Cognitive Training to Enhance Brain Concordance During Acupuncture

ConditionFibromyalgia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorSpaulding Rehabilitation Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Electroacupuncture
Other intervention
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
Behavioral
Cognitive training with a pain specialist.
Education Training
Behavioral
Education training with a pain specialist.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Cognitive TrainingExperimental treatment 2 interventions

Group B: Education TrainingActive comparator 2 interventions

Trial outcomes

Primary outcomes

Brain Imaging-fMRI

Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.

Time frame

Up to 6 months

Secondary outcomes

Brain Imaging-EEG

Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician.

Time frame

Up to 6 months

Other outcomes

Brief Pain Inventory (BPI) - Pain Interference

Brief Pain Inventory (BPI) is a validated 16 item questionnaire designed to assess the severity and interference of pain experienced. Pain interference is assessed on a scale from 0 (no interference) to 10 (severe interference).

Time frame

Up to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaulding Rehabilitation Hospital

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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