Neurobiology of Pain in Burn Survivors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSpaulding Rehabilitation Hospital
About this trial
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 6-week, remotely delivered cognitive-behavioral therapy program reduces pain interference (disruption to daily life) and pain catastrophizing more effectively than an 6-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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralAn 6-week, remotely delivered behavioral intervention administered weekly via secure video conferencing by a trained psychologist (approximately 60 minutes per session). It utilizes active, structured techniques (such as relaxation, thought-stopping, distraction, and cognitive restructuring) along with in-vivo and home practice to target and reduce maladaptive pain-related cognitions (i.e., pain catastrophizing).
Pain Education
BehavioralAn 6-week, remotely delivered educational control intervention administered weekly via secure video conferencing by a trained psychologist (approximately 60 minutes per session). Matched for therapist contact time with the Cognitive Behavioral Therapy group, sessions cover standard pain-related topics (e.g., Gate-Control Theory, types of chronic pain, working with healthcare providers) without active skill-building components, handouts, or at-home practice.
Treatment groups
92 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group B: Pain EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
fMRI Measure
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.
Time frame
Baseline and 6 weeks (post-intervention).Secondary outcomes
1
Pain Catastrophizing Scale (PCS)
The Pain Catastrophizing Scale (PCS) will be used to evaluate negative cognitive-emotional responses to pain across three subscales: helplessness, magnification, and rumination. Scores range from 0 to 52, with higher scores indicating greater pain catastrophizing (worse outcome).
Time frame
Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).2
Brief Pain Inventory (BPI)
Measured using the Brief Pain Inventory (BPI) Pain Interference subscale. Evaluates how pain impacts daily activities, mood, mobility, work, relationships, sleep, and enjoyment of life on a scale of 0 to 10, where higher scores indicate greater pain interference (worse outcome).
Time frame
Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)Other outcomes
1
Patient-Reported Outcomes Measurement Information System (PROMIS-29)
Measured using the 29-item Patient Reported Outcomes Measurement Information System (PROMIS-29). Evaluates sub-scores for physical function, fatigue, sleep disturbance, social participation, depression, and anxiety.
Time frame
Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up).2
Quantitative Sensory Testing (QST) Battery
An in-person somatosensory assessment utilizing calf cuff pressure algometry to evaluate individual pain thresholds (mild, moderate, and high pain) as well as dynamic pain mechanisms, including temporal summation of pain and conditioned pain modulation.
Time frame
Baseline, and 6 weeks (post-intervention).3
Coping Strategies Questionnaire
Assesses cognitive and behavioral strategies used to cope with pain, including distraction, coping self-statements, and other pain management approaches. Higher scores indicate greater use of the specified coping strategy.
Time frame
Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)4
Pain Self-Efficacy Scale
Assesses an individual's confidence in their ability to perform daily activities, achieve goals, and manage the consequences of chronic pain. Higher scores indicate greater pain self-efficacy.
Time frame
Baseline, 6 weeks (post-intervention), and 24 weeks (follow-up)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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