Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis (NCT07409779) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Capsular Distension Versus Corticosteroid Injection in Adhesive Capsulitis
Tunisia50 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Shoulder Pain Intensity (Visual Analog Scale)
Timeframe: Baseline, 1 month, 3 months, and 6 months
2
Shoulder range of motion
Timeframe: Baseline, 1 month, 3 months, and 6 months
3
Shoulder Pain and Disability Index (SPADI)
Timeframe: Baseline, 1 month, 3 months, and 6 months