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临床试验/NCT01794988
NCT01794988Unknown不适用

Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study

University of Vermont1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Pain

研究概览

简要总结

The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •At least 12 months of muscular-skeletal, non-neuropathic pain

排除标准

  • •Malignancy causing or influencing chronic pain
  • •Radiation or chemotherapy, or metastatic cancer of any type
  • •Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
  • •Neurological disorders such as epilepsy or stroke, or other medical conditions
  • •Psychiatric disorders
  • •Opioid medication use for pain management
  • •Past year history of illicit drug use that can result in altered cognition
  • •Pregnancy
  • •Exceeding weight limit of the MRI scanner
  • •Incompatible implants due to MRI safety
  • •Awaiting pain related surgical procedure
  • •Involved in pain-related litigation

研究组 & 干预措施

Group Cognitive Behavioral Therapy

Experimental

Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.

干预措施: Group Cognitive Behavioral Therapy (Behavioral)

Pain Education

Active Comparator

Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.

干预措施: Pain Education (Behavioral)

Therapeutic Interactive Voice Response

Experimental

Four months of therapeutic interactive voice response (TIVR).

干预措施: Therapeutic Interactive Voice Response (Behavioral)

No TIVR

Active Comparator

Control - no intervention

干预措施: NO TIVR (Behavioral)

结局指标

主要结局

Pain

时间窗: Seven Months

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

Magdalena Naylor, MD, PhD

Magdalena R. Naylor, MD, PhD

University of Vermont

研究点 (1)

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