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
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
- 否
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
研究点 (1)
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