Investigating brain mechanisms in acupuncture therapy for fibromyalgia

Optimization of Brain-based Mechanisms Supporting Psychosocial Aspects of Acupuncture Therapy - a Hyperscanning fMRI Study

This study is testing how acupuncture affects pain in people with fibromyalgia by looking at the brain activity of both patients and doctors during treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 21 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 2 sites (Charlestown, Massachusetts and 1 other locations)
• Trial ID: NCT02908022 on ClinicalTrials.gov

What this trial studies

This study aims to explore the neural and autonomic processes of both clinicians and fibromyalgia patients during acupuncture treatment interactions and how these correlate with patient outcomes. Healthy clinicians and fibromyalgia patients will participate in a series of assessments, including questionnaires and psychophysical tests. During the experiment, both parties will undergo painful stimulations while interacting via live camera, allowing researchers to analyze the effects of clinician-activated analgesia on patient pain perception. The study will utilize advanced imaging techniques to capture cerebral responses during these interactions.

Who should consider this trial

Good fit: Ideal candidates include right-handed adults aged 21 to 60 with a clinical diagnosis of fibromyalgia who have been stable on their medications for at least 30 days.

Not a fit: Patients with extensive experience in pain treatment or rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of how psychosocial factors in acupuncture therapy influence pain relief in fibromyalgia patients.

How similar studies have performed: While there is ongoing research into the psychosocial aspects of acupuncture, this specific approach combining neuroimaging with clinician-patient interactions is relatively novel.

Eligibility criteria

Phase 1:

Inclusion Criteria (Healthy Clinicians):

* Male and Female healthy clinicians
* 25-60 years of age
* Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.

Inclusion Criteria (Fibromyalgia Patients):

* Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
* 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
* 21 to 60 years of age
* Right-handed
* Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures

Exclusion Criteria (All participants):

* Any longer period of work experience involving pain treatment, pain rehabilitation etc. This is in order to exclude participants with biased expectations regarding different methods of analgesia
* Presence of any illness or medication use that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual, medication that can influence cognition or emotional processing, i.e. sleep medication, antidepressants, anti-convulsants or opioids
* Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
* 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

Exclusion Criteria (Specific to Fibromyalgia Patients):

* Comorbid acute pain condition
* Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
* Current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
* Documented peripheral neuropathy
* 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
* 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

Phase 2:

Inclusion Criteria (healthy individuals):

1. Male and female healthy clinicians.
2. 25-65 years of age (clinicians)
3. Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.

Inclusion Criteria (FM patients):

1. Have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia for at least one year
2. 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
3. 21-65 years of age
4. Ability to read and understand English; English can be a second language provided that the participant feels that he/she understand all the questions used in the assessment measures.

Exclusion Criteria (all participants):

1. Any longer period of work experience involving pain treatment, pain rehabilitation etc. This is in order to exclude participants with biased expectations regarding different methods of analgesia.
2. Presence of any illness that is judged to interfere with the trial. For example: psychiatric disorder according to the DSM-IV manual
3. Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
4. 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 in-duction he or she will be excluded.
5. Unwillingness to receive brief experimental pain.
6. Leg pain or health issues that may interfere with the study procedures.

Exclusion Criteria (specific to FM patients):

1. Comorbid acute pain condition
2. Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
3. Documented peripheral neuropathy
4. Any psychiatric disorder involving a history of psychosis (e. g schizophrenia, bipolar disorder, severe personality disorders)
5. History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
6. Psychiatric hospitalization in the past 6 months
7. Marijuana use greater than once daily and unwillingness to withhold from consumption 12 hours prior to scans or lab visits
8. Unwillingness to withhold from consuming nicotine 4 hours prior to scans
9. Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol.
10. Is an actual clinical patient of the clinician subject

Where this trial is running

Charlestown, Massachusetts and 1 other locations

• Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States (Recruiting)
• Spaulding Rehabilitation Hospital — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Vitaly Napadow, PhD, LicAc — Spaulding Rehabilitation Hospital
• Study coordinator: Seneca Ellis

Conditions Physician-patient Relationship; Fibromyalgia; Acupuncture Therapy