NCT03959111

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 17, 2019

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4.5 years

First QC Date

May 20, 2019

Results QC Date

August 11, 2024

Last Update Submit

February 19, 2026

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Low Back Pain Intensity

    This is a uni-dimensional measure of chronic low back pain intensity. It uses an 11-point numeric scale (0 indicate no pain, and 10 indicates max level of pain that can be imagined). 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.

    1 month

Secondary Outcomes (5)

  • Roland-Morris Disability Questionnaire Score

    1 months

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Scores

    baseline and post-treatment

  • Pain Catastrophizing Scale

    baseline and post-treatment

  • The Pennebaker Inventory of Limbic Languidness

    Baseline

  • Resting State Functional Connectivity Changes of the PAG

    1 month

Other Outcomes (3)

  • Resting State Functional Connectivity of the Medial and Lateral Hypothalamus

    1 month

  • CBF as Measured by ASL

    1 month

  • Inflammation Biomarkers

    1 month

Study Arms (2)

Ear stimulation (Location 1)

EXPERIMENTAL
Other: Stimulation at Location 1

Ear stimulation (Location 2)

EXPERIMENTAL
Other: Stimulation at Location 2

Interventions

Stimulation at Location 1OTHER

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).

Ear stimulation (Location 1)
Stimulation at Location 2OTHER

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).

Ear stimulation (Location 2)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (1)

  • Li Y, Li T, Yan K, Wu J, Reddy S, Sacca V, Ursitti AK, Zhu M, Hodges S, Chen L, Kong J. Both Transcutaneous Auricular Vagus Nerve Stimulation and Great Auricular Nerve Stimulation Modulate Functional and Structural Connectivity of Brainstem Nuclei in Chronic Low Back Pain. Neuromodulation. 2025 Oct 15:S1094-7159(25)01025-6. doi: 10.1016/j.neurom.2025.08.415. Online ahead of print.

    PMID: 41091086DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Prof. Jian Kong
Organization
MGH
jkong2@mgh.harvard.edu
6179620978

Study Officials

  • Jian Kong

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

October 17, 2019

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 11, 2026

Results First Posted

March 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)