Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by University of Michigan
Sponsor:
Collaborators:
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Information provided by (Responsible Party):
Richard Harris, University of Michigan
ClinicalTrials.gov Identifier:
NCT02064296
First received: February 11, 2014
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
The aim of this study is to evaluate the impact of electro-acupuncture in pain processing on patients with fibromyalgia (FM). The investigators hypothesize that electro-acupuncture is effective for FM because it functions as a desensitization therapy, which when applied repeatedly over multiple treatment sessions, gradually habituates the nervous system to continuing pain and sensory signaling.

Condition Intervention
Fibromyalgia
Device: Needle acupuncture (Traditional Acupuncture)
Device: Laser acupuncture (Non-traditional Acupuncture)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Neuroimaging Approaches to Deconstructing Acupuncture for Chronic Pain

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Neurocircuitry underlying chronic pain [ Time Frame: At baseline ] [ Designated as safety issue: No ]
    Characterize the altered somatosensory-related neurocircuitry underlying chronic pain in FM.

  • Change in brain connectivity and neurochemistry with acupuncture treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Brain neurochemistry and connectivity will be assessed at baseline and following either electroacupuncture or laser acupuncture.


Secondary Outcome Measures:
  • Predicting response to acupuncture [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Baseline neuroimaging outcomes of connectivity and neurochemistry will be used to predict subsequent response to electroacupuncture and laser acupuncture.


Estimated Enrollment: 100
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)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Fibromyalgia Participants

  • Have a Fibromyalgia diagnosis for at least one year and also meet the Wolfe et al 2011 criteria for Fibromyalgia.
  • Continued presence of pain more than 50% of days.
  • Pain greater than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall; [Note: The VAS is widely used in clinical pain research and as such we chose to use it for inclusion criteria and for clinical pain assessment below. Within our group numerical ratings scales 0-100 are more commonly used in quantitative sensory assessment, and as such we chose to use NRS scales for evoked pain assessments below.]
  • Willing to limit the introduction of any new medications or treatment modalities for control of FM symptoms during the study.
  • Able to travel to the study site to receive acupuncture treatments up to two times weekly.
  • Over 18 and under 65 years of age.
  • Right-handed.
  • Female.
  • Capable of giving written informed consent.

Inclusion Criteria for Healthy Control Participants

  • Over 18 and under 65 years of age.
  • Female.
  • Right-handed.
  • Do not have fibromyalgia or an associated pain disorder, including: migraine, temporomandibular joint disorder (TMJ), chronic pelvic pain (CPP), or chronic fatigue syndrome (CFS).
  • Pain less than a certain threshold on the Visual Analog Scale (VAS) for pain; 7-day recall
  • Willing to complete all study procedures.
  • Capable of giving written informed consent.

Exclusion Criteria for Fibromyalgia Participants:

  • Acupuncture within last 6-months.
  • Presence of a known coagulation abnormality, thrombocytopenia, or bleeding diathesis that may preclude the safe use of acupuncture.
  • Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc., or any other chronic pain condition with pain greater than fibromyalgia pain.
  • Peripheral neuropathy of know cause that interferes with activities of daily living.
  • History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
  • History of head injury with substantial loss of consciousness.
  • Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
  • Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
  • Concurrent participation in other therapeutic trials.
  • Pregnant or nursing.
  • Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
  • Contraindications to fcMRI, fMRI, or 1H-MRS methods. These may include but are not limited to: surgical clips, surgical staples, metal implants, and certain metallic dental material. [Note: a more formal description of contraindications for MRI is present in our DSM Plan].
  • Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
  • Use of as needed narcotic pain medication 48 hours prior to MRI scan.
  • Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
  • Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
  • Contraindications to the Electrostimulator device: Participants with electrical implants (i.e. pacemakers, defibrillators), cardiac rhythmic disorders, seizure disorders, any skin disorder in the vicinity of the electrode or an malignant diseases in the region of application. (Fibromyalgia participants only)

Exclusion Criteria for Healthy Control Participants:

  • Have a diagnosis of fibromyalgia or meet the Wolfe et al 2011 criteria for Fibromyalgia.
  • Presence of a concurrent autoimmune or inflammatory disease such as rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, etc. that causes pain.
  • Routine daily use of narcotic analgesics, marijuana or have a history of substance abuse in the past 24 months as determine by subject self-report.
  • Stimulant medications, such as those used to treat ADD/ADHD (e.g., amphetamine/ dextroamphetamine [Adderall®], methylphenidate, dextroamphetamine), or the fatigue associated with sleep apnea or shift work (e.g., modafinil), are excluded.
  • Concurrent participation in other therapeutic trials.
  • Pregnant or nursing.
  • Peripheral neuropathy of know cause that interferes with activities of daily living.
  • History of vascular surgery in lower limbs or current lower limb vascular dysfunction.
  • History of head injury with substantial loss of consciousness.
  • Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, substance abuse within two years).
  • Contraindications to fcMRI, fMRI, or 1H-MRS methods. (see above section)
  • Use of over the counter pain medications (NSAIDs, etc.) on the day of MRI scan.
  • Use of as needed narcotic pain medication 48 hours prior to MRI scan.
  • Current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail. Exceptions, including brief and/or occasional use, may be permissible at the discretion of the principle investigator.
  • Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigator that would prevent satisfactory completion of the study protocol.
  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: NCT02064296

Contacts
Contact: U-M CPFRC 1-866-288-0046 acuafference@umich.edu

Locations
United States, Michigan
Chronic Pain and Fatigue Research Center Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: CPFRC    866-288-0046    acuafference@umich.edu   
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         
Sponsors and Collaborators
University of Michigan
National Center for Complementary and Integrative Health (NCCIH)
Massachusetts General Hospital
Investigators
Principal Investigator: Richard E Harris, PhD University of Michigan
Principal Investigator: Viataly Napadow, PhD Massachusetts General Hospital
  More Information

Responsible Party: Richard Harris, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02064296     History of Changes
Other Study ID Numbers: AcuAfference  R01AT007550 
Study First Received: February 11, 2014
Last Updated: January 27, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Fibromyalgia Chronic Pain

Additional relevant MeSH terms:
Chronic Pain
Fibromyalgia
Myofascial Pain Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on August 24, 2016