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

NCT07680504 | Not Yet Recruiting Phase 2

• 2 other identifiers: RC25_05542026-525317-31-00
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Retractile Capsulitis

Keywords

suprascapular nerve block; intra-articular injection

Outcome Measures

Primary Outcomes (1)

• Difference in Quick DASH scores between baseline and M3

  3 months

Secondary Outcomes (7)

• 1. Functional Assessment

  D0, Month 1, Month 3, Month 6, month 12

• 1. Functional Assessment

  D0, Month 1, Month 3, Month 6, month 12

• 1. Functional Assessment

  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

  D0, Month 1, Month 3, Month 6, month 12

Study Arms (2)

Diprostene

EXPERIMENTAL

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

Saline Solution

PLACEBO COMPARATOR

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)

Interventions

Diprostene DRUG

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.

Diprostene

Saline (0.9% NaCl) DRUG

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.

Saline Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, France

Location

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Paul ARNOLFO Paul, PH

CONTACT

02 44 76 81 79; Paul.arnolfo@chu-nantes.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 2, 2026
• Study Start: June 25, 2026
• Primary Completion (Estimated): June 25, 2029
• Study Completion (Estimated): June 25, 2029
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)