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 (EBLOUIR)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Retractile Capsulitis
• Intervention / Treatment: Drug: Diprostene; Drug: Saline (0.9% NaCl)

• Study Type: Interventional
• Enrollment (Estimated): 38
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Paul ARNOLFO Paul, PH; Phone Number: 02 44 76 81 79; Email: Paul.arnolfo@chu-nantes.fr

Study Locations

• France
  • Nantes, France
    • CHU de Nantes
    • Contact: Paul Arnolfo, PH; Phone Number: 02 44 76 81 79; Email: Paul.arnolfo@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Placebo Comparator: Saline Solution; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in Quick DASH scores between baseline and M3	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1. Functional Assessment	Function using the Quick Dash	D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment	Function using the SPADI scores	D0, Month 1, Month 3, Month 6, month 12
1. Functional Assessment	Function using the OSS	D0, Month 1, Month 3, Month 6, month 12
Measuring Joint Ranges of Motion with a Goniometer		Day 0, Month 1, Month 3, Month 6, and Month 12
Pain Assessment	With VAS (Visual Analog Scale) 0-10	D0, Month 1, Month 3, Month 6, month 12
EVA pain before and after each movement		Day 0, Month 1, Month 3, Month 6, and Month 12
Return-to-work timelines following the procedure for patients who are employed		Month 1, Month 3, Month 6, and Month 12

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 25, 2026
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): June 25, 2029

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 25, 2026
• First Posted (Actual): July 2, 2026

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: June 25, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: intra-articular injection; suprascapular nerve block
• Additional Relevant MeSH Terms: Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: RC25_0554; 2026-525317-31-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No