- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00796536
Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain
연구 개요
상세 설명
Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry.
To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain.
Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Vermont
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Burlington, Vermont, 미국, 05401
- MindBody Medicine Clinic
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back
- Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire
- Has ongoing standard pain management from a physician
- Agrees to participate in this research study
Exclusion Criteria:
- Malignancy
- Reflex sympathetic dystrophy and/or naturopathic pain
- Opioid medication use
- Substance use disorder
- Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study
- Major depression or/and dysthymia
- Post traumatic stress disorder or panic disorder
- Left-handedness
- Pregnancy
- History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition
- Exceeding the weight limit on the MRI scanner
- Suffering from claustrophobia
- Any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, intrauterine devices, shrapnel injuries
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 1
Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
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Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain.
These skills will include breathing exercises, distraction, and relaxation techniques.
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활성 비교기: 2
Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan.
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Patients will receive mailed educational materials to their homes on a weekly basis.
Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back.
Pain education is the standard of care for most outpatient clinics.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
기간: Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Acute pain perception and brain activation correlated with improvement in clinical outcomes
기간: Measured before and after the 12-week intervention
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Measured before and after the 12-week intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Magdalena R. Naylor, MD, PhD, MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .