Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02064296|
Recruitment Status : Recruiting
First Posted : February 17, 2014
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: Needle acupuncture (Traditional Acupuncture) Device: Laser acupuncture (Non-traditional Acupuncture)||Not Applicable|
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 40 pain-free controls.
Participants will undergo experimental pain assessments as well as brain neuroimaging.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||April 2020|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|