Neurobiology of Pain in Burn Survivors: Identification and Targeting of a Critical Treatment Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 主要终点
- fMRI Measure
研究概览
简要总结
Many burn survivors experience persistent, disabling pain that is strongly influenced by pain catastrophizing, a pattern of negative cognitive and emotional responses to pain involving feelings of helplessness, rumination, and magnification of symptoms. The primary purpose of this study is to evaluate whether an 8-week, remotely delivered cognitive-behavioral therapy program reduces pain interference (disruption to daily life) and pain catastrophizing more effectively than an 8-week pain education. Researchers also aim to identify the neurobiological mechanisms through which non-pharmacologic pain management works using functional Magnetic Resonance Imaging brain scans.
详细描述
Pain is particularly prevalent (>50%) and disabling following burn injuries. Chronic pain is strongly modulated by negative affect, and pain catastrophizing, a pain-specific psychosocial construct comprising helplessness, pessimism, rumination, and magnification about pain-related symptoms, is a critical predictor of pain severity and treatment satisfaction. Non-pharmacologic interventions such as Cognitive Behavioral Therapy (CBT) improve pain partially by reducing catastrophizing. However, the underlying neurobiology supporting catastrophizing in burn injury survivors remains understudied. Identifying objective, catastrophizing-linked neural biomarkers may serve as important therapeutic targets and predict clinical treatment response.
This study is a randomized, longitudinal neuroimaging trial evaluating the mechanisms of CBT compared to an active educational control. Participants with chronic burn pain are randomized in a 1:1 ratio to undergo one of two 8-week, remotely delivered interventions:
- CBT: Features 8 weekly 60-minute virtual sessions using active, structured cognitive-behavioral techniques. The intervention focuses on acquiring and practicing cognitive and emotional modulatory skills (e.g., relaxation, thought-stopping, distraction, cognitive restructuring) to reduce maladaptive pain-related cognitions.
- Pain Education (EDU): An active control condition matched for professional contact time, consisting of 8 weekly virtual sessions covering general pain-related topics (e.g., Gate-Control Theory, pain types) without active pain-coping skill acquisition or home practice.
Assessments and Imaging:
Assessments take place at baseline, 8 weeks (post-intervention), and 24 weeks (follow-up).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously hospitalized for burn injury
- •Age 18 to 65 years
- •Able to provide written informed consent and fluent in English
- •Living in a community setting
- •Six (6) months or more post-burn injury
- •Burn-related pain rated as ≥4 (on a scale of 0-10) over the past week, co-localized with the site of the burn injury
排除标准
- •Comorbid acute pain condition.
- •Comorbid chronic pain condition that is rated by the participant as more painful than the burn injury pain.
- •Living in an institution or medical facility.
- •Pregnant or nursing.
- •Any psychiatric condition precluding study participation, such as a disorder involving psychosis (e.g., schizophrenia), unmanaged bipolar disorder, or a severe personality disorder.
- •History of anxiety disorders or significant anxiety symptoms interfering with imaging procedures (e.g., panic).
- •Contraindication to MRI (e.g., implanted ferrous metal).
- •History of significant head injury (e.g., with substantial loss of consciousness).
- •Psychiatric hospitalization in the past 6 months.
- •Currently participating in therapeutic clinical research trials.
研究组 & 干预措施
Cognitive Behavioral Therapy
Participants receive an 8-week course of remotely delivered Cognitive Behavioral Therapy via secure video conferencing (1 weekly session, approximately 60 minutes each). The intervention focuses on a pain self-management paradigm, cognitive restructuring, and skill-building exercises (e.g., relaxation, thought-stopping, distraction) along with in-vivo and home practice to target and reduce maladaptive pain-related cognitions.
干预措施: Cognitive Behavioral Therapy (Behavioral)
Pain Education
Participants receive an 8-week course of remotely delivered Pain Education via secure video conferencing (1 weekly session, approximately 60 minutes each). Sessions cover general pain-related topics (e.g., Gate-Control Theory, acute vs. chronic pain, working with health care providers) without incorporating active coping skills training, handouts, or at-home practice.
干预措施: Pain Education (Behavioral)
结局指标
主要结局
fMRI Measure
时间窗: Baseline and 8 weeks (post-intervention).
Participants will undergo functional MRI scan sessions, including resting-state fMRI and task-based BOLD fMRI. Task-based fMRI utilizes a block-design contrasting 6 Pain Catastrophizing Scale statements (covering helplessness, magnification, and rumination) against 6 lexically matched neutral control statements.
次要结局
- Pain Catastrophizing Scale (PCS)(Baseline, 8 weeks (post-intervention), and 24 weeks (follow-up).)
- Brief Pain Inventory (BPI)(Baseline, 8 weeks (post-intervention), and 24 weeks (follow-up))
研究者
Jeffrey Schneider
Associate Professor, Harvard Medical School
Spaulding Rehabilitation Hospital