Cognitive Training to Enhance Brain Concordance During Acupuncture

Recruiting now · Not applicable

Conditions studied: Fibromyalgia

In brief

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.

Key facts

Study ID

NCT06157866

Run by

Spaulding Rehabilitation Hospital

People needed

100

Starts

2024-02-16

Expected to finish

2027-06-30

Last updated by the study team

2025-10-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Massachusetts General Hospital — Charlestown, Massachusetts, United States (enrolling)
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (enrolling)
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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