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Trial record 11 of 104 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia (fMRI)

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by VA Office of Research and Development
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT03008837
First received: December 14, 2016
Last updated: June 8, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Fibromyalgia Device: Military Field Stimulator Other: Standard Therapy

Study Type: Interventional
Study Design: 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
Official Title: Feasibility Study: fMRI Evaluation of Auricular PENFS for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • fcMRI as a biomarker to investigate functionally correlated neural substrates of pain in patients undergoing PENFS [ Time Frame: 2 years ]
    2 weeks following the final treatment, subjects will be evaluated for decreases in functional connectivity between the default mode network (DMN) and posterior insula as evaluated by fcMRI relative to standard treatment (medication, physical therapy) controls and these intra-subject changes are expected to correlate with patient-reported analgesic and functional improvements as indicated in Outcomes 2 & 3.


Secondary Outcome Measures:
  • Defense Veterans Pain Rating Scale (DVPRS) [ Time Frame: 2 years ]
    For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic DVPRS at 2, 6 and 12 weeks follow-up.

  • PROMIS measures [ Time Frame: 2 years ]
    For fibromyalgia patients, function will be assessed in the PENFS group relative to standard treatment controls, as indicated by standardized, validated sub-groups of questions from the PROMIS measures , provided by the NIH. at 2, 6 and 12 weeks follow-up

  • Analgesic Consumption [ Time Frame: 2 years ]
    For fibromyalgia patients, pain will be assessed in the PENFS group relative to standard treatment controls, as indicated by analgesic consumption at 2, 6 and 12 weeks follow-up.

  • International Classification of Functioning, Disability, and Health [ Time Frame: 2 years ]
    Function will be assessed using measures describing a person's functional status from the realms "Activity and Participation" from the International Classification of Functioning, Disability, and Health at 2, 6 and 12 weeks follow-up.

  • Functional Tests [ Time Frame: 2 years ]
    Objective tests for functional improvement will be performed at 2, 6, and 12 weeks follow-up and include the arm curl, 30-s chair stand, and handgrip strength tests.


Estimated Enrollment: 20
Actual Study Start Date: June 1, 2017
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: December 7, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PENFS
Veterans with fibromyalgia who meet study criteria and are randomized to the experimental group will receive standard therapy in addition to percutaneous electrical neural field stimulation (PENFS), which involves placement of small electrodes through a similar process to ear acupuncture to the ear. These electrodes are attached to a battery pack that is taped behind the ear and worn for 5-day intervals. The intention of this FDA-approved device is to relieve pain, though data on its effectiveness is still limited. Device placement (series of 4, weekly) will be performed by an Anesthesiology Pain Clinic provider. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
Device: Military Field Stimulator
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.
Other Name: MFS, Neuro-Stim System, PENFS
Active Comparator: Standard Therapy
Veterans with fibromyalgia who meet study criteria and are randomized to standard therapy will receive physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist. fMRI evaluation of neural changes, assessment of function and quality of life improvements will be performed at the beginning and end of the study.
Other: Standard Therapy
Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.

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), PROMIS measures, arm curl, 30-s chair stand, and handgrip strength tests, [measures from the realms "Activity and Participation" from the International Classification of Functioning, Disability, and Health,] and baseline analgesic consumption. 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.
  Eligibility

Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be male and female Veterans age 20-60 with a diagnosis of fibromyalgia as diagnosed by a clinician, by chart review, and by the most recent American College of Rheumatology 2010 criteria for the diagnosis of fibromyalgia. 70,71
  • Subjects must self-report consistent, daily pain (greater than 5 on the VAS) >90 days.
  • Subjects must have intact skin free of infection at the site of implantation.
  • Subjects must be willing to participate and understand the consent.
  • Subjects must be right-handed in order to provide consistency in brain structure and function.

Exclusion Criteria:

  • Subjects must not be currently pregnant, since effects of fMRI and electrical current on the developing fetus are not well-known.
  • Subjects must not have an implanted electrical device such as a vagal stimulator, pacemaker, or spinal pain pump, which are not compatible with MRI.
  • Subjects must not have a history of seizures or neurologic condition that may alter the structure of the brain.
  • Subjects must not have a history of drug abuse or severe, uncontrolled psychiatric illness such as schizophrenia or major depressive disorder with suicidal ideation.
  • Subjects must not have psoriasis vulgaris or other skin conditions that may increase the risk of infection at the implantation site.
  • Subjects must not have severe anxiety, claustrophobia, or other conditions that may prevent their ability to lie at rest in an MRI scanner. This will be determined after discussion with the patient regarding their own perceived ability to lie at rest in an MRI scanner without the use of additional sedating medications.
  • Subjects must not introduce new medications or treatments for fibromyalgia symptoms during the course of the study to prevent confounding results.
  • Subjects must not have a concurrent autoimmune or inflammatory disease that causes pain such as systemic lupus erythematosus, inflammatory bowel disease or rheumatoid arthritis, since this could decrease the effect of treatment.
  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: NCT03008837

Contacts
Contact: Anna Woodbury, MD (404) 321-6111 ext 6939 Anna.Woodbury@va.gov

Locations
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA Recruiting
Decatur, Georgia, United States, 30033
Contact: Anna Woodbury, MD    404-321-6111 ext 6939    Anna.Woodbury@va.gov   
Principal Investigator: Anna Woodbury, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Anna Woodbury, MD Atlanta VA Medical and Rehab Center, Decatur, GA
  More Information

Additional Information:
Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03008837     History of Changes
Other Study ID Numbers: F2113-M
1IK1RX002113-01A2 ( U.S. NIH Grant/Contract )
Study First Received: December 14, 2016
Last Updated: June 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 23, 2017