Deep Repetitive Transcranial Magnetic Stimulation for Peripheral Neuropathic Pain. A Randomized Double-blind Sham-controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Usual pain intensity over the past 24 hours
研究概览
简要总结
Peripheral neuropathic pain is a disabling chronic pain condition that is difficult to treat. Repetitive transcranial magnetic stimulation (rTMS) to the motor cortex is a treatment method with growing evidence in its ability to alleviate neuropathic pain. This also applies to new deep rTMS coils which permits stimulation of larger cortical areas and with deeper penetration. The aim of this study is to investigate the analgesic efficacy of 5 days of deep rTMS compared to sham stimulation. We will also assess effects of deep rTMS on sleep, psychological fatctors, everyday functioning, and executive functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Blinding is achieved by inserting a card into the rTMS stimulator which determines whether the patient receives active or sham stimulation, making both participant and investigator blind towards group allocation. Care providers are also blinded to treatment allocation. Main efficacy analyses will be performed blinded without identification of participants and group allocation.
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years of age
- •Peripheral neuropathic pain related to postherpetic neuralgia, peripheral nerve injury, limb amputation, polyneuropathy or radiculopathy, fulfilling the criteria for probable or definite neuropathic pain (Finnerup et al. 2016)
- •Usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the BPI at screening
- •Daily pain
- •Pain for at least 3 months
- •Stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to inclusion participation
- •Ability to follow throughout the whole duration of the study
排除标准
- •atients with phantom limb pain after limb amputation
- •Any clinically significant or unstable medical or psychiatric disorder
- •Subjects protected by law (guardianship or tutelage measure)
- •History of or current substance abuse (alcohol, drugs)
- •Pending litigation
- •Contraindication to rTMS (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. All women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception)
- •Pain conditions more severe than peripheral neuropathic pain
- •Inability to understand the protocol or to fill out the forms
- •Other ongoing research protocol or recent past protocol within one month before the inclusion
结局指标
主要结局
Usual pain intensity over the past 24 hours
时间窗: Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values (one week before treatment) and 1 week after the last stimulation. Measurement ends 3 weeks after last stimulation]
Measured every day in a diary at the same hour (end of the day) on an 11-point NRS (0 = no pain, 10 = worst pain intensity imaginable of the current pain condition)
次要结局
- Intensity of dynamic mechanical allodynia(Baseline, 1 week and 3 weeks after the end of each stimulation period)
- Pain intensity over the last 24 hours(Baseline, 1 week and 3 weeks after the end of each stimulation period)
- Patient Global Impression of Change(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Blinding(3 weeks after the end of each stimulation period)
- Usual pain intensity over the past 24 hours(Analgesic efficacy of active and sham treatment is measured as the change in pain intensity scores between baseline values and 3 weeks after the last stimulation)
- Pain unpleasantness during the last 24 hours(Baseline, 1 week and 3 weeks after the end of each stimulation period)
- Proportion of responders(Baseline,1 week and 3 weeks after the end of each stimulation period])
- Hospital Anxiety and Depression Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Intensity of static mechanical allodynia(Baseline, 1 week and 3 weeks after the end of each stimulation period)
- Percentage pain intensity reduction(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Pain Catastrophizing Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Insomnia Severity Index(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Patient-Specific Functional Scale(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Executive functioning using the CANTAB battery(Baseline,1 week and 3 weeks after the end of each stimulation period)
- Side-effects(Immediately after the first rTMS session for both stimulation periods and 1 week and 3 weeks after each stimulation period)
研究者
Nadine Farnes
Ph.D. student
Oslo University Hospital