Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
|Fibromyalgia||Device: Needle acupuncture (Traditional Acupuncture) Device: Laser acupuncture (Non-traditional Acupuncture)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain|
- Neurocircuitry underlying chronic pain [ Time Frame: At baseline ]Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM.
- Change in brain connectivity and neurochemistry with acupuncture treatment [ Time Frame: 4 weeks ]Brain neurochemistry and connectivity will be assessed at baseline and following either electroacupuncture or laser acupuncture.
- Predicting response to acupuncture [ Time Frame: 4 weeks ]Baseline neuroimaging outcomes of connectivity and neurochemistry will be used to predict subsequent response to electroacupuncture and laser acupuncture.
|Study Start Date:||December 2014|
|Estimated Study Completion Date:||July 2019|
|Estimated Primary Completion Date:||October 2018 (Final data collection date for primary outcome measure)|
No Intervention: Controls
Healthy pain free controls will be recruited for comparison with fibromyalgia patients.
Active Comparator: Non-Traditional Acupuncture
40 fibromyalgia patients will be randomized to non-traditional laser acupuncture (Vita Laser 650, Lhasa OMS). They will receive 2 treatments per week for 4 weeks.
Device: Laser acupuncture (Non-traditional Acupuncture)
For non-traditional acupuncture, a laser acupuncture device will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.
Active Comparator: Traditional Acupuncture
40 fibromyalgia patients will be randomized to receive electro acupuncture (AS Super 4 digital needle stimulator, Harmony Medical Co) . They will receive 2 treatments per week for 4 weeks.
Device: Needle acupuncture (Traditional Acupuncture)
This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device.
This study design has two components: 1) a cross sectional assessment of brain chemistry, connectivity and response to pain in healthy controls and age- and sex-matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either electro-acupuncture or laser acupuncture.
The investigators will evaluate 80 fibromyalgia patients who will receive acupuncture treatment twice a week for 4 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from 20 pain-free controls.
Participants will undergo experimental pain assessments as well as brain neuroimaging.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02064296
|Contact: U-M CPFRCfirstname.lastname@example.org|
|United States, Michigan|
|Chronic Pain and Fatigue Research Center||Recruiting|
|Ann Arbor, Michigan, United States, 48106|
|Contact: CPFRC 866-288-0046 email@example.com|
|Principal Investigator: Richard E Harris, PhD|
|Sub-Investigator: Steve E Harte, phD|
|Sub-Investigator: Bradly Foerster, MD|
|Sub-Investigator: Alex Tsodikov, PhD|
|Sub-Investigator: Daniel J Clauw, MD|
|Principal Investigator:||Richard E Harris, PhD||University of Michigan|
|Principal Investigator:||Viataly Napadow, PhD||Massachusetts General Hospital|