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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNantes University Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

- 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)

Trial design

Treatments tested in this trial

  • Diprostene
  • Saline (0.9% NaCl)

Treatment groups

38 Participants
are divided into 2 treatment groups

Sponsors and collaborators