Auricular Acupuncture Stimulation for Chronic Pain

Study Overview
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Brief Summary
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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.

Official Title
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Auricular Acupuncture Stimulation for Chronic Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Stimulation at Location 1
* Other: Stimulation at Location 2


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ear stimulation (Location 1)<br> | Other: Stimulation at Location 1<br>* 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).<br>|
| Experimental: Ear stimulation (Location 2)<br> | Other: Stimulation at Location 2<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland-Morris Disability Questionnaire score | The modified RMDQ is a self-administered disability measure in cLBP patients. | 4 months | 
| 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. | 4 months | 
| Pain medication dose changes | Pain medication dose changes as determined by a weekly-collected medication log | 4 months | 
| 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. | 4 months | 
| 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). | 4 months |