Clinical trial NCT02908022: Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy
Official title: Optimization of Brain-based Mechanisms Supporting Psychosocial Aspects of Acupuncture Therapy - a Hyperscanning fMRI Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physician-patient Relationship
Fibromyalgia
Acupuncture Therapy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2016-09-20
Enrollment: 180
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: First phase: At the training sessions, both clinician and patient will fill out a set of questionnaires and go through standardized psychophysical tests for assessing visual displays of affect. They will also be informed of the efficacy of the electroacupuncture in relieving pain during the experiment. During the clinical examination, the clinician will follow clinical exam protocol and do an intake of the fibromyalgia (FM) patient, including a physical exam and pain assessment. While in the scanner, the clinician will receive painful stimulations with a pressure cuff on the leg over an 8-minute paradigm in order to get cerebral representation. The patient will then be placed in a different scanner running simultaneously and will experience painful stimulations with a pressure cuff while interacting via live camera with the clinician in the other scanner. When visually prompted via cues on a screen, the clinician will activate analgesia for the patient, through a response device (response box) in clinician's one hand. After each trial of pain with/without treatment, the clinicians will be asked "how did you feel about the outcome (extremely positive - extremely negative)", and how satisfied are you (Not at all satisfied - Very satisfied) on Numerical Rating Scales (NRS). The patient will also give ratings after each trial of pain with/without treatment. They will be asked "how did you feel about the outcome (extremely positive - extremely negative)?", and "how painful was the cuff (Not painful - Extremely painful)?" on NRS. After the scan, both clinician and patient will be asked to rate anxiety during the presence of visual stimulus preceding cuff activation (not at all anxious - extremely anxious). After the final MRI session, the clinician and the patient will both be given the chance to report their responses to the treatment and then debriefed.

Second phase: At training session both clinician and patient will fill out a set of questionnaires. During the first MRI session the clinician will receive painful stimulations with a pressure cuff on the leg over a 6-minute paradigm in order to get cerebral representation. The patient will then be placed in a different scanner running simultaneously and will experience pain stimulation with the pressure cuff while interacting via live camera with the clinician in the other scanner. When visually prompted via cues on a screen, the clinician will activate analgesia for the patient, through a response device (response box) in clinician's hand. Both patient and acupuncturist will be asked to give ratings of pain and other parameters during the scan. 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.

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

Primary outcomes:
measure: Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy
timeFrame: Up to 60 months
Secondary outcomes:
measure: Correlation between patient/clinician brain activity concordance and pain relief from electroacupuncture therapy
timeFrame: Up to 60 months
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Martinos Center for Biomedical Imaging
state: Massachusetts
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Vitaly Napadow, PhD, LicAc
role: PRINCIPAL_INVESTIGATOR
References:
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