Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Arthritis Index (WOMAC)
研究概览
简要总结
Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. This study will compare these two options.
详细描述
Background: Cooled radiofrequency ablation (cRFA) of the knee geniculate nerves is a promising treatment option for knee osteoarthritis, but has variable efficacy. Fluoroscopy is the typical guidance of choice, but uses bony landmarks to target these nerves which have variable positions around the knee. Alternatively, ultrasound allows for targeting based on visualization of bony landmarks, the nerves, and their accompanying vascular structures, and thus may offer greater accuracy. However, there are few studies which directly compare the clinical efficacy of these two guidance options. Objective: To compare the effectiveness of geniculate nerve cRFA on knee osteoarthritis outcomes when using either ultrasound or fluoroscopic guidance. The primary outcome measures will be patient pain levels and patient-reported function. The secondary outcome measures will be objective performance-based functional outcomes. The exploratory outcome measures will be blood biomarkers of inflammation, extracellular matrix turnover, and cartilage degradation. Methods: Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) or ultrasound (N=45) cRFA treatment arms. Baseline assessments will include 1) Numeric Pain Rating Scale, Western Ontario and McMaster Universities Osteoarthritis Index, and PROMIS depression and pain interference measures; 2) the Osteoarthritis Research Society International recommended physical performance assessments including the 30-Second Chair Stand Test, Stair Climb Test, 40m Fast Paced Walk Test, Timed Up and Go Test, and Six Minute Walk Test; and 3) in a subset of patients (N=24), blood biomarkers including MMP-3, IL-1β, TNF-α, COMP, and CTX-II. These measures will be re-assessed at one month (pain and patient-reported function only, via phone contact), three months, and 6 months after the cRFA procedure. Study endpoints will be assessed using a mixed model repeated measures analysis of variance using an alpha level of 0.05. Statement of Relevance: Knee osteoarthritis patients are commonly treated by sports medicine providers, who are typically well-trained in the use of ultrasound. Should ultrasound be demonstrated as effective for cRFA, sports medicine providers would be well-positioned to use relatively low-cost and accessible imaging technology to significantly improve patient pain and function using cRFA.
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 (Investigator)
盲法说明
A random number table will be used for group allocation and the values recorded separately into opaque, sealed envelopes. This will be performed by a clinical coordinator who is not involved in study to ensure allocation concealment. Outcomes for the primary, secondary, and exploratory aims will be completed by research staff who are blinded to the subject treatment allocation. Data analyses will also be completed in a blinded fashion by the study statistical consultant.
入排标准
- 年龄范围
- 35 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) patients of either gender with primary knee OA of one or both knees fulfilling the diagnostic criteria for knee OA by the American College of Rheumatology,
- •2) Kellgren-Lawrence score of two to four,
- •3) reported NPRS pain intensity of at least four on most or all days of the past week
- •4) pain resistant to conventional treatments which may include but is not limited to medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory drugs, opioids), physical therapy, and intra-articular injections (e.g. corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the case of bilateral knee OA, the most symptomatic knee will be treated and studied.
排除标准
- •1) age <35 years,
- •2) non-English speaking patients,
- •3) body mass index greater than 40,
- •4) previous radiofrequency ablation procedure for the knee,
- •5) active systemic or local infections at the site of needle/cRFA probe placement,
- •6) previous knee joint replacement surgery,
- •7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic arthritis,
- •8) non-ambulatory patients,
- •9) patients who are unable to provide their own consent (e.g. dementia),
- •10) unstable medical or psychiatric illness,
- •11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or similar devices,
- •12) patients seeking care as a part of workman's compensation or have litigation pending
- •13) a negative response to diagnostic geniculate nerve lidocaine injections.
研究组 & 干预措施
Subjects with knee OA using fluoroscopy for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to fluoroscopic (N=45) cRFA treatment arm.
干预措施: cRFA (Procedure)
Subjects with knee OA using ultrasound for cRFA intervention
Knee osteoarthritis patients (Kellegren-Lawrence Scale 2-4) that have been refractory to conservative treatments and report at least 80% pain relief with diagnostic geniculate nerve blocks will be enrolled and randomized to ultrasound (N=45) cRFA treatment arm.
干预措施: cRFA (Procedure)
结局指标
主要结局
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
时间窗: Baseline up to 24 months
The objective is to measure the patient's reported functional status.The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a total WOMAC score, however there are other methods that have been used to combine scores
PROMIS - Pain Interference
时间窗: Baseline up to 24 months
The objective is to measure the consequences of pain on the subject's life with a minimally important difference range of 2.35 to 2.4
PROMIS - Depression
时间窗: Baseline up to 24 months
The objective is to measure items relevant to the subject's mood, views of self, and engagement. The test version 8b has good responsiveness with a minimally important difference range of 3-3.1 in adults with knee OA.
Numeric Pain Rating Scale
时间窗: Baseline up to 24 months
The objective is to rate patient's reported pain. The NPRS asks for a number between zero and ten that fits best to the subject's pain intensity, with zero as "no pain at all" and ten representing "the worst pain ever possible". It has a similar minimal clinically significant difference (20%) as the visual analog scale and can be administered via a phone interview.
次要结局
- Timed Up and Go Test48(The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.)
- 30-Second Chair Stand Test(The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.)
- Stair Climb Test(The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.)
- 40m Fast Paced Walk Test(The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.)
- Six Minute Walk Test(The subjects will perform the OARSI-recommended performance-based functional tests at the baseline, three month, and six month time periods.)