Status:
RECRUITING
Cognitive Training to Enhance Brain Concordance During Acupuncture
Lead Sponsor:
Spaulding Rehabilitation Hospital
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Fibromyalgia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study will evaluate the impact of a novel non-pharmacological multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic...
Detailed Description
The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neura...
Eligibility Criteria
Inclusion
- Meet traditional American College of Rheumatology (ACR) criteria for FM as well as the more recent Wolfe et al 2011 criteria
- Are on stable doses of medication for 30 days prior to entering the study and agree not 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
- Any longer period of work experience involving pain treatment, pain rehabilitation etc.
- 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 behavioral part 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 expectancy induction 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 than fibromyalgia
- 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, bipolar disorder, severe personality disorders)
- History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (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 or Principal 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
Key Trial Info
Start Date :
February 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06157866
Start Date
February 16 2024
End Date
June 30 2027
Last Update
October 24 2025
Active Locations (3)
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1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
2
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, United States, 02129
3
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467