NL-OMON56136招募中不适用
COMPARISON OF CONVENTIONAL AND COOLED RADIOFREQUENCY TREATMENT OF THE GENICULAR NERVES VERSUS SHAM PROCEDURE FOR PATIENTS WITH CHRONIC KNEE PAIN: A MULTICENTRE, DOUBLE BLIND, RANDOMISED CONTROLLED TRIAL - COGENIUS
Ziekenhuis Oost-Limburg0 个研究点目标入组 40 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
- 招募中
- 发起方
- 入组人数
- 40
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
- •* Signed written informed consent must be obtained before any study assessment
- •is performed.
- •* Adult patients (Age >= 18 years old).
- •* Chronic anterior knee pain (> 12 months) that is moderate to severe (defined
- •as NRS > 4 on most or all days for the index knee either constantly or with
- •* Unresponsive (meaning insufficient pain reduction or intolerance) to
- •conventional treatments ongoing for at least 12 months prior to inclusion.
- •Conventional treatments must include all of the following: active
- •physiotherapy, pharmacological treatment of pain and intra-articular
- •corticosteroid infiltration.
- •* Only for patients with OA: Radiologic confirmation of knee osteoarthritis of
- •grade 2 (mild), 3 (moderate) or 4 (severe) noted within 12 months prior to the
- •screening for the index knee according the Kellgren Lawrence criteria 54
- •diagnosed by an independent radiologist with experience in musculoskeletal
- •imaging on Rx or MRI.55 If imaging will need to be performed at screening it is
- •recommended to perform an MRI instead of Rx. Imaging with MRI will enable the
- •independent radiologist to perform a better estimation of the grade of OA.
- •* Only for patients with PPSP after TKA: Patients with PPSP after TKA need to
- •have had a negative orthopaedic work-up.
排除标准
- •* Local or systemic infection (bacteraemia) at the time of inclusion.
- •* 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.
- •* Pregnant, nursing or planning to become pregnant before the study
- •intervention. Participants who become pregnant after the study intervention
- •during the follow-up period will not be excluded.
- •* Chronic widespread pain.
- •* Patients with unstable psychosocial disorder.
- •Unstable psychosocial disorder is defined as:
- •o any untreated psychiatric conditions
- •o any psychiatric condition where the treating medication is not stable the
- •last 3 months prior to inclusion
- •o patients currently treated by a psychiatrist and the psychiatrist could not
- •confirm that the psychosocial disorder is stable.
- •Patients treated by a general practitioner are considered to have a stable
- •* Allergies to products used during the procedure (lidocaine, propofol,
- •chlorhexidine).
- •* 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 neurostimulator.
- •* Current radicular pain in index leg.
- •* Previous conventional or cooled radiofrequency of the index knee.
- •* Patients with bilateral knee pain defined as chronic knee pain (> 12 months)
- •in both knees that is moderate to severe (defined as NRS > 4 on most or all
- •days either constantly or with motion) and that is unresponsive (meaning
- •insufficient pain reduction or intolerance) to conventional treatments ongoing
- •for at least 12 months prior to inclusion. Conventional treatments must include
- •all of the following: active physiotherapy, pharmacological treatment of pain
- •and intra-articular corticosteroid infiltration.
- •* 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 who are unwilling or mentally incapable to complete the study
- •questionnaires.
研究者
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