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临床试验/NCT07680504
NCT07680504尚未招募2 期

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

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年6月25日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
38
试验地点
1
主要终点
Difference in Quick DASH scores between baseline and M3

研究概览

简要总结

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • - 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

结局指标

主要结局

Difference in Quick DASH scores between baseline and M3

时间窗: 3 months

次要结局

  • 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)
  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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