Adults 18 to 65, any sex, with Low Back Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Low Back Pain IntensityPrimary· 1 month
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.
The Roland-Morris Disability Questionnaire (RMDQ) is a widely used self-reported measure of physical disability specifically designed for individuals with low back pain. The questionnaire assesses the impact of back pain on daily activities. The total score ranges from 0 to 24, where: 0 indicates no disability, 24 indicates severe disability.
Group
Value
95% CI
Ear Stimulation (Area With VN)
2.3
± 4.1
Ear Stimulation (Area Without VN)
1.7
± 3.9
Patient-Reported Outcomes Measurement Information System (PROMIS) ScoresSecondary· baseline and post-treatment
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. 29 items covering seven domains and one additional question about pain intensity. Here we focus on Pain Interference (4 items, raw score range 4-20, T-score range roughly 41-76, mean and SD in chronic pain patients is 67.1 and 5.79. The 67.1indicates the population mean in chronic pain patients with a standard deviation of 5.79 based on publication PMCID: PMC8412832). Higher T-scores = more pain interference. We compared pre- an
Group
Value
95% CI
Ear Stimulation (Area With VN)
3.5
± 6.0
Ear Stimulation (Area Without VN)
4.4
± 4.9
The Pennebaker Inventory of Limbic LanguidnessSecondary· Baseline
The Pennebaker Inventory of Limbic Languidness (PILL) is a self-report questionnaire assessing the frequency of common physical symptoms. Participants rate how often they have experienced each symptom over a specified retrospective period using a 5-point Likert scale. The PILL includes a broad range of symptoms, including pain-related items (e.g., headache, back pain, sore muscles). The PILL was administered at baseline only to characterize baseline symptom sensitivity/awareness and to reduce participant burden. Total scores are computed as the sum of 53 items rated from 1-5 (total score range
Group
Value
95% CI
Ear Stimulation (Area With VN)
103.2
± 32.1
Ear Stimulation (Area Without VN)
98.9
± 28.0
Resting State Functional Connectivity Changes of the PAGSecondary· 1 month
Resting state functional connectivity refers to the statistical relationship between the time-series activity of different brain regions as measured by functional MRI (fMRI). Functional connectivity changes of the periaqueductal gray (PAG) at rest refer to alterations in the neural communication between the PAG and other brain regions when a subject is not actively engaged in a task. The PAG, located in the midbrain, plays a critical role in pain modulation, defensive behavior, and autonomic regulation.
Group
Value
95% CI
Ear Stimulation (Area With VN)
0.1
± 0.1
Ear Stimulation (Area Without VN)
-0.1
± 0.1
Resting State Functional Connectivity of the Medial and Lateral HypothalamusSecondary· 1 month
Resting state functional connectivity refers to the statistical relationship between the time-series activity of different brain regions as measured by functional MRI (fMRI). Functional connectivity changes of the medial and lateral hypothalamus at rest refer to alterations in the neural communication between the two regions and other brain regions when a subject is not actively engaged in a task.
Group
Value
95% CI
Ear Stimulation (Area With VN)
0.1
± 0.1
Ear Stimulation (Area Without VN)
-0.03
± 0.1
CBF as Measured by ASLSecondary· 1 month
Changes in cerebral blood flow were evaluated by comparing pre-to-post change between the real and sham groups. Statistically significant clusters identified in this comparison are reported in the Results Data Tables, including a cluster located in the precentral gyrus.
Group
Value
95% CI
Ear Stimulation (Location 1)
-8.4
± 15.87
Ear Stimulation (Location 2)
2.87
± 14.46
Inflammation BiomarkersSecondary· 1 month
Changes in inflammatory biomarker levels of PD1 between baseline and week 4
Group
Value
95% CI
Ear Stimulation (Area With VN)
.01
± 44.99
Ear Stimulation (Area Without VN)
4.76
± 41.33
Adverse events — posted to ClinicalTrials.gov
Time frame: Over the 4-week intervention.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07526012 — Comparative Effects Of Post Isometric Relaxation Versus Active Isolated Stretch In Patients With Piriformis Syndrome
· NA
· recruiting
NCT07535047 — Placebo-Induced Hypoalgesia During Transcutaneous Electrical Nerve Stimulation Application in Low Back Pain
· NA
· recruiting
NCT07463729 — Evaluation of Stabilization Training With Biofeedback in Lumbosacral Spine Pain Syndrome
· NA
· recruiting
NCT07250568 — Office Program Effects on Pain, Posture, Muscle Physiology, Stress, Ergonomics, and Quality of Life in LBP Workers
· NA
· recruiting
NCT07467070 — Effectiveness of Pilates on Postural Correction, Core Strength and Flexibility in Younger Individuals With Non-specific
· NA
· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Massachusetts General Hospital
Last refreshed: 11 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03959111.