The Effectiveness of Shoulder Terminal Sensory Articular Nerve Radiofrequency Ablation for Non-surgical Refractory Shoulder Pain Due to Rotator Cuff Pathology and Osteoarthritis; A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
研究概览
简要总结
Through this prospective, single-arm cohort pilot study, we plan to explore the safety and effectiveness of Shoulder Radiofrequency Ablation (SRFA) in patients with non-operative chronic shoulder pain due to shoulder osteoarthritis with or without rotator cuff tears.
详细描述
This will be one of the first collaborative prospective, single-arm cohort using a standardized selection protocol and comprehensive SRFA protocol to treat chronic, refractory shoulder pain due radiographically confirmed glenohumeral joint OA with or without RTC pain, in patients deemed non-surgical candidates by a board-certified orthopedic shoulder surgeon. Upon completing the proposed research, we expect our contribution to fill the knowledge gap on whether SRFA is a potentially viable treatment option for this patient population. This contribution is expected to be substantial because SRFA may be a safe and effective treatment option for many people suffering shoulder pain and debility who are sub-optimal surgical candidates and have historically either been undertreated to have less than ideal treatments options, including opioid-based pain management in particular.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥50 years old capable of understanding and providing consent in English, and capable of complying with the outcome instruments used
- •≥3 months of shoulder pain refractory to conventional treatment (i.e., physiotherapy, medication, steroid injections)
- •Persistent shoulder pain ≥ 4/10 in intensity on a 7-day average
- •Shoulder pain refractory to conventional treatment (i.e., physical therapy, oral analgesics, steroid injection)
- •Prior consultation with a board-certified orthopedic shoulder surgeon, deemed a non-surgical candidate for the primary diagnosis of glenohumeral joint pain +/- rotator cuff pain
- •≥80% pain relief for at least 30 minutes after a single fluoroscopically-guided block of the sensory branches of the SN, AN, and LPN with 0.5 mL of lidocaine at each nerve
- •Scheduled for procedure of interest
排除标准
- •Allergy to any medication needed to participate in this study
- •Previous partial/total/reverse shoulder arthroplasty. Participants with a history of RTC repair will not be excluded.
- •Neurologic disorders including radiculopathy, connective tissue/inflammatory joint disease/widespread soft tissue pain disorder
- •Severe, uncontrolled psychiatric disorder requiring hospitalization within 6 months
- •Intraarticular or subacromial injection to the study shoulder within 3 months before C-SRFA
- •Uncontrolled bleeding diathesis
- •Pacemaker, neurostimulator, or other implanted device potentially sensitive to RF energy
- •Active Worker's compensation claim, litigation, or other possible reason for secondary gain.
- •Prior shoulder radiofrequency ablation
- •Daily opioid use
结局指标
主要结局
Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA
时间窗: 1, 3, 6 and 12 months
Pain reduction will be measured by calculating the proportion of participants who experienced ≥50% reduction of their shoulder pain on the Numerical Rating Scale (NRS) at 1, 3, 6 and 12 months after the SRFA.
次要结局
- Patient Global Impression of Change (PGIC) at 1,3, 6 and 12 months after SRFA(1, 3, 6 and 12 months after SRFA)
- American Shoulder and Elbow Surgeons Score (ASES) at 1,3, 6 and 12 months after SRFA(1, 3, 6 and 12 months after SRFA)
- Myotomal strength at 1, 3, 6 and 12 months after SRFA(1, 3, 6 and 12 months after SRFA)
研究者
Allison Glinka Przybysz
Assistant Professor
University of Utah