the rotator cuff interval assessed by shoulder ultrasound, reported as present or absent.
Coracohumeral Ligament Thickness
Thickness of the coracohumeral ligament measured in millimeters using shoulder ultrasound.
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