N/A
N=70
Auricular Vagus Nerve Stimulation for Chronic Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT03959111 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Low Back Pain Intensity — 1.24; 1.73 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stimulation at Location 1 (Other); Stimulation at Location 2 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Low Back Pain Intensity |
1.24; 1.73 | — |
| SECONDARY Roland-Morris Disability Questionnaire Score |
2.3; 1.7 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS) Scores |
3.5; 4.4 | — |
| SECONDARY Pain Catastrophizing Scale |
— | — |
| SECONDARY The Pennebaker Inventory of Limbic Languidness |
103.2; 98.9 | — |
| SECONDARY Resting State Functional Connectivity Changes of the PAG |
0.1; -0.1 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03959111). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.