Cognitive Training to Enhance Brain Concordance During Acupuncture
Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
Spaulding Rehabilitation Hospital
100 participants
Feb 16, 2024
INTERVENTIONAL
Conditions
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 pain management. This study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia.
Eligibility
Inclusion Criteria5
- 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 Criteria21
- 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
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Interventions
During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. A low-amplitude, sub-sensory electrical current will be activated by the acupuncturist.
Cognitive training with a pain specialist.
Education training with a pain specialist.
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06157866