Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy



Status:Recruiting
Conditions:Fibromyalgia
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:21 - 60
Updated:3/29/2017
Start Date:September 2016
End Date:September 2021
Contact:Kylie Isenburg
Email:kisenburg@mgh.harvard.edu
Phone:617-643-0569

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

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.

At the training sessions, both clinicians and patients 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 FM patient; including a physical exam and pain
assessment. While in the scanner, the clinician will receive pain stimulation 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 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 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 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 the 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.

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
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Charlestown, Massachusetts 02129
Phone: 617-643-0569
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