Pulsed Radiofrequency Therapy for Hand OsteoArthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham
研究概览
简要总结
Different types of pain may be present in patients with hand osteoarthritis, including nociceptive pain and non-nociceptive pain. This makes adequate pain treatment difficult, and thus new treatment options are needed. To this end, this trial will evaluate the effect of transcutaneous pulsed radiofrequency for the treatment of hand osteoarthritis pain.
详细描述
In this randomized clinical trial, patients with hand osteoarthritis, recruited from the Leiden University Medical Center Rheumatology outpatient clinic, aged 18-80 and fulfilling hand pain criteria will be randomized to undergo trancutaneous pulsed radiofrequency therapy of the hand or a sham. The effect will be measured in change in 10 point numeric rating scale for pain in the hand over 6 weeks. This RCT will have little burdens and risk for the subjects. The proposed intervention, tPRF, is well tolerated, with no known serious side effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •Hand osteoarthritis according to the ACR criteria
- •Hand pain of at least 30mm on a 100mm VAS
- •Chronic hand pain
排除标准
- •Known inflammatory rheumatic diseases
- •Psoriasis
- •Seropositivity for rheumatoid factor of anti-CCP antibodies
- •No understanding of the Dutch language
- •Fibromyalgia (Following the ACR 2011 classification criteria)
- •Neurological disorders interfering with pain perception and measurements
- •Carpal tunnel syndrome interfering with pain perception and measurements
- •History of chemo- and/or radiotherapy
- •Spinal surgery or spinal trauma with lasting complaints interfering with pain perception and measurements
- •Cognitive impairment or psychiatric conditions interfering with pain perception and measurements
- •Pregnancy or breast-feeding
- •Eye surgery for glaucoma or keratoconus or other surgery of the cornea in the three preceding months
- •Presence of an implantable cardioverter-defibrillator (ICD), neurostimulator or pacemaker
- •Metal implants in the hand, arm, shoulder or neck of the side that is to be treated
结局指标
主要结局
Hand pain at 6 weeks after trancutaneous pulsed radiofrequency or sham
时间窗: 6 weeks
Hand pain measured in a 0-10 numeric rating scale after trancutaneous pulsed radiofrequency or sham
次要结局
- Hand pain at 12 weeks after trancutaneous pulsed radiofrequency or sham(12 weeks)
- Efficacy of transcutaneous pulsed radiofrequency on hand function(6 weeks, 12 weeks)
- Efficacy of transcutaneous pulsed radiofrequency on hand stiffness(6 weeks, 12 weeks)
- Global perceived effect of recovery due to trancutaneous pulsed radiofrequency(6 weeks, 12 weeks)
- Efficacy of transcutaneous pulsed radiofrequency on the number of tender joints(6 weeks, 12 weeks)
- Efficacy of trancutaneous pulsed radiofrequency on anxiety(6 weeks, 12 weeks)
- Efficacy of trancutaneous pulsed radiofrequency on depression(6 weeks, 12 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on health related quality of life(6 weeks, 12 weeks)
- Global perceived effect of satisfaction with trancutaneous pulsed radiofrequency(6 weeks, 12 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on temporal summation assessed using a 256 mN PinPrick(6 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on numbness of the hand.(6 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on allodynia(6 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on Michigan Hand Outcome Questionnaire(6 weeks, 12 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on central sensitization index scores(6 weeks, 12 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on PainDETECT scores(6 weeks, 12 weeks)
- Effect of transcutaneous pulsed radiofrequency therapy on AUSCAN pain scores(6 weeks, 12 weeks)
研究者
Margreet Kloppenburg, MD PhD
Professor
Leiden University Medical Center