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Auricular Acupuncture 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 : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date August 15, 2019
Estimated Study Start Date  ICMJE September 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03959111 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
  • Roland-Morris Disability Questionnaire score [ Time Frame: 4 months ]
    The modified RMDQ is a self-administered disability measure in cLBP patients.
  • 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.
  • Pain medication dose changes [ Time Frame: 4 months ]
    Pain medication dose changes as determined by a weekly-collected medication log
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 20, 2019)
  • Resting state functional connectivity changes of the PAG [ Time Frame: 1 month ]
    Functional connectivity changes of the periaqueductal gray while at rest.
  • Resting state functional connectivity of the medial and lateral hypothalamus [ Time Frame: 1 month ]
    Functional connectivity changes of the hypothalamus while at rest.
  • CBF as measured by ASL [ Time Frame: 1 month ]
    Changes in cerebral blood flow.
  • Inflammation biomarkers [ Time Frame: 1 month ]
    Changes in inflammatory biomarker levels
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Auricular Acupuncture Stimulation for Chronic Pain
Official Title  ICMJE Auricular Acupuncture Stimulation for Chronic Pain
Brief Summary This proposal aims to investigate the treatment effect and underlying mechanism of transcutaneous acupuncture 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Low Back Pain
Intervention  ICMJE
  • 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).
  • 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).
Study Arms  ICMJE
  • Experimental: Ear stimulation (Location 1)
    Intervention: Other: Stimulation at Location 1
  • Experimental: Ear stimulation (Location 2)
    Intervention: Other: Stimulation at Location 2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
70
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Volunteers 18-65 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jian Kong 617-726-7893 JKONG2@mgh.harvard.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959111
Other Study ID Numbers  ICMJE 2016P000678
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian Kong, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Kong Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP