A Retrospective Single-center Cohort Study on Patients With Chronic Knee Pain Treated With Conventional Radiofrequency of the Genicular Nerves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline.
研究概览
简要总结
Management of chronic knee pain remains a challenge to the treating physician. A radiofrequency treatment of the genicular nerves is a not yet established but promising technique. This procedure is minimal invasive and has few adverse events. For these reasons it can be advantageous and fulfilling the unmet needs of these chronic knee pain patients warranting further research of its efficacy.
To investigate this efficacy, all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain, will be retrospectively analyzed in a single-center cohort.
详细描述
This project has as primary objective the evaluation of treatment success of a conventional radiofrequency treatment of the genicular nerves in patients diagnosed with chronic knee pain due to osteoarthritis of the knee or persistent post-surgical pain (PPSP) at six weeks post treatment. Secondary objectives are evaluation of treatment effect at a third time point at the end of the inclusion period, subgroup analysis of treatment success based on indication to treatment, evaluation of subjective functional improvement and change in analgesics, estimation of the duration of effect of the treatment and adverse events.
This study includes all patients treated with radiofrequency ablation in the multidisciplinary chronic pain center in Ziekenhuis Oost-Limburg, Campus Sint-Barbara between 1 September 2017 and 31 December 2019 with exclusion of patients with chronic widespread pain.
The main study outcome is the proportion of patients with a global perceived effect of at least 50% at 6 weeks post intervention. Secondary outcomes include reduction in pain intensity, measured by Numeric Rating Scale (NRS) at six weeks and at a third time point, global perceived effect at a third time point, subjective change in physical functioning, duration effect of the treatment, use of strong opioids, and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •All patients with chronic knee pain who qualify for a conventional RF treatment of the genicular nerves
排除标准
- •A negative diagnostic block with lidocaine 2% 1 ml of the three genicular nerves defined as less than 50% pain reduction
- •Chronic widespread pain
结局指标
主要结局
The Number of Patients Reaching Treatment Succes at 6 Weeks Defined as Global Perceived Effect (GPE) of ≥ 50% Compared to Baseline.
时间窗: 6 weeks after treatment
Treatment success is defined as a global perceived effect (GPE) of at least 50% at measurement time point compared to baseline. Global perceived effect (GPE) scales are used as an overall outcome measure for patients with pain, as they may cover additional aspects to pain relief and physical function that are important to the individual. Patients are asked to response on the question of how the treatment influenced the pain symptoms. The patients were asked to expres their answer in percentage where 0 % ( no improvement) to 100 (total improvement, the symptoms are gone).
次要结局
- The Number of Participants With NRS Reduction ≥50% Compared to Baseline(6 weeks after treatment)
- The Patient's NRS(after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure)
- The Number of Patients With Subjective Increase in Physical Functioning at the Second Time Point(after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure)
- The Number of Pariticipants Using Strong Opioids(6 weeks after treatment)
- Strong Opioid Use at the Second Time Point(after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure)
- The Number of Participants Reaching Treatment Success After Retrieval of the Informed Consent Defined as GPE of ≥ 50% Compared to Baseline.(after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure)
- Number of Participants With Post-treatment Complications(after retrieval of informed consent, ranging from 6 weeks to 2.5 years after the procedure)
研究者
Jan Van Zundert
Principal Investigator
Ziekenhuis Oost-Limburg