NL-OMON55198已完成不适用
Comparison of cooled versus conventional radiofrequency treatment of the genicular nerves for chronic knee pain: a multicentre randomised controlled non-inferiority pilot trial - Cocogen trial
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age >= 18 years
- •- Able to understand the informed consent form and provide written informed
- •consent and able to complete outcome measures.
- •- Chronic anterior knee pain (> 12 months) with an NRS > 4 on most or all days
- •for the index knee either constantly or with motion.
- •- Unresponsive to conventional treatments continued during 12 months including
- •physiotherapy, oral analgesics or intra-articular infiltrations.
- •- Radiologic confirmation of arthritis of OA grade of 2 (mild), 3 (moderate)
- •or 4 (severe) noted within 6 months for the index knee according the Kellgren
- •Lawrence criteria (27) diagnosed by an independent radiologist with experience
- •in musculoskeletal imaging on Rx or MRI or patients with total knee
- •arthroplasty of the index knee with a negative orthopaedic workout.
- •- Other therapies (including surgical interventions) for pain in the index
- •knee are allowed for the period of the study follow up as long as they are
- •documented. This is necessary to correctly estimate the costs in the cost
- •effectiveness analyses. Allowing patients to receive additional treatments will
- •also improve the protocol compliance.
- •- Agree to provide informed consent and to comply with the requirements of
- •this protocol for the full duration of the study
排除标准
- •- Patient refusal to comply to protocol procedures or schedule
- •- Local or systemic infection (bacteraemia)
- •- Evidence of inflammatory arthritis or an inflammatory systemic disease
- •responsible for knee pain
- •- Intra-articular injections (steroids, hyaluronic acid, platelet enriched
- •plasma, *) in the index knee during the 3 months prior to procedure
- •- Body mass index (BMI) > 40 kg/m2
- •- Pregnant, nursing or planning to become pregnant
- •- Chronic widespread pain
- •- Patients with psychosocial dysfunction will be referred for further
- •psychological follow up prior to possible inclusion
- •- Allergies to products used during the procedure
- •- Uncontrolled coagulopathy defined as supratherapeutic dose of
- •anticoagulation medication.
- •- Uncontrolled immune suppression
- •- Participating in another clinical trial/investigation within 30 days prior
- •to signing informed consent
- •- Patient is currently implanted with a defibrillator, neuromodulator or other
- •electrical devices
- •- Radicular pain in index leg
- •- Patient received previous conventional or cooled radiofrequency of the index
研究者
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