Complex Regional Pain Syndrome - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 4
- 主要终点
- 15-item quality of life measure
研究概览
简要总结
This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). The investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and MRI techniques.
详细描述
rTMS hypothetically disrupts the default networks related to chronic pain and renders the brain more susceptible to drugs, rehabilitation, or cognitive behavioral therapy. In addition, there is experimental evidence that rTMS releases factors that are involved in endogenous top-down modulation of pain and neural plasticity. Thus, the analgesic effect of rTMS may be mediated via enforcing endogenous pain control systems at the brain level, in addition to its effects on neuroplastic effects.
For active, navigated stimulation targets the investigators have the parietal opercular cortex overlying the secondary somatosensory cortex ("S2") and the primary motor cortex (M1).
The investigators randomize participants to first receive nrTMS to the right "S2" or sham stimulation. After ten sessions the investigators follow up the participants up to three months. At three months, if the average pain is ≥5/10 in numeric rating scale (NRS), the participant is offered an active, open nrTMS treatment phase depending on which treatment the participant first received. If the participant benefits from the open label treatment, a maintenance therapy is offered (6 months with gradually reducing nrTMS treatment frequency). The symptoms and quality of life are followed with questionnaires and diaries. After the maintenance period, the RN calls a structured interview at 1, 3, and 6 months.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The participant does not know whether the stimulation is sham or active. The doctor or nurse giving the stimulation knows the target and whether the stimulation is sham or active. The RN and the clinician (conducting screening and 1 month clinical visit) do not know the stimulation type or target until month 3, when the code is opened.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CRPS 1 or 2 of the upper limb
- •Duration ≥ 6 months
- •Mean pain (NRS) intensity ≥5/10
- •Medical and other therapies have failed
排除标准
- •Other stimulation therapies apart from transcutaneous nerve stimulation
- •psychotic disorder
- •severe depression
- •use of strong opioids
- •any contraindication for MRI
- •abuse of alcohol or drugs
- •ongoing insurance or other entitlement cases
结局指标
主要结局
15-item quality of life measure
时间窗: Change from baseline at one month
Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
次要结局
- Sleep interference and quality(Baseline and 1,2,and 3 months after intervention)
- Cognitive assessment B(Baseline and one month after the intervention)
- Weekly pain intensity and interference(Up to 3 months after intervention)
- Clinical neurophysiology measures(Baseline and one week after intervention)
- Hand strength(Baseline and one week after the intervention.)
- Brain imaging: Default mode networks(Baseline and one week after intervention)
- CRPS symptom severity(Baseline and at one month)
- Patient global impression of change(1, 2, and 3 months and through study completion, an average of 1 year)
- Mean pain intensity and interference(Baseline, during stimulation, and two weeks after the intervention)
- Cognitive assessment A(Baseline and one month after the intervention)
- Hand mobility(Baseline and one week after intervention)
- Cognitive assesment E(Baseline and one month after the intervention)
- Biochemical tests(At baseline)
- Cognitive assessment D(Baseline and one month after the intervention)
- DNA(At baseline)
- Screening of psychiatric symptoms and diagnostics(Up to 24 weeks)
- Cognitive assessment C(Baseline and one month after the intervention)
研究者
Hanna Harno
Principal Investigator
Helsinki University Central Hospital