Efficacy of Suprascapular Nerve Block on the Tolerability and Effectiveness of Shoulder Hydrodistension in Patients With Adhesive Capsulitis: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Shoulder Pain - Numeric Rating Scale for Pain (NRS 0-10)
研究概览
简要总结
Adhesive capsulitis ("frozen shoulder") causes significant pain and loss of shoulder mobility. Shoulder hydrodistension is an established treatment that can improve movement and reduce symptoms, but the procedure itself may be painful and difficult for some patients to tolerate.
This randomized clinical trial will evaluate whether performing a suprascapular nerve block with local anesthetic immediately before hydrodistension can reduce pain during the procedure, improve patient comfort, and potentially enhance clinical outcomes.
Participants will be randomly assigned to one of two groups:
hydrodistension alone, or
suprascapular nerve block followed by hydrodistension.
Pain, shoulder mobility, functional ability, psychological measures, and quality of life will be assessed at baseline, 1 month, and 3 months after the procedure. The study aims to determine whether adding a suprascapular nerve block provides better tolerability and improved recovery for patients with adhesive capsulitis.
详细描述
1 Efficacy of suprascapular nerve block on the tolerability and efficacy of shoulder hydrodistension in patients with adhesive capsulitis: randomized clinical trial
- Principal Investigator Name: João Paulo Castro Contact: jpcastro@med.up.pt
Under the supervision of:
Professor José Paulo Andrade Full Professor at the Faculty of Medicine of the University of Porto Professor Iva Brito Senior Consultant in Rheumatology at the Local Health Unit of São João EPE and Invited Professor at the Faculty of Medicine of the University of Porto
Porto - January 2026
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
- None
盲法说明
This is an open-label study. No participants, care providers, or outcome assessors are masked, and no additional masking procedures are used.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older
- •Clinical diagnosis of adhesive capsulitis of the shoulder
- •Persistent pain and functional limitation despite initial conservative treatment
- •Ability to understand study procedures
- •Ability to provide written informed consent
排除标准
- •Known allergy or hypersensitivity to ropivacaine or methylprednisolone
- •Active infection (local or systemic)
- •Uncontrolled coagulopathy or ongoing therapeutic anticoagulation
- •Recent surgery of the affected shoulder
- •Neurological disease affecting the upper limb
- •Pregnancy
研究组 & 干预措施
Hydrodistension Alone
Participants assigned to this arm will undergo standard ultrasound-guided shoulder hydrodistension without any prior nerve block. The procedure consists of an anterior intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This intervention represents the current standard treatment for adhesive capsulitis.
干预措施: Shoulder Hydrodistention (Procedure)
Suprascapular Nerve Block Followed by Shoulder Hydrodistension
Participants in this arm will receive an ultrasound-guided suprascapular nerve block immediately before the hydrodistension procedure. The nerve block is performed at the suprascapular notch using 2 mL of ropivacaine. After the block, participants undergo standard anterior shoulder hydrodistension consisting of an intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This combined approach is intended to improve procedural tolerance and potentially enhance clinical outcomes in adhesive capsulitis.
干预措施: Shoulder Hydrodistention (Procedure)
Suprascapular Nerve Block Followed by Shoulder Hydrodistension
Participants in this arm will receive an ultrasound-guided suprascapular nerve block immediately before the hydrodistension procedure. The nerve block is performed at the suprascapular notch using 2 mL of ropivacaine. After the block, participants undergo standard anterior shoulder hydrodistension consisting of an intra-articular injection of 20 mL of normal saline, 4 mL of ropivacaine, and 40 mg of methylprednisolone. This combined approach is intended to improve procedural tolerance and potentially enhance clinical outcomes in adhesive capsulitis.
干预措施: suprascapular nerve block (Procedure)
结局指标
主要结局
Change in Shoulder Pain - Numeric Rating Scale for Pain (NRS 0-10)
时间窗: "From enrollment to the end of follow up at 3 years
Shoulder pain intensity at rest and/or with movement will be measured using the Numerical Rating
次要结局
未报告次要终点
研究者
João Rocha Neves
MD, MSc, MPH, PhD, MBA, FEBVS
Universidade do Porto