Last updated: February 22, 2024
Sponsor: Spaulding Rehabilitation Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Fibromyalgia
Treatment
Cognitive Training
Education Training
Electroacupuncture
Clinical Study ID
NCT06157866
2023P003155
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Meet traditional American College of Rheumatology (ACR) criteria for FM as well as themore recent Wolfe et al 2011 criteria
- Are on stable doses of medication for 30 days prior to entering the study and agreenot to change medications or dosages during the trial
- Ability to fully understand and consent to study procedures
- Baseline pain intensity of at least 4/10
- Pain duration of at least 6 months
Exclusion
Exclusion Criteria:
- Any longer period of work experience involving pain treatment, pain rehabilitationetc.
- Presence of any illness that is judged to interfere with the trial. For example:psychiatric disorder according to the DSM-IV manual
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker,metal implants, fear of closed spaces, pregnancy.
- History of significant head injury
- Inability to respond accurately to the pain-relieving intervention in the behavioralpart of the experiment, indicating a lack of response to the expectancy manipulation.If the healthy volunteer or clinician is not a responder to the behavioral expectancyinduction he or she will be excluded.
- Unwillingness to receive brief experimental pain.
- Leg pain or health issues that may interfere with the study procedures.
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful thanfibromyalgia
- Current use of opioid analgesics
- Concurrent inflammatory or autoimmune disease
- Documented peripheral neuropathy
- Pregnant
- Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolardisorder, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRIprocedures (e.g., panic)
- Psychiatric hospitalization in the past 6 months
- Unwillingness to withhold from consuming marijuana 12 hours prior to scans
- Unwillingness to withhold from consuming nicotine 4 hours prior to scans
- Any impairment, activity or situation that in the judgment of the Study Coordinator orPrincipal Investigator would prevent satisfactory completion of the study protocol.
- Is an actual clinical patient of the clinician subject
- Recent history of formal meditation-based training
Study Design
Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Cognitive Training
Phase:
Study Start date:
February 16, 2024
Estimated Completion Date:
June 30, 2027
Study Description
Connect with a study center
Massachusetts General Hospital
Charlestown, Massachusetts 02129
United StatesActive - Recruiting
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts 02129
United StatesActive - Recruiting
Brigham and Women's Hospital
Chestnut Hill, Massachusetts 02467
United StatesActive - Recruiting
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