Low Back Pain
Conditions
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.
Interventions
OTHERStimulation 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).
OTHERStimulation 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).
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Low Back Pain Intensity | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire Score | 1 months | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Scores | 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- and post-treatment difference of the pain interference subscore. |
| Pain Catastrophizing Scale | baseline and post-treatment | The Pain Catastrophizing Scale (PCS) is a 15-item questionnaire assessing the extent to which individuals magnify the threat of pain and feel helpless in the presence of pain. Due to an administration error, the full 15-item PCS was not collected as intended: participants received an incomplete version of the questionnaire (missing items), which prevents calculation of valid total and subscale scores. This error occurred during data collection and affected all attempted administrations (including both planned time points, where applicable); therefore, no participants have analyzable PCS data to report for this outcome measure. |
| The Pennebaker Inventory of Limbic Languidness | 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: 53-265), with higher scores indicating more frequent symptoms (worse outcome) and lower scores indicating less frequent symptoms (better outcome). |
| Resting State Functional Connectivity Changes of the PAG | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJian Kong
Massachusetts General Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 40.8 year STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 45 Participants |
| Region of Enrollment United States | 34 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 0 / 34 |
| other Total, other adverse events | 4 / 36 | 3 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
None listed