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

Phase 2Not Yet RecruitingNCT07680504

Nantes University Hospital38 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Retractile Capsulitis

Interventions

DiprosteneDRUG

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)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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Difference in Quick DASH scores between baseline and M3

Time frame: 3 months

Secondary Outcomes

1. Functional Assessment

Function using the Quick Dash

Time frame: D0, Month 1, Month 3, Month 6, month 12

1. Functional Assessment

Function using the SPADI scores

Time frame: D0, Month 1, Month 3, Month 6, month 12

1. Functional Assessment

Function using the OSS

Time frame: D0, Month 1, Month 3, Month 6, month 12

Measuring Joint Ranges of Motion with a Goniometer

Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12

Pain Assessment

With VAS (Visual Analog Scale) 0-10

Time frame: D0, Month 1, Month 3, Month 6, month 12

EVA pain before and after each movement

Time frame: Day 0, Month 1, Month 3, Month 6, and Month 12

Return-to-work timelines following the procedure for patients who are employed

Time frame: Month 1, Month 3, Month 6, and Month 12

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts