2026-525317-31-00招募中2 期
Pilot study comparing the efficacy of intra-articular glenohumeral injection combined with suprascapular nerve block versus intra-articular glenohumeral corticosteroid injection in adhesive capsulitis.
Centre Hospitalier Universitaire De Nantes2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2026年5月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- The primary endpoint is the difference in Quick DASH scores between enrollment and M3.
研究概览
简要总结
Compare the improvement in shoulder function at 3 months between the intra-articular injection group combined with a suprascapular nerve block and the intra-articular injection group combined with a placebo block.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall Trial
- 盲法
- Double (Investigator, Subject)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with shoulder stiffness lasting at least 2 months and less than 12 months, with a loss of passive joint range of motion in at least 2 planes (lateral rotation, medial rotation, abduction, antepulsion) of at least 30 degrees compared to the contralateral side
- •Patients aged between 18 and 65 years
- •Patients affiliated with a social security system
排除标准
- •Corticosteroid injection in the affected shoulder < 4 months
- •Anticoagulation with VKA or anti-Xa, or bleeding disorder currently active or in remission for less than 5 years (malignant blood disorders, myelodysplasia, autoimmune thrombocytopenia) or chemotherapy (antiplatelet agents authorized except prasugrel and clopidogrel)*
- •Uncontrolled high blood pressure,
- •Uncontrolled diabetes or at risk of decompensation,
- •Contraindications for diprosten, Kenacort, or lidocaine
- •Persons belonging to a vulnerable group as defined by Regulation (EU) No. 536/2014 and French law
- •Patients who are unable to comply with the protocol requirements
- •Psychiatric condition likely to be decompensated by corticosteroids
- •Women who are pregnant or breastfeeding or who refuse effective contraception
- •Patients participating in another clinical research protocol involving a drug or medical device
- •Patients refusing to participate in the study
- •History of any surgery on the affected shoulder within the last 12 months
- •Patients with neuromuscular disorders (neurological deficits) or shoulder disorders (arthropathy) that could interfere with the assessment of the primary endpoint
- •Signs or risks of infection (bacterial infection and/or fever and/or antibiotic use)
- •Poor skin condition of the pathological shoulder
研究组 & 干预措施
DIPROSTENE, suspension injectable en seringue pré-remplie
Test
干预措施: DIPROSTENE, suspension injectable en seringue pré-remplie (Drug)
SODIUM CHLORIDE
Placebo
干预措施: SODIUM CHLORIDE (Drug)
LIDOCAINE HYDROCHLORIDE
Test
干预措施: LIDOCAINE HYDROCHLORIDE (Drug)
结局指标
主要结局
The primary endpoint is the difference in Quick DASH scores between enrollment and M3.
The primary endpoint is the difference in Quick DASH scores between enrollment and M3.
次要结局
- Assessment of function using a Quick Dash score on D0, M1, M3, M6, and M12 and measurement of the area under the curve.
- Assessment of pain: VAS on D0, M1, M3, M6, and M12
- Measurement of joint range of motion with a goniometer on D0, M1, M3, M6, and M12.
- EVA pain before and after the procedure; collection of adverse events at Day 0, Month 1, Month 3, Month 6, and Month 12.
- Time to return to work after the procedure for patients who were employed at Day 0, 1 month, 3 months, 6 months, and 12 months.
研究者
Arnolfo
Scientific
Centre Hospitalier Universitaire De Nantes
研究点 (2)
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