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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Study 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

Eligibility

Primary outcome measure(s)

• Difference in Quick DASH scores between baseline and M3 — 3 months

Trial sites (1)

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