Fibromyalgia Clinical Trial
Official title:
Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia
Verified date | February 2023 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 148 |
Est. completion date | December 1, 2021 |
Est. primary completion date | December 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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 Exclusion criteria for Healthy Control Participants: 1. Any acute or chronic pain condition (e.g., FM, arthritis) 2. Current use of stimulant medications 3. Routine use of substances of abuse 4. 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massaschusetts General Hospital | Charlestown | Massachusetts |
United States | Brigham and Women's Hospital | Chestnut Hill | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Massachusetts General Hospital, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical outcome: Brief Pain Inventory (BPI) | Pain-related interference and pain severity | Post-treatment, with long-term exploratory outcomes at 6 Months Post-treatment | |
Primary | Neurobiological Outcome: Pain Neurocircuitry (fMRI) | Bold responses will be assessed with fMRI (3T) | Post-treatment | |
Secondary | Catastrophizing (PCS) | 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 | 4 weeks (mid-treatment), as well as Post-treatment |
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