Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of participants at each Global Satisfaction Rating (GSR)
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-70 years of age, inclusive. 2 Neurological impairment secondary to SCI that occurred at least twelve (12) months prior to the Screening Visit; neurological level of injury between C6 and L5, inclusive.
- •Non-ambulatory, except for exercise or therapy purposes.
- •Uses a manual wheelchair. 5 History of chronic shoulder pain for ≥6 months that has been unresponsive to conservative treatment (e.g. physical therapy, pharmacological agents), and is rated as ≥4 out of 10 on an 11-point Numeric Rating Scale (NRS) (0 = "no pain"; 10 = "most intense pain imaginable") for average shoulder pain intensity during the week leading up to the Screening Visit.
- •Able and willing to comply with the protocol.
- •Able to give voluntary informed consent prior to the performance of any study-specific procedures.
排除标准
- •Contra-indications to the procedure (e.g. infection, coagulopathy)
- •History of active cancer within 5 years
- •Adhesive capsulitis
- •Prior history of regenerative medicine intervention
- •Glucocorticoid injection within the past four weeks
- •Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study
研究组 & 干预措施
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
干预措施: Lidocaine 1% Injectable Solution (Drug)
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
干预措施: Triamcinolone Injection (Drug)
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
干预措施: Suprascapular Nerve Block (Procedure)
结局指标
主要结局
Number of participants at each Global Satisfaction Rating (GSR)
时间窗: 1 month post procedure
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Number of participants reporting treatment related adverse events
时间窗: Up to 12 months
As per treating physician evaluation of participant adverse events related to the intervention
次要结局
- Number of participants at each Global Satisfaction Rating(Up to 12 months post procedure)
- Change in NRS scores(Baseline, 12 months)
- Change in DASH Questionnaire scores(Baseline, 12 months)
- Change in BPI-I scores(Baseline, 12 months)
研究者
Timothy Tiu
Assistant Professor
University of Miami