Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Charlestown, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 180 people, planned
- Started
- Sept 2016
- Ended
- May 2024
- Type of study
- Interventional, 3 groups
- Treatments tested
- Electroacupuncture Analgesia
- Hokanson Rapid Cuff Inflator
- Record updated
- 16 October 2025
Who can take part
- Age
- 21 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 47 criteriaShow less
Who can take part
- 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
- 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
- Male and female healthy clinicians
- 25-65 years of age (clinicians)
- 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
- 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
- 21-65 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
Who cannot take part
- Current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
- Marijuana use greater than once daily and unwillingness to withhold from consumption 12 hours prior to scans or lab visits
- Unwillingness to withhold from consuming nicotine 4 hours prior to scans
- 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
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- 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
- 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
- Comorbid acute pain condition
- Comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
- 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
- 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
- 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
- Documented peripheral neuropathy
- Is an actual clinical patient of the clinician subject; Phase 2:
- 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
- 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
- Unwillingness to receive brief experimental pain
- Leg pain or health issues that may interfere with the study procedures
- Documented peripheral neuropathy
- Is an actual clinical patient of the clinician subject
Other criteria
- Phase 1:
Where in United States
- Martinos Center for Biomedical ImagingCharlestown, United StatesNo longer taking part
- Spaulding Rehabilitation HospitalCharlestown, United StatesNo longer taking part
About the trial
What the trial wants to find out
The overall aim of the present proposal is to investigate how patients' and clinicians' (Licensed acupuncturists, LAc) neural and autonomic processes during treatment interaction correlate to patient outcomes. Male and female healthy clinicians and fibromyalgia patients will be recruited for the study.
The 3 groups in the trial
- InteractionTreatment being tested
Phase 1: Prior to the MRI sessions, the clinician will be introduced to the patient and do a general intake of physical examination. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.
Treatment: Electroacupuncture Analgesia and Hokanson Rapid Cuff Inflator
- No InteractionTreatment being tested
Phase 1: The clinician and the patient will first be introduced at the MRI sessions. During the MRI sessions, the patient will receive experimental pressure pain via the Hokanson Rapid Cuff Inflator and electroacupuncture analgesia to the leg for pain relief.
Treatment: Electroacupuncture Analgesia and Hokanson Rapid Cuff Inflator
- LongitudinalTreatment being tested
Phase 2: Prior to first MRI session, both clinician and patient will go through a training visit. During the first MRI session, the patient will receive experimental pressure pain to the left leg via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief. Following the first MRI session, the patient will attend biweekly acupuncture treatment sessions with the clinician (6 treatments total). During the first session the clinician will be introduced to the patient and do a general intake in addition to the acupuncture treatment. The final MRI session will be identical to the first. The patient will receive experimental pressure pain via Hokanson Rapid Cuff Inflator and electroacupuncture to the same leg for pain relief.
Treatment: Electroacupuncture Analgesia and Hokanson Rapid Cuff Inflator
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Optimization of Brain-based Mechanisms Supporting Psychosocial Aspects of Acupuncture Therapy - a Hyperscanning fMRI Study
- Record updated
- 16 October 2025