Cognitive training and acupuncture for fibromyalgia pain relief

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.