NCT02256371已完成不适用
Efficacy of 2 Psycho-physical Methods in the Treatment of Neuropathic Pain: a Randomized Controlled Monocentric Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Weekly mean pain intensity in patients diaries
研究概览
简要总结
A randomized double-blind controlled two centers study. The primary objective of this study will be to show a superiority of hypnosis over relaxation on pain intensity in patients with neuropathic pain.
详细描述
The secondary objectives of this study are:
- to show a superiority of hypnosis and relaxation over control group on neuropathic pain.
- to show a lasting effect of treatment on neuropathic pain one week after the end of treatment.
- to evaluate the clinical predictors of response to hypnosis (nature of neuropathic symptoms, severity of anxiety and depressive symptoms, pain catastrophizing, coping strategies, emotional regulation, response to the first session, positive or negative emotional reaction at the end of hypnosis sessions).
- to evaluate the effect of hypnosis at long-term (1, 3 and 6 months after the end of treatment).
- to evaluate the effect of hypnosis on emotional processes.
- to compare hypnosis to relaxation on short-term effects on pain,
- to evaluate the quality of life and the impact of pain on daily life: sleep, mood, anxiety symptoms, analgesics consumption , neuropathic symptoms, affective component of pain and pain catastrophizing.
35 patients will be enrolled in each arm, to obtain 105 in total (3 arms). Total duration for each patient: 8 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •peripheral or central neuropathic pain, probable or definite
- •Diagnostic questionnaire score DN4 ≥ 4/10
- •Chronic Pain with an average of pain intensity greater than or equal to 4/10 (digital scale)
- •Presence of daily or almost daily pain (i.e. at least 4 days per week)
- •Patient with pre-existing pain for > 6 months
- •Patient > 18 and < 60 years old
- •Patient with a stable analgesic treatment since 15 days before inclusion
- •Patient able to participate to the trial during 33 weeks
- •Patient having a health insurance
- •Written informed consent signed by the patient.
排除标准
- •Prior treatment with hypnosis
- •Currently under active psychotherapy (Cognitive-Behavior Therapy, psychoanalysis)
- •Work accident or litigation
- •Drugs abuse or Psychoactive Substance Abuse (DSM-IV)
- •Neuropathic pain associated with progressive disease (MS, HIV, cancer ...)
- •Major depression with ongoing disability or psychosis (DSM IV)
- •Intermittent pain
- •Patient with pre-existing pain for < 6 months
- •Other more severe pain than the pain justifying inclusion
- •Subject unable to understand the trial information provided in the informed consent document
- •Subject under curators or guardianship
- •Severe Handicap or amputation
- •Participation to another study in the same period
- •Cognitive disorders (dementia, Mild Cognitive Impairment, inability to understand the questionnaires)
- •For patients of the control arm: Treatment by hypnosis and / or relaxation, transcranial magnetic stimulation, or invasive treatments (surgery)
结局指标
主要结局
Weekly mean pain intensity in patients diaries
时间窗: 9 week
The pain intensity score will be recorded daily by each patient on a self-assessment diary using a scale of 0 to 10. The record will begin from the first session of hypnosis or relaxation to the last session (S1 to S9).
次要结局
- Evaluation of the feeling of comfort and relaxation(9 weeks)
- Interference with pain (Brief Pain Inventory)(8 months)
- Percentage of responders(8 months)
- Pain intensity measured at the end of each visit and 3 and 6 months after the end of the treatment(8 months)
- Affective components of pain(8 months)
- Emotional processes and Alexithymia(8 months)
- Neuropathic symptoms (NPSI)(8 months)
- Depression and anxiety(8 months)
- Pain catastrophizing(9 months)
- Pain relief(8 months)
- Quality of life assessment(8 months)
- Delay of onset of analgesic effects(8 weeks)
- Emotional distress caused by pain(8 months)
研究者
研究点 (2)
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