Cognitive training and acupuncture for fibromyalgia pain relief
Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture
NA · Spaulding Rehabilitation Hospital · NCT06157866
This study is testing a new therapy that combines brain training and acupuncture to see if it can help people with fibromyalgia feel less pain by improving the connection between patients and their healthcare providers.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Spaulding Rehabilitation Hospital (other) |
| Locations | 3 sites (Charlestown, Massachusetts and 2 other locations) |
| Trial ID | NCT06157866 on ClinicalTrials.gov |
What this trial studies
This study evaluates a novel non-pharmacological multimodal therapy combining cognitive training and electroacupuncture to improve pain outcomes in fibromyalgia patients. It focuses on the patient-clinician interaction and its neural underpinnings, particularly the brain-to-brain concordance in the temporoparietal junction during therapeutic sessions. By using hyperscanning fMRI technology, the study aims to understand how therapeutic alliance influences pain relief. The approach is designed to enhance the effectiveness of treatment by fostering a strong connection between patients and providers.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with fibromyalgia who have stable medication regimens and experience moderate to severe pain.
Not a fit: Patients with psychiatric disorders or contraindications to fMRI scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide significant pain relief and improved quality of life for fibromyalgia patients.
How similar studies have performed: Other studies have shown promise in using multimodal therapies for chronic pain, but this specific approach combining cognitive training and acupuncture is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Charlestown, Massachusetts and 2 other locations
- Massachusetts General Hospital — Charlestown, Massachusetts, United States (RECRUITING)
- Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Vitaly Napadow, PhD — Spaulding Rehabilitation Hospital
- Study coordinator: Seneca Ellis
- Email: sellis11@mgb.org
- Phone: 617-952-6484
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia, hyperscan fmri, hyperscan EEG, acupuncture, fibromyalgia, chronic pain