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Auricular Nerve Stimulation for Chronic Pain

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ClinicalTrials.gov Identifier: NCT03959111
Recruitment Status : Not yet recruiting
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Brief Summary:
This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous nerve stimulation on chronic low back pain. We believe that this study, if successful, will provide new treatment options for chronic low back pain, reduce the use of opioid analgesics in chronic pain management, and enhance our understanding of the underlying mechanism of nerve stimulation treatment, as well as the pathophysiology and development of chronic pain.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Stimulation at Location 1 Other: Stimulation at Location 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Auricular Nerve Stimulation for Chronic Pain
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ear stimulation (Location 1) Other: Stimulation at Location 1
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).

Experimental: Ear stimulation (Location 2) Other: Stimulation at Location 2
Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).




Primary Outcome Measures :
  1. Low Back Pain Intensity [ Time Frame: 4 months ]
    This is a uni-dimensional measure of pain intensity. It uses an 11-point numeric scale. We will use it to measure the patient's average pain intensity in the past week, which will be measured at the beginning and end of the study.


Secondary Outcome Measures :
  1. Roland-Morris Disability Questionnaire score [ Time Frame: 4 months ]
    The modified RMDQ is a self-administered disability measure in cLBP patients.

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) scores [ Time Frame: 4 months ]
    The PROMIS, funded by the NIH, is a system containing reliable, flexible, precise, and responsive assessment tools that have been widely validated in numerous samples. We will use PROMIS-29 to assess pain interferences and intensity, physical function, depression, anxiety, fatigue, and sleep in the past 7 days.

  3. Pain medication dose changes [ Time Frame: 4 months ]
    Pain medication dose changes as determined by a weekly-collected medication log

  4. Pain Catastrophizing Scale [ Time Frame: 4 months ]
    The PCS is a 15-item questionnaire used to characterize an individual's tendency to magnify the threat value of a pain experience and to feel helpless in the presence of pain.

  5. The Pennebaker Inventory of Limbic Languidness [ Time Frame: 4 months ]
    PILL allows individuals to rate how frequently they have experienced each of 54 common symptoms over an unspecified time period in the past using a five-point Likert scale. The PILL contains a range of physical symptoms, including some items that are pain-related (e.g., headache, back pains, sore muscles).


Other Outcome Measures:
  1. Resting state functional connectivity changes of the PAG [ Time Frame: 1 month ]
    Functional connectivity changes of the periaqueductal gray while at rest.

  2. Resting state functional connectivity of the medial and lateral hypothalamus [ Time Frame: 1 month ]
    Functional connectivity changes of the hypothalamus while at rest.

  3. CBF as measured by ASL [ Time Frame: 1 month ]
    Changes in cerebral blood flow.

  4. Inflammation biomarkers [ Time Frame: 1 month ]
    Changes in inflammatory biomarker levels



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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Volunteers 21-60 years of age.
  • Meet the Classification Criteria of chronic LBP (having low back pain for more than 6 months), as determined by a referring physician.
  • Received stable treatment or no treatment in the past month.
  • At least a 10th grade English-reading level. English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.

Exclusion Criteria:

  • Specific causes of back pain (e.g., epidural abscess, compression fracture, spondyloarthropathy, malignancy, cauda equina syndrome) or radicular pain, radiculopathy, or spinal canal stenosis. Complicated back problems (e.g., prior back surgery, medico-legal issues).
  • Presence of headache/migraine, as well as widespread body pain such as fibromyalgia.
  • The intent to undergo surgery during participation in the study.
  • History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcomes (e.g., asthma or claustrophobia).
  • Presence of any contraindications to MRI scanning (e.g., cardiac pacemaker, metal implants, fear of enclosed spaces, pregnancy, cannot lie still in fMRI scanner).
  • Conditions that might confound longitudinal effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis).
  • Pregnant or lactating.
  • Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1).
  • Active substance abuse disorders within the last 24 months (based on subject self-report).
  • Use of prescription steroids for pain during the past six months.
  • Presence of any other acute or chronic pain disorder.
  • Any medical conditions, such as peripheral neuropathy, that could affect the results of QST.

Information from the National Library of Medicine

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): NCT03959111


Contacts
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Contact: Jian Kong 617-726-7893 JKONG2@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jian Kong Massachusetts General Hospital

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Responsible Party: Jian Kong, Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03959111     History of Changes
Other Study ID Numbers: 2016P000678
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms