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临床试验/NCT03634670
NCT03634670已完成不适用

The Influence of Interdisciplinary Multimodal Pain Therapy on Cerebral Connectivity in Chronic Pain Patients

Technical University of Munich1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年1月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months

研究概览

简要总结

Due to its high prevalence and the substantial individual and socio-economic burden chronic pain is a huge challenge for patients, physicians and the society. Using neuroimaging structural and functional alterations have been described in the brain of patients suffering from chronic pain (Apkarian, Hashmi et al. 2011, Baliki and Apkarian 2015). However, reproducibility and functional significance of these changes are only incompletely understood. For example it remains unclear, if these changes covariate with clinical parameters and if they can be influenced or reversed by appropriate therapy. Some of the structural and functional brain changes in chronic pain patients have been shown to be reversible using magnetic resonance imaging after successful interventional pain treatment (Seminowicz, Wideman et al. 2011) or cognitive-behavioral therapy (Seminowicz, Shpaner et al. 2013, Shpaner, Kelly et al. 2014). Interdisciplinary multimodal pain therapy (IMPT) as a biopsychosocial treatment approach comprising physiotherapy and psychotherapy in structured programs has been shown to be effective in alleviating chronic pain of different entities including those where interventional therapy options are lacking or have been unsuccessful (Kaiser, Treede et al. 2017). The present study aims to investigate the influence of a structured IMPT approach provided in a day-clinic program of 20 treatment days on the functional brain network structure in chronic pain patients. To this end, a graph-theory based analysis (Bullmore and Sporns 2009) will be applied to electroencephalography (EEG) resting-state data from 30 chronic pain patients before and after IMPT and results will be correlated with behavioral and clinical data. In this observational study chronic pain patients that have been screened for participation in IMPT as part of routine medical care are invited to participate in a baseline visit prior to participation and a follow-up visit 6 months after completion of the program.

This will add to a better understanding of the complex functional brain alterations in chronic pain and might contribute to identify neuronal markers or even predictors for therapeutic responses in multimodal pain treatments. Moreover, the broad availability and easy applicability of EEG-measurements might enable a wide therapeutic application of potential findings in the near future.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic pain (duration >6 months, not primary headache disease)
  • Willing and able to comply with physical (e.g. able to get up from the floor without help) and psychological (e.g. motivation for behavioural change) requirements of the IMPT-day-clinic setting as assessed by a physician, psychologist and physiotherapist on a screening visit as part of routine medical care prior to participation
  • Willing and able to sign informed consent for study participation

排除标准

  • Recent change in chronic pain condition (e.g. surgery or injury within the last 3 months)
  • Concomitant neurological or psychiatric disease apart from Depression (especially severe mental disorder or psychopathology)
  • Regular (daily) intake of benzodiazepines
  • Addiction problems

结局指标

主要结局

Change from baseline visual analogue scale (VAS) ratings of pain intensity at 6 months

时间窗: Measured at baseline and at 6 months post treatment

Pain rating for average Pain intensity within the last 4 weeks on the VAS ranging from 0=no pain to 10=worst imaginable pain

次要结局

  • Change from baseline Pain related disability / Quality of life / Depression / Pain characteristics at 6 months(Measured at baseline and at 6 months post treatment)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (1)

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