Patients With Knee Pain Caused by Osteoarthritis: Comparison of Conservative Medical Management With RadioFrequency Ablation or Chemical Neurolysis of the Genicular Nerves With Phenol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Knee function measured with the Oxford Knee score (OKS)
研究概览
简要总结
A randomised controlled triall (RCT) with three parallel arms comparing the functional outcome of chemical ablation with phenol and radiofrequency ablation (RFA) of the genicular nerves with conservative treatment in patients with chronic knee pain caused by osteoarthritis (OA).
详细描述
In guidelines for knee osteoarthritis (OA), conservative treatments are physical therapy, analgesics and intra-articular injections with corticosteroids. In severe OA and persisting symptomatic cases the golden standard is joint replacing surgery. A less invasive technique is ablation of the sensory (genicular) nerves of the knee. This technique is beneficial for younger patients as a bridge to surgery or patients that cannot undergo total knee arthroplasty (TKA) due to comorbid health conditions. Nerve ablation can either be done with chemical agents or thermal energy.
Although there are numerous studies on genicular nerve block for chronic knee pain caused by OA, there are just a few small studies that compare genicular nerve block with conservative treatment.To be able to determine if genicular nerve ablation is efficacious to serve the gap between conservative treatment and TKA, this randomised controlled trial (RCT) compares two forms of genicular nerve ablation (radiofrequency and phenolisation; intervention) with conservative treatment (control) up to 6 months after treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients of both sexes, >35 years who are not a candidate for TKA due to young age, old age, comorbidity or technical reasons.
- •OKS < 30 on a scale from 0 (severe function) to 48 points (satisfactory function).
- •Continued pain in the target knee that is moderate to severe (defined as NRS ≥ 6 on an 11-point NRS scale) either constantly or with motion despite at least 3 months of conservative treatments. Conservative treatment can include: active physiotherapy, pharmacological treatment of pain (acetaminophen or NSAIDs) and intra-articular corticosteroid infiltration.
- •Radiologic confirmation of arthritis for the target knee. Defined as the Kellgren Lawrence (KL) score of 2 or more on X-ray or MRI.
排除标准
- •Patient with prior ablation of the genicular nerves, prior partial, resurfacing, or TKA of the target knee (residual hardware).
- •Patient with a history of neurovascular injury or recent trauma of the lower extremities.
- •Patient with chronic widespread pain.
- •Polyneuropathy and/or radicular pain in the lower extremities.
- •Patient is currently implanted with a neurostimulator.
- •Local or systemic infection (bacteraemia).
- •Uncontrolled immune suppression.
- •Intra-articular injections (steroids, hyaluronic acid, platelet enriched plasma, stem cell, ...) in the target knee within 90 days from randomisation.
- •Arthroscopic debridement/lavage into the target knee within 180 days from randomisation.
- •BMI<18,5 kg/m2 and patients with minimal subcutaneous tissue thickness that would not accommodate ablation with phenol or radio frequency (risk of skin burns).
- •Allergies to products used during the procedure (lidocaine, phenol, contrast dye).
- •Patients who have a planned TKA in the near future, defined as patients who already have agreed on a date for the TKA procedure.
- •Patients with psychosocial problems as determined by the investigator.
研究组 & 干预措施
Chemical ablation of the genicular nerves with Phenol 6%
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
干预措施: Genicular nerve block with Phenol 6% (Procedure)
Radiofrequency ablation (RFA) of the genicular nerves
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
干预措施: Diagnostic genicular nerve block (Procedure)
Radiofrequency ablation (RFA) of the genicular nerves
In our study we will make two RFA lesions at every target with 80°C for 90 seconds with a 5mm active tip. So we will make 6 lesions in total. The targets are the superomedial, the superolateral and the inferomedial genicular nerve.
干预措施: Genicular nerve block with Radiofrequency Ablation (RFA) (Procedure)
Conservative treatment
Examples of allowed conservative treatments during the study are patient education, physical therapy, weight loss and different pharmacological treatments.
Chemical ablation of the genicular nerves with Phenol 6%
Chemical ablation with phenol is done by injection of 1,5ml of phenol 6 % at the superomedial, the superolateral and the inferomedial genicular nerve.
干预措施: Diagnostic genicular nerve block (Procedure)
结局指标
主要结局
Knee function measured with the Oxford Knee score (OKS)
时间窗: During intake, before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).
Questionnaire with 12 items. Scores can range from 0 to 48, with 48 being the best outcome and a lower score indicates more functional limitations and pain.
次要结局
- Medication changes(Before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.)
- Pain measured with the Numeric Rating Score (NRS)(In rest during intake and in rest and during performance based tests before and after the diagnostic nerve block (if applicable), before the intervention (if applicable), 6 weeks, 3 months, 6 months and 1 year after the intervention)
- Hospital Anxiety and Depression Scale (HADS)(At T=0 (before intervention) and during T=3 (6 months after intervention))
- Osteoartritis (OA) measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC)(Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).)
- Pain Catastrophizing Score (PCS)(At T=0 (before intervention) and during T=3 (6 months after intervention))
- Diagnostic block most appropriate cut-off value(Before and after the diagnostic block and during T=2 (3 months after intervention).)
- Patient Global Impression of Change (PGIC)(During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).)
- Minimal Clinically Important Difference (MCID) of the WOMAC(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.)
- 30 seconds chair-stand test(Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.)
- Patient satisfaction(During the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).)
- Minimal Clinically Important Difference (MCID) for the EQ-5D-5L(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.)
- Adverse events(After the diagnostic block, after the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up.)
- Health related quality of life with the EQ-5D-5L(Before the intervention or study start in conservative group (T=0) and during the follow up visits (T=1 at 6weeks, T=2 at 3 months, T=3 at 6 months and T=4 at 12 months after the intervention or study start).)
- Number of Total Knee Artroplasty's (TKA's)(At 6 weeks, 3 months, 6 months and 12 months follow up.)
- 40 meters (4x10m) fast-paced walk test(Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.)
- 9-steps stair-climb test(Before and after the diagnostic block, before the intervention (T=0), and at 6 weeks, 3 months, 6 months and 12 months follow up. In the conservative treatment group this will only be done at the applicable follow up dates.)
- Minimal Clinically Important Difference (MCID) of the OKS(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up. .)
- Minimal Clinically Important Difference (MCID) of the 9-steps stair-climb test.(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.)
- Procedure time(During the intervention visit (T=0))
- Minimal Clinically Important Difference (MCID) of the 30 seconds chair-stand test(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.)
- Minimal Clinically Important Difference (MCID) of the 40 meters (4x10m) fast-paced walk test(MCIDs will be determined for our population on T=1 (6weeks), T=2 (3 months) and T=3 (6 months) follow up.)