Fibromyalgia
Conditions
Brief summary
This study design has two components: 1) a cross sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition. The investigators will evaluate a group of fibromyalgia patients who will receive CBT treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from pain-free controls and a group of education program controls. Participants will undergo experimental pain assessments as well as brain neuroimaging.
Detailed description
Investigators propose to use fMRI (functional Magnetic Resonance Imaging) to study CNS pain processing during the anticipation and experience of acute pain in individuals with FM and healthy controls. Investigators will recruit patients who are diagnosed with FM as well as healthy controls. After the baseline visit, FM participants will be randomly assigned into the CBT or control condition (Education). Overall, FM Participants will attend 8 treatment visits, and 6 assessment visits (two at baseline, one at mid-treatment, two at the end of treatment, and one at 6 months post-treatment). These assessment visits include a total of 3 fMRI sessions (at baseline, mid-treatment, and end of treatment). Healthy Controls will undergo the same baseline procedures as the FM subjects but will not attend any of the treatment or follow up assessment visits. Findings from this research will provide important information about catastrophizing's CNS (Central Nervous System) correlates.
Interventions
BEHAVIORALCognitive Behavioral Therapy
Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
BEHAVIORALDisease Education
Providing information about fibromyalgia, including its potential causes and management approaches.
Sponsors
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Study personnel collecting, entering, and analyzing data are blind to treatment allocation.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
for FM patients: 1. Aged 18-65 2. Female 3. Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al. 2011 research criteria for fibromyalgia 4. On stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial 5. Right-handed 6. Baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days 7. Able to provide written consent
Exclusion criteria
for FM: 1. Comorbid acute pain condition 2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia 3. Current use of prescription stimulant medications (e.g., modafinil) 4. Routine use of substances of abuse 5. Certain condition that interfere with Quantitative Sensory Testing (QST) and/or fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or/and any impairment, activity or situation that could prevent satisfactory completion of the study protocol Inclusion Criteria for Healthy Control Participants 1. Aged 18-65 2. Female 3. Right-handed 4. Able to provide written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical outcome: Brief Pain Inventory (BPI) | Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment | Pain-related interference and pain severity |
| Neurobiological Outcome: Pain Neurocircuitry (fMRI) | Post-treatment | Bold responses will be assessed with fMRI (3T) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Catastrophizing (PCS) | 4 weeks (mid-treatment), as well as Post-treatment | Catatrophizing will be assessed with the Pain Catastrophizing Scale (PCS).Investigators hypothesize that early-treatment changes in catastrophizing will produce adaptive brain changes at post-treatment |
Countries
United States
Outcome results
None listed