Self-regulation of Real-time fMRI Brain Activity in Chronic Pain
ConditionFibromyalgia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
This study aims to explore the usefulness of self-regulation of brain activity in patients with fibromyalgia. Patients will use real-time functional magnetic resonance imaging (fMRI) neurofeedback to observe and regulate their own brain activity while applying mental strategies to reduce fibromyalgia pain. The study consists of 2 magnetic resonance imaging (MRI) visits that involve brain neuroimaging for fMRI neurofeedback tasks, as well as 8 weekly intervention sessions with a pain psychologist. Patients will be randomized to either Cognitive Behavioral Therapy (CBT) or Fibromyalgia Education groups.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-65
Meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
Disqualifiers
Comorbid acute pain condition
Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
Stimulant medications for the fatigue associated with sleep apnea or shift work (e.g., modafinil),
Pregnant or nursing
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Behavioral Therapy
BehavioralPracticing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
Disease Education
BehavioralProviding information about fibromyalgia, including its potential causes and management approaches.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Cognitive Behavioral TherapyExperimental treatment 1 intervention
Group B: Disease EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in brain activity in pain-associated regions such as vPCC/RSC
Changes in brain activity in pain-associated regions such as vPCC (ventral posterior cingulate cortex)/RSC (retrosplenial cortex), quantified as z-scores, during the self-regulation period of the MRI scan.
Time frame
Brain activity data will be collected at baseline and at post-treatment, spanning approximately 4 months.Secondary outcomes
1
Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed with the Pain Catastrophizing Scale (PCS). Pain Catastrophizing Scale (PCS) is a validated survey instrument that assesses the extent of catastrophizing thinking related to pain. Pain catastrophizing is assessed on a scale from 0 to 52, with higher scores indicating a higher levels of catastrophizing.
Time frame
PCS will be assessed at baseline and at post-treatment, spanning approximately 4 months.2
Brief Pain Inventory (BPI)
Brief Pain Inventory (BPI) is a validated questionnaire designed to assess the severity and interference of pain experienced. Pain severity is assessed on a scale from 0 (no pain) to 10 (severe pain). Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).
Time frame
BPI will be assessed at baseline and at post-treatment, spanning approximately 4 months.Other outcomes
1
Self-regulation performance
During each real-time fMRI self-regulation trial, patients will receive visual feedback of their modulated brain activity, and neurofeedback performance will be measured by their ability to successfully modulate the visual feedback indicator (i.e., increasing/decreasing it as instructed). Changes in performance scores between baseline and post-treatment will be calculated.
Time frame
Self-regulation performance will be assessed at baseline and at post-treatment, spanning approximately 4 months.2
Chronic Pain Self-Efficacy Score (CPSS)
Chronic Pain Self-Efficacy Score (CPSS) is a validated survey instrument that assesses an individual's beliefs and confident in their ability to manage and cope with chronic pain. Each item on the instrument is scored on a 10-point Likert Scale, from 10 (very uncertain) to 100 (very certain). Average subscale scores are calculated for each domain: self-efficacy for pain management (PSE), self-efficacy for coping with symptoms (CSE), and self-efficacy for physical function (FSE).
Time frame
CPSS will be assessed at baseline and at post-treatment, spanning approximately 4 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Brigham and Women's Hospital
Lead sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator
Spaulding Rehabilitation Hospital
Collaborator
Source ClinicalTrials.gov