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

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

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

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