Cognitive Training to Enhance Brain Concordance During Acupuncture

Fibromyalgia Clinical Trial

Official title:

Cognitive Training to Enhance Brain-to-brain Concordance During Acupuncture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157866
• Other study ID #: 2023P003155
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: February 2024
• Source: Spaulding Rehabilitation Hospital
• Contact: Seneca Ellis
• Phone: 617-952-6484
• Email: sellis11[@]mgb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

The patient-clinician interaction is central to most therapies and is supported by key interpersonal mechanisms of action such as clinician empathy, therapeutic alliance, and trust. However, the neural underpinnings of this effect are mostly unknown. The investigators' recently published study applied functional MRI (fMRI) hyperscanning (i.e. simultaneously neuroimaging chronic pain patients and clinicians in synchronized MRI scanners) demonstrated that brain-to-brain concordance in the temporoparietal junction (TPJ) is up-regulated following a clinical interaction and associated with patient analgesia. Fibromyalgia is a chronic pain disorder in great need of novel therapies. This study will evaluate the impact of a novel multimodal therapy, a type of approach known to improve pain outcomes and recommended by the Institute of Medicine report for chronic pain management. The study design will also allow the investigators to evaluate a neural model supporting therapeutic alliance for pain outcomes for fibromyalgia wherein training and acupuncture will synergistically target a critical therapeutic pathway - i.e., patient-provider alliance, instantiated by TPJ concordance.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• Electroacupuncture
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.

Behavioral:
• Cognitive Training
Cognitive training with a pain specialist.
• Education Training
Education training with a pain specialist.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts
United States	Spaulding Rehabilitation Hospital	Charlestown	Massachusetts
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Up to 6 months
Primary	Brain Imaging-fMRI	Hyperscan fMRI assessing brain-to-brain concordance between the patient and the clinician.	Up to 6 months
Secondary	Brain Imaging-EEG	Hyperscan EEG assessing brain-to-brain concordance between the patient and the clinician.	Up to 6 months