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Auricular Acupuncture Stimulation for Chronic Pain

Primary Purpose

Low Back Pain

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulation at Location 1
Stimulation at Location 2
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ear stimulation (Location 1)

Ear stimulation (Location 2)

Arm Description

Outcomes

Primary Outcome Measures

Low Back Pain Intensity
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

Roland-Morris Disability Questionnaire score
The modified RMDQ is a self-administered disability measure in cLBP patients.
Patient-Reported Outcomes Measurement Information System (PROMIS) scores
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
Pain medication dose changes as determined by a weekly-collected medication log
Pain Catastrophizing Scale
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
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).

Full Information

First Posted
May 20, 2019
Last Updated
March 7, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03959111
Brief Title
Auricular Acupuncture Stimulation for Chronic Pain
Official Title
Auricular Acupuncture Stimulation for Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ear stimulation (Location 1)
Arm Type
Experimental
Arm Title
Ear stimulation (Location 2)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Stimulation at Location 1
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Stimulation at Location 2
Intervention Description
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 Measure Information:
Title
Low Back Pain Intensity
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Roland-Morris Disability Questionnaire score
Description
The modified RMDQ is a self-administered disability measure in cLBP patients.
Time Frame
4 months
Title
Patient-Reported Outcomes Measurement Information System (PROMIS) scores
Description
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.
Time Frame
4 months
Title
Pain medication dose changes
Description
Pain medication dose changes as determined by a weekly-collected medication log
Time Frame
4 months
Title
Pain Catastrophizing Scale
Description
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.
Time Frame
4 months
Title
The Pennebaker Inventory of Limbic Languidness
Description
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).
Time Frame
4 months
Other Pre-specified Outcome Measures:
Title
Resting state functional connectivity changes of the PAG
Description
Functional connectivity changes of the periaqueductal gray while at rest.
Time Frame
1 month
Title
Resting state functional connectivity of the medial and lateral hypothalamus
Description
Functional connectivity changes of the hypothalamus while at rest.
Time Frame
1 month
Title
CBF as measured by ASL
Description
Changes in cerebral blood flow.
Time Frame
1 month
Title
Inflammation biomarkers
Description
Changes in inflammatory biomarker levels
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Kong
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Auricular Acupuncture Stimulation for Chronic Pain

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