Acupuncture's pain relief tied to brain synchrony between patient and practitioner
NCT ID NCT02908022
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how the brains of fibromyalgia patients and their acupuncturists work together during electroacupuncture treatment. Using special MRI scans that record both people at once, researchers hope to see if matching brain activity leads to better pain relief. The goal is to understand the social and psychological aspects of acupuncture, not to test a new drug or cure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- electroacupuncture
- What this could lead to
- If successful, this could help explain how the patient-clinician interaction enhances acupuncture's pain-relieving effects.
- What could go wrong
- This is an observational study focused on brain mechanisms, not a treatment trial. Results may not lead to new therapies or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Start date
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Sep 2016
- Finished
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May 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129, United States
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Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a Hands-On nerve technique ease Fibromyalgia's grip?
- Why some days hurt more: charting Fibromyalgia's daily swings
- Zapping the vagus nerve: a new hope for fibromyalgia pain?