Brain Mechanisms of Psychosocial Aspects of Acupuncture Therapy
- Conditions
- Acupuncture TherapyPhysician-patient RelationshipFibromyalgia
- Interventions
- Device: Electroacupuncture AnalgesiaDevice: Hokanson Rapid Cuff Inflator
- Registration Number
- NCT02908022
- Lead Sponsor
- Massachusetts General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 180
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Interaction Hokanson Rapid Cuff Inflator 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. Longitudinal Electroacupuncture Analgesia 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. Interaction Electroacupuncture Analgesia 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. No Interaction Hokanson Rapid Cuff Inflator 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. No Interaction Electroacupuncture Analgesia 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. Longitudinal Hokanson Rapid Cuff Inflator 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.
- Primary Outcome Measures
Name Time Method Magnitude of patient/clinician concordance in brain activation of mirror brain circuitry during electroacupuncture therapy Up to 60 months 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
Name Time Method Correlation between patient/clinician brain activity concordance and pain relief from electroacupuncture therapy Up to 60 months Patient/clinician concordance in brain activation will be assessed by functional Magnetic Resonance Imaging, simultaneously for both the patient and the clinician
Trial Locations
- Locations (2)
Martinos Center for Biomedical Imaging
🇺🇸Charlestown, Massachusetts, United States
Spaulding Rehabilitation Hospital
🇺🇸Charlestown, Massachusetts, United States