Trans-spinal Magnetic Stimulation (TsMS) in Parkinson's Disease- Related Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Number of responders
研究概览
简要总结
Parkinson disease is the second most common neurodegenerative disease. Pain is the frequent non-motor symptom that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. There is currently no evidence-based treatment for PD-related pain in general. Nociceptive pain is the most frequent pain in PD an is frequently musculoskeletal in nature. Epidural spinal cord stimulation is known to provide analgesic effects in several types of pain syndromes. Here we test analgesic effects of a non-invasive trans-spinal magnetic stimulation as an add-on treatment for nociceptive (musculoskeletal) pain directly related to Parkinson disease.
详细描述
Background: pain is frequent non-motor symptom in Parkinson's disease (PD) that significantly compromises the quality of life, affecting 80% of patients during the course of the disease. Nociceptive pain is the most frequent subtype, mainly musculoskeletal in nature. There is currently no evidence-based treatment for PD-related pain in general. The present study tests the effectiveness and safety of non-invasive trans-spinal magnetic stimulation (TsMS) to treat musculoskeletal pain directly related to PD in a sham-controlled randomized approach.
Patients and Methods: this is a randomized, sham-controlled trial including 40 subjects, aged between 18 and 85 years, with musculoskeletal pain directly related to PD, that will be randomized to receive TsMS active or TsMS sham in a 1:1 ratio. Enrollment will take place at the Pain Center of the University of São Paulo and Movement Disorders Center of the University of São Paulo.
We have decided to perform an interim analysis when 24 patients will be included in the trial in order to assess safety and calculate effect size of the active intervention, after meeting with the research and statistical board. A decision will thereafter be made to, either: 1: halt the study due to futility, 2: continue the study with a new target sample size based on the calculations made with the effect from the n= 24 sample.
Expected results: the study hypothesis is that non-invasive trans-spinal magnetic stimulation is superior to sham and it is safe to use that device in patients with nociceptive (musculoskeletal) pain in PD.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease
- •Parkinsson disease related musculoskeletal Pain
- •Signed term of informed consent
排除标准
- •Pregnant or lacting women
- •Predominant neuropathic pain
- •The presence of psychiatric disorders such as uncontrolled posttraumatic stress disorder, uncontrolled depression, uncontrolled anxiety disorder and suicidal ideation;
- •Who wishes at any time to abandon the study;
结局指标
主要结局
Number of responders
时间窗: base line (moment of inclusion) and the last day of the patient assessment (2x in two months)
Number of individuals presenting 50% pain intensity reduction (on VNS 0-10 average pain of BPI item 5) in the active vs the sham group at the last (8th week) assessment compared to baseline values.
次要结局
- Incidence of Treatment-Emergent Adverse Events(Immediately after the intervention (session of stimulation))
- Parkinson's disease motor symptoms(base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months))
- Mood(base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months))
- Quality of life related to pain relief(base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months))
- Interference in daily activities(base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months))
- Global impression of change(base line (moment of inclusion) and the last day of the sessions of TMS-e (2x in two months))
- Change in baseline of Pain(base line (moment of inclusion) and in the last day after the final session of TMS-e (2x in two months))
研究者
Daniel Ciampi Araujo de Andrade, MD, PhD
MD, PhD (Head of Pain Division)
University of Sao Paulo