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临床试验/NCT04603417
NCT04603417已完成不适用

Pain Avoidance Behavior and Its Relation to Risk for Opioid Use in Chronic Pain Patients

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2020年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Temperament and Character Inventory

研究概览

简要总结

This study is designed to find behavioral and neurophysiological correlates of pain avoidance behavior among chronic pain patients, controlling for risk for opioid use disorder. Further, traits and risk factors that contribute to pain avoidance behavior will be investigated. The knowledge gained will broaden the current understanding of mechanisms involved in pain avoidance behavior in chronic pain patients, and help devise novel interventions.

详细描述

Overall Research Design. The overarching goal of this study is to gain mechanistic insights into maladaptive pain avoidance behavior and risk factors that could provide a pathway for OUD in chronic pain patients. We aim to explore the neurophysiological constructs (brain oscillations) of the maladaptive pain avoidance behavior. Advancing this knowledge will open new opportunities for future clinical interventions to prevent opioid addiction in chronic pain patients. Aim-1 is based on a mechanistic framework termed predictive coding, and is designed to elicit cue-pain associative learning impairments that form the basis for maladaptive pain avoidance behavior in chronic pain patients. Aim-2 is designed to examine the influence of OUD related personality traits and risk factors in moderating maladaptive pain avoidance behavior. We strongly believe that aim-1 and 2 will aid the development of future clinical paradigms for early identification of patients vulnerable to OUD, treatment resistance and other psychodynamic factors that increase the risk for poor outcomes. Aim-3 further enhances the scope of the project by incorporating the study of brain oscillations during pain avoidance behavior that could help the development of non-addictive neuromodulation based interventions to promote extinction of learned maladaptive pain avoidance behavior.

Subjects. The study will evaluate patients with Complex Regional Pain Syndrome (CRPS) who present with central sensitization i.e. allodynia (pain response to a non-painful stimulus) and/or hyperalgesia (exaggerated pain response to a nociceptive stimulus), and age/gender matched healthy controls. The advantage of the CRPS model of chronic pain is that it is common and a common cause of post-injury disability. Additionally, patients typically present with an affected and non-affected extremity/site facilitating within-subject comparison. Patients will be considered candidates after review of their history, neurological and psychological pain assessment. Healthy controls will be recruited through fliers posted throughout our campus and by referrals from other studies.

Sample Size. Sample size is 30 patients and 30 age/gender-matched controls. The sample size was chosen based on the recommended power size for cue-based pain modulation studies.

Study Design. This cross-sectional study will present the participants with an instrumental pain avoidance learning task, while we record continuous MEG brain signals, and other autonomic measurements. All participants, upon initial screening and enrollment, will report to our MEG facility on the day of testing. They will undergo: 1) training to understand the task; 2) scalp measurements for head tracking inside the MEG scanner; and 3) actual testing in the MEG. A T1-weighted MRI (for anatomical co-registration of MEG data) will be acquired separately, if a suitable dataset is not already available.

Health History and clinical assessments. All patients will complete neuropsychological and pain assessments to rate their current pain, disability, fear, anxiety, and depression using standardized scales. In addition, we will administer Temperament and Character Inventory (TCI) questionnaire to assess the traits for aim-2.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • 18 years and older
  • Diagnosis of CRPS I, CRPS II
  • Six months or more of medically refractory severe pain
  • Average daily pain for the past 30 days reported as ≥ 5 on a 0 - 10 scale
  • Presence of allodynia
  • Unilateral pain or pain affecting predominantly one extremity. Predominantly will be operationally defined at >=75 of pain on one extremity.
  • Willingness to complete behavioral, clinical and neurophysiological measurement procedures
  • Able to provide informed consent
  • Able to undergo structural brain MRI

排除标准

  • 17 years and younger
  • All other pain diagnosis
  • Less than six months or more of medically refractory severe pain
  • Average daily pain for the past 30 days reported as < 5 on a 0 - 10 scale
  • Absence of allodynia
  • Bilateral pain
  • Unwillingness to complete behavioral, clinical and neurophysiological measurement procedures
  • Unable to provide informed consent
  • Claustrophobic or unable to undergo MRI, MEG or unsafe to undergo MRI (i.e. due to MRI unsafe medical implants).

结局指标

主要结局

Temperament and Character Inventory

时间窗: year1-5

Traits related to pain avoidance behavior

Magnetoencephalography (MEG)/Electroencephalography (EEG)

时间窗: year1-5

Brain oscillations during pain avoidance behavior

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raghavan Gopalakrishnan

Staff Scientist

The Cleveland Clinic

研究点 (2)

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