Cognitive Training to Enhance Brain Concordance During Acupuncture
RecruitingNot applicableNCT06157866
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
- Conditions
- Interventions
- Other: Electroacupuncture
- Behavioral: Cognitive Training
- Behavioral: Education Training
- Sponsor
- Spaulding Rehabilitation Hospital
- Collaborators
- National Institutes of Health (NIH)
- Start date
- 2024-02-16
- Primary completion
- 2027-06-30
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 3
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Criteria: * 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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06157866