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Trial record 51 of 98 for:    fibromyalgia | Open Studies | Interventional Studies

Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by Massachusetts General Hospital
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Vitaly Napadow, Ph.D., Lic.Ac., Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT02908022
First received: September 8, 2016
Last updated: September 16, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention
Physician-patient Relationship
Fibromyalgia
Acupuncture Therapy
Device: Electroacupuncture Analgesia
Device: Hokanson Rapid Cuff Inflator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimization of Brain-based Mechanisms Supporting Psychosocial Aspects of Acupuncture Therapy - a Hyperscanning fMRI Study

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Patient/clinician concordance in brain activation will be assessed by functional Magnetic Resonance Imaging, simultaneously for both the patient and the clinician


Secondary Outcome Measures:
  • Correlation between patient/clinician brain activity concordance and pain relief from electroacupuncture therapy [ Time Frame: Up to 60 months ] [ Designated as safety issue: No ]
    Patient/clinician concordance in brain activation will be assessed by functional Magnetic Resonance Imaging, simultaneously for both the patient and the clinician


Estimated Enrollment: 180
Study Start Date: September 2016
Estimated Study Completion Date: September 2021
Estimated Primary Completion Date: September 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interaction

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.

Device: Electroacupuncture Analgesia
Acupuncture needles will be inserted next to the cuff placed on the leg and will be connected to electrodes. Low-amplitude electrical current will be activated when a button is pressed via a handheld device, controlled by the acupuncturist, in order to reduce pain, acting as an analgesic.
Device: Hokanson Rapid Cuff Inflator
The Hokanson Rapid Cuff Inflator will be placed on the lower right leg of the subject and utilized for pain testing purposes according to the protocol. Ascending pressures will be administered using the cuff to elicit different pain intensities.
Experimental: No Interaction

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.

Device: Electroacupuncture Analgesia
Acupuncture needles will be inserted next to the cuff placed on the leg and will be connected to electrodes. Low-amplitude electrical current will be activated when a button is pressed via a handheld device, controlled by the acupuncturist, in order to reduce pain, acting as an analgesic.
Device: Hokanson Rapid Cuff Inflator
The Hokanson Rapid Cuff Inflator will be placed on the lower right leg of the subject and utilized for pain testing purposes according to the protocol. Ascending pressures will be administered using the cuff to elicit different pain intensities.

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Genders Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02908022

Contacts
Contact: Kylie Isenburg 617-643-0569 kisenburg@mgh.harvard.edu
Contact: Dan-Mikael Ellingsen, PhD dellingsen@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Vitaly Napadow, PhD, LicAc Massachusetts General Hospital
  More Information

Publications:

Responsible Party: Vitaly Napadow, Ph.D., Lic.Ac., Associate Professor, Harvard Medical School; Director, Center for Integrative Pain NeuroImaging (CiPNI), Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02908022     History of Changes
Other Study ID Numbers: 2013P002316  R61AT009306 
Study First Received: September 8, 2016
Last Updated: September 16, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibromyalgia
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2017