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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diprostene, Saline (0.9% NaCl).
- Who it may be relevant to
- Registry conditions: Retractile Capsulitis. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Diprostene
Supracapsular nerve block: injection of 10 mL of 1% lidocaine (2 mL along the needle path and 8 mL around the nerve), followed by an injection of 1 mL of DIPROSTENE®. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg. - Drug Saline (0.9% NaCl)
Suprascapular nerve block: Inject 2 mL of 1% lidocaine along the needle path, followed by 9 mL of normal saline. Intra-articular injection: injection of 2 mL of 1% lidocaine along the needle path and 1 mL of KENACORT RETARD® 40 mg.
Primary outcome measures
- Difference in Quick DASH scores between baseline and M3 [Time frame: 3 months]
Secondary outcome measures (7)
- 1. Functional Assessment [Time frame: D0, Month 1, Month 3, Month 6, month 12]
- 1. Functional Assessment [Time frame: D0, Month 1, Month 3, Month 6, month 12]
- 1. Functional Assessment [Time frame: D0, Month 1, Month 3, Month 6, month 12]
- Measuring Joint Ranges of Motion with a Goniometer [Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12]
- Pain Assessment [Time frame: D0, Month 1, Month 3, Month 6, month 12]
- EVA pain before and after each movement [Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12]
- Return-to-work timelines following the procedure for patients who are employed [Time frame: Month 1, Month 3, Month 6, and Month 12]
Eligibility criteria
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 group as defined by Regulation (EU) No. 536/2014 and French law (See section 4.4 of the protocol) - - Patients unable to comply with the protocol requirements (see Section 4.4 of the protocol)
- Patients participating in another clinical research protocol involving a drug or medical device
- Patients who refuse to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- CHU de Nantes — Nantes
Identifiers
NCT: NCT07680504 · RC25_0554 · 2026-525317-31-00