Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Given recent increasing opioid-related deaths and evidence showing against the use of opioids
      for non-malignant chronic pain, there is growing need for non-narcotic pain management.
      Fibromyalgia is a difficult to treat chronic pain condition that is often treated with
      opioids despite existing evidence. The prevalence of fibromyalgia is increased among Veterans
      returning from the gulf war and is already a significant burden in senior Veterans who may
      have suffered with chronic pain for decades already. Many treatment options for fibromyalgia
      carry intolerable side effects. PENFS (percutaneous electrical neural field stimulation) is a
      FDA-approved, non-pharmacologic therapy that is currently utilized within the military and VA
      system, but sufficient evidence regarding its outcomes and neural mechanisms have not been
      adequately investigated. An understanding of its neural underpinnings and analgesic effects
      could lead to 1) improvements in pain management and quality of life, 2) cost-savings and 3)
      development of new techniques to address pain.
    

Detailed description: 
      BACKGROUND: Fibromyalgia is a chronic pain syndrome that consists of chronic widespread pain,
      decreased physical function, fatigue, psychoemotional/sleep disturbances, and various somatic
      complaints, affecting anywhere from 5-10 million Americans, with ~1,500 Veterans carrying a
      diagnosis of fibromyalgia seen per year at the Atlanta VAMC alone. It is estimated that
      fibromyalgia costs the American population over $20 billion/year in lost wages and
      disability. Initial therapies often include complementary and alternative medicine (CAM)
      therapies, which are generally considered safe, although their efficacy has not been
      thoroughly evaluated for fibromyalgia. Thus, non-pharmacologic alternatives require more
      rigorous scientific investigation for the treatment of fibromyalgia. There is evidence to
      support the use of percutaneous electrical neural stimulation (PENS) in the treatment of pain
      conditions, which may have increased effects relative to acupuncture based on systematic
      reviews. While fMRI data for acupuncture and fibromyalgia exists, no such data exists for
      PENS treatment. An evolved form of PENS, percutaneous electrical neural field stimulation
      (PENFS) of the auricle is already used in the military and VA systems for the treatment of
      chronic pain, but evidence regarding its mechanisms and effects is lacking. Stimulation of
      the vagus nerve, which has auricular branches, has been previously studied for pain relief in
      fibromyalgia. However, application of PENS-type stimulation to the auricle has not been
      previously studied with fMRI, and this type of therapy may lead to neural changes worthy of
      further exploration. OBJECTIVE: To evaluate the feasibility of using fMRI as a biomarker for
      the neural substrates of pain and functional changes following PENFS treatments. HYPOTHESIS:
      PENFS will result in decreased functional connectivity between the insula and default mode
      network as evaluated by fMRI, which will correlate to more significant improvements in pain
      and function relative to standard therapy for fibromyalgia. METHODS: Subjects who meet study
      criteria will receive baseline assessments including resting state fMRI, collection of
      biobehavioural information such as cognitive and psychological assessments on standardized
      forms, eating, sleeping and drinking habits, Defense and Veterans Pain Rating Scale (DVPRS),
      arm curl, 30-s chair stand, and pain interference scores. Subjects will be stratified based
      on age and gender and then divided into standard therapy control (medication management and
      physical therapy) or PENFS (series of 4, weekly) treatments and assessed for fMRI changes 2
      weeks after the final treatment. Pain and function will also be assessed at the 2 weeks, 6
      weeks and 12 weeks following the final treatment. CLINICAL RELEVANCE: Auricular PENFS has not
      been studied with fMRI. Stimulation of the auricle may produce neural changes that differ
      from traditional therapies. Understanding the underlying neural mechanisms of auricular PENFS
      could assist in developing targeted treatments for fibromyalgia and chronic pain. Further, if
      PENFS can significantly improve pain relief and function over standard therapies, it could
      decrease the need for opioid analgesics and their associated risks, which is a primary
      objective of the VA Opioid Safety Initiative. The present investigation will not only serve
      to elucidate neural changes with PENFS, but could be directly applicable to our Veterans
      suffering from fibromyalgia by providing evidence regarding the relative effectiveness of
      this already clinically-employed non-pharmacologic treatment (or lack thereof), and result in
      evidence-based implementation and potential cost savings to the VA system.
    

Intervention name(s): Military Field Stimulator; Standard Therapy
Intervention type(s): Device; Other
Intervention description(s): The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military and used in the VA (contract number V797D-50453). There is some evidence based on a small trial of 20 postoperative patients that suggests PENS may have greater benefit than acupuncture for acute pain.; Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.
Other intervention name(s): MFS, Neuro-Stim System, PENFS
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Percutaneous electrical neural field stimulator (PENFS) using the military field stimulator, a device that uses small needles inserted in the ear (like auricular acupuncture), which are connected by electrodes to a battery pack that is attached externally using adhesive to the back of the ear. The stimulator is meant to stimulate branches of the cranial nerves via the ear.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment