A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articul… (NCT07680504) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Pilot Superiority Study Comparing the Efficacy of a Combination of a Glenohumeral Intra-articular Injection With a Suprascapular Nerve Block Versus a Glenohumeral Intra-articular Corticosteroid Injection in Retractile Capsulitis
France38 participantsStarted 2026-06-25
Plain-language summary
Drug Trial
* Single-center
* Exploratory trial
* Controlled
* Randomized
* Double-blind
* Prospective
Objective is to compare improvements in shoulder function at 3 months between the group receiving an intra-articular injection combined with a suprascapular nerve block and the group receiving an intra-articular injection combined with a placebo block 19 patients in the Experimental Group (block with corticosteroid and intra-articular injection on Day 0) 19 patients in the Control Group (block with saline and intra-articular injection on Day 0)
* Total duration: 36 months
* Recruitment period: 24 months
* Treatment duration per patient: 2 ultrasound-guided procedures on Day 0
* Follow-up duration per patient: 12 months after the procedure
At J0 : Under ultrasound guidance, inject 2 mL of lidocaine into the notch, then:
* Experimental Group: 8 mL of 1% lidocaine into the notch with 1 mL of betamethasone,
* Control Group: 9 mL of saline into the notch.
During these consultations, M1, M3, M6 et M12 , the following examinations will be performed:
* Clinical examination of the painful shoulder, including measurement of range of motion
* Visual Analog Scale (VAS) for pain
* Quick Dash, OSS, and SPADI self-report questionnaires completed by the patient
* Recording of complications
* Questions about returning to work
Who can participate
Age range
18 Years – 65 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:
* Patients with shoulder pain and stiffness that has persisted for at least 2 months but less than 12 months, with a loss of passive range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, forward flexion) of at least 30 degrees compared to the contralateral side
* Patients between the ages of 18 and 65
* Patients enrolled in a social security program
Exclusion Criteria:
* \- Corticosteroid injection into the affected shoulder \< 4 months ago
* History of any surgery on the affected shoulder within the past 12 months
* Patients with a neuromuscular condition (neurological deficit) or shoulder condition (arthropathy) that could interfere with the assessment of the primary endpoint
* Signs or risk of infection (bacterial-like infection and/or fever and/or antibiotic use)
* Poor skin condition of the affected shoulder
* Anticoagulation with VKAs or anti-Xa agents, or active bleeding disorder or one in remission for less than 5 years (malignant hematologic disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents permitted except prasugrel and clopidogrel)\*
* Uncontrolled hypertension,
* Decompensated diabetes or diabetes at risk of decompensation,
* Contraindications to diprosten, Kenacort, or lidocaine
* Psychiatric conditions that may be exacerbated by corticosteroids
* Pregnant or breastfeeding women, or women who refuse to use effective contraception
* Individuals belonging to a vulnerable…
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
Difference in Quick DASH scores between baseline and M3