Innovations in Genicular Outcomes Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 31
- 主要终点
- Pain intensity and interference scores via NRS (Numeric Rating Scale)
研究概览
简要总结
The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs [NSAIDs]).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening
- •Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator
- •Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application
排除标准
- •Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol
- •Planning to have a surgery other than on the target knee
研究组 & 干预措施
All participants
Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.
干预措施: Treatment for Knee OA (Procedure)
结局指标
主要结局
Pain intensity and interference scores via NRS (Numeric Rating Scale)
时间窗: 18 months
NRS score from 0(being none)-10(being the worst)
Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form)
时间窗: 18 months
Pain intensity and interference scores via BPI-sf 0 to 10, where: 0 = no pain and 10 = pain as bad as you can imagine
Opioid use via pre-and post-treatment analgesic medication use log
时间窗: 18 months
Opioid use via pre-and post-treatment analgesic medication use log
Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement)
时间窗: 18 months
Functional status via KOOS-JR. 0(none)-4(extreme)
Functional status via SANE (Single Assessment Numeric Evaluation)
时间窗: 18 months
Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal)
Physical therapy utilization and work productivity via PT/Work Productivity
时间窗: 18 months
Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire.
Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)
时间窗: 18 months
Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)
Post-operative pain scores NRS (Numeric Rating Scale)
时间窗: 18 months
Post-operative pain scores (NRS) 0(being none)-10(being the worst)
Adverse events related to pain therapies
时间窗: 18 months
Adverse events related to pain therapies
General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)
时间窗: 18 months
General HRQOL via PROMIS-10. 1(Best)-5(Worst)
Patient Satisfaction
时间窗: 18 months
Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit.
Emergency Department (ED) visits
时间窗: 18 months
Emergency Department (ED) visits
Reimbursement status
时间窗: 18 months
Reimbursement status
Post-operative opioid consumption (analgesic medication use log)
时间窗: 18 months
Post-operative opioid consumption (analgesic medication use log)
Length of facility stay
时间窗: 18 months
Length of facility stay
次要结局
未报告次要终点