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

Обзор

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

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Difference in Quick DASH scores between baseline and M3 [Срок оценки: 3 months]

Вторичные конечные точки (7)

• 1. Functional Assessment [Срок оценки: D0, Month 1, Month 3, Month 6, month 12]
• 1. Functional Assessment [Срок оценки: D0, Month 1, Month 3, Month 6, month 12]
• 1. Functional Assessment [Срок оценки: D0, Month 1, Month 3, Month 6, month 12]
• Measuring Joint Ranges of Motion with a Goniometer [Срок оценки: Day 0, Month 1, Month 3, Month 6, and Month 12]
• Pain Assessment [Срок оценки: D0, Month 1, Month 3, Month 6, month 12]
• EVA pain before and after each movement [Срок оценки: Day 0, Month 1, Month 3, Month 6, and Month 12]
• Return-to-work timelines following the procedure for patients who are employed [Срок оценки: Month 1, Month 3, Month 6, and Month 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• \- 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• CHU de Nantes — Nantes

Идентификаторы

NCT: NCT07680504 · RC25_0554 · 2026-525317-31-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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