A Prospective Pilot Study Comparing Standard and Novel Radiofrequency Ablation Protocols for Chronic Knee Pain in Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 主要终点
- Nature of adverse events
研究概览
简要总结
Brief Summary
The goal of this pilot study is to evaluate the feasibility and safety of conducting a randomized comparison of two standard-of-care knee radiofrequency ablation (RFA) techniques in adults with chronic knee pain related to knee osteoarthritis.
Participants who are already scheduled to receive knee RFA as part of their standard clinical care will be randomized to receive either a standard 3-target (standard) RFA protocol or a 6-target (novel) RFA protocol. The main purpose of this pilot study is to determine whether a future larger randomized trial comparing these two RFA approaches is feasible and safe to conduct.
Participants will complete questionnaires about pain, knee function, and stiffness at baseline and at follow-up timepoints for up to 12 months after the RFA procedure. Preliminary pain relief outcomes will also be explored to help inform the design of a future definitive trial.
Participants already scheduled for a knee RFA procedure as part of their standard of care for pain related to knee osteoarthritis will answer online survey questions about their pain for up to 12 months.
详细描述
This is a prospective, longitudinal, single-centre randomized pilot study with follow-up to 12 months. Participants scheduled to receive standard-of-care knee RFA for chronic knee pain related to osteoarthritis will be randomized through REDCap in a 1:1 manner to receive either the standard 3-target RFA protocol or the novel 6-target RFA protocol.
In usual clinical care, the RFA technique would typically be selected by the treating physician and both techniques are being done as standard of care. In this study, assignment to one of the two RFA techniques will be randomized. The RFA procedure itself will be completed as part of standard clinical care.
Study-related activities include randomization, collection of limited demographic and clinical information from the medical record, collection of procedural information, adverse event monitoring, and participant-reported outcome assessments. Outcomes will be collected at baseline before the procedure and at 3, 6, 9, and 12 months post-procedure. Follow-up may be discontinued at or after 6 months if the participant's pain returns to baseline levels or if the participant undergoes a repeat procedure.
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with knee osteoarthritis receiving knee RFA.
- •Stable pain medications for past 1 month.
- •Able to speak English.
排除标准
- •Scheduled for knee surgery within 6 months following RFA procedure.
- •Participating in another study that the Principal Investigator or Co-Investigators deem will interfere with the interpretation of the results.
研究组 & 干预措施
Novel RFA
Participants randomized to this arm will receive the 6-target knee RFA protocol as part of their standard clinical care.
干预措施: Radiofrequency ablation - 6-target technique (Procedure)
Traditional RFA
Participants randomized to this arm will receive the standard 3-target knee RFA protocol as part of their standard clinical care.
干预措施: Radiofrequency ablation - 3-target technique (Procedure)
结局指标
主要结局
Nature of adverse events
时间窗: up to 12 months
The types of adverse events occurring while participants are in the study will be reviewed.
Frequency of adverse events
时间窗: up to 12 months
defined by the number of adverse events a participant experiences while participating in the study
Recruitment rate
时间窗: During enrolment period
Average number of participants enrolled per month during the recruitment period.
Retention and Attrition Rates
时间窗: 3, 6, 9, and 12 months post-procedure
proportion of participants retained and the proportion lost to follow-up at each scheduled follow-up timepoint
Questionnaire Completion Rate
时间窗: Baseline, 3, 6, 9, and 12 months post-procedure
completion rates for the Patient Numeric Rating Scale (PNRS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires at each scheduled study timepoint.
Procedural efficiency
时间窗: Baseline
total procedure duration, measured from needle placement to final lesion completion. The 6-target protocol will be compared with the 3-target protocol to determine whether it adds no more than 20 minutes on average and remains within the 60-minute operating room threshold.
次要结局
- Average time to return to <50% pain relief(Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure)
- Average time to return to baseline pain level(baseline, 3 months, 6 months, 9 months and 12 months post procedure)
- Change in functional outcomes(Baseline, as well as 3-, 6-, 9-, and 12-months post-procedure on the following questionnaires.)
研究者
John Tran
Principal Investigator, PhD
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's