Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia



Status:Recruiting
Conditions:Fibromyalgia, Pain
Therapuetic Areas:Musculoskeletal, Rheumatology
Healthy:No
Age Range:18 - 65
Updated:10/28/2018
Start Date:May 2014
End Date:April 2019
Contact:Olivia J Franceschelli, B.S.
Email:ofranceschelli@partners.org
Phone:617-732-9718

Use our guide to learn which trials are right for you!

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 90 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 30 pain-free controls and 60 education program controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.

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.

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 opioid analgesics or stimulant medications or the fatigue associated
with sleep apnea or shift work (e.g., modafinil)

4. Routine or daily use of narcotics, marijuana or substances of abuse

5. Certain condition that intervene 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 (e.g unreliable, or inconsistent pain scores).

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 opioid analgesics or stimulant medications or the fatigue associated
with sleep apnea or shift work (e.g., modafinil)

3. Routine or daily use of narcotics, marijuana or substances of abuse

4. Certain condition that intervene with Quantitative Sensory Testing (QST) and fMRI
procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc)
or any impairment, activity or situation would prevent satisfactory completion of the
study protocol (e.g unreliable, or inconsistent pain scores). This includes
unreliable, or inconsistent pain scores as deemed by the principal investigator.
We found this trial at
2
sites
Charlestown, Massachusetts 02129
Principal Investigator: Vitaly Napadow, PhD, Lic.Ac
?
mi
from
Charlestown, MA
Click here to add this to my saved trials
Chestnut Hill, Massachusetts 02467
Principal Investigator: Robert R Edwards, PhD
Phone: 617-643-5920
?
mi
from
Chestnut Hill, MA
Click here to add this to my saved trials