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
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
- 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)
Parallel
Diprostene
DrugSupracapsular 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.
Saline (0.9% NaCl)
DrugSuprascapular 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.
Difference in Quick DASH scores between baseline and M3
1. Functional Assessment
Function using the Quick Dash
1. Functional Assessment
Function using the SPADI scores
1. Functional Assessment
Function using the OSS
Measuring Joint Ranges of Motion with a Goniometer
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
