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.
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →Faculty of Medicine of Tunis is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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