Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Study Overview
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Brief Summary
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In this study, investigators will examine the brain mechanism behind the synergistic effects of combining acupuncture and transcranial direct current stimulation (tDCS) treatments. Specifically, chronic low back pain (cLBP) patients will be recruited and randomized to one of four groups (30 per group, one month of treatment): 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS. Investigators will study 1) the longitudinal (one-month) effects of different treatments as indicated by changes in resting state functional connectivity (rsFC), cerebral blood flow (CBF), clinical outcomes of low back pain, and quantitative sensory test (QST) and 2) the association between these changes.

Official Title
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Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: verum acupuncture
* Device: sham acupuncture
* Device: real tDCS
* Device: sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: volunteers 18-60 years of age meet the classification criteria of chronic low back pain (having low back pain for more than 6 months), as determined by the referring physician at least 4/10 clinical pain on the 11-point Low Back Pain Numeric Rating Scale (LBP NRS) at least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures Exclusion Criteria: history of epilepsy or loss consciousness (LOC) specific causes of back pain (e.g. cancer, fractures, spinal stenosis, infections) complicated back problems (e.g. prior back surgery, medicolegal issues) the intent to undergo surgery during the time of involvement 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. For example: asthma or claustrophobia presence of any contraindications to magnetic resonance imaging (MRI) scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, inability to remain still in MRI scanner history of medical or psychiatric illness as determined by the investigator history of substance abuse or dependence

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Factorial Assignment
Interventional Model Description: Participants will be randomized to one of four groups: 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: verum acupuncture + real tDCS<br> | Device: verum acupuncture<br>* Participants will receive real acupuncture treatment.<br>Device: real tDCS<br>* Participants will receive real transcranial direct current stimulation.<br>|
| Experimental: sham acupuncture + real tDCS<br> | Device: sham acupuncture<br>* Participants will receive sham acupuncture treatment.<br>Device: real tDCS<br>* Participants will receive real transcranial direct current stimulation.<br>|
| Experimental: verum acupuncture + sham tDCS<br> | Device: verum acupuncture<br>* Participants will receive real acupuncture treatment.<br>Device: sham tDCS<br>* Participants will receive sham transcranial direct current stimulation.<br>|
| Sham Comparator: sham acupuncture + sham tDCS<br> | Device: sham acupuncture<br>* Participants will receive sham acupuncture treatment.<br>Device: sham tDCS<br>* Participants will receive sham transcranial direct current stimulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes | Investigators will explore whether tDCS and acupuncture treatments evoke PAG rsFC connectivity changes. This outcome will be assessed by comparing participants' pre-treatment MRI scans to their post-treatment scans. | Day 1 (pre-intervention); post-intervention at Week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes as Measured by LBP Intensity Scores | The Low Back Pain Numeric Rating Scale (LBP NRS) will be used to assess clinical outcomes. Participants will be required to rate their pain on this scale prior to the first treatment and after all treatments. | Day 1 (pre-intervention); post-intervention at Week 4 | 
| Cerebral Blood Flow (CBF) Differences Before and After Treatments | Investigators will examine CBF changes before and after treatment in several pain-related brain areas. CBF data will be collected during arterial spin labeling (ASL) scans that will take place before the first treatment and after the last treatment. Images from these scans will be aggregated to an average CBF-weighted image to be used for analysis. | Day 1 (pre-intervention); post-intervention at Week 4 | 
| Quantitative Sensory Testing (QST) Differences | Participants' QST ratings will be analyzed before and after all treatments. | Day 1 (pre-intervention); post-intervention at Week 4 | 
| Differences in rsFC of M1 and Other Networks | Similar to the CBF measure, rSFC will be analyzed from ASL data (obtained during MRI scanning). rSFC from pre- to post-treatment will be compared. | Day 1 (pre-intervention); post-intervention at Week 4 |