N/A
Completed N=116
Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Source: ClinicalTrials.gov NCT03716830 ↗Enrolled (actual)
116
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes — -0.03; 0.02; 0.11; -0.03 Fisher z-transformed correlation coeffic
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes |
-0.03; 0.02; 0.11; -0.03 | — |
| SECONDARY Clinical Outcomes as Measured by LBP Intensity Scores |
-1.39; -1.08; -1.45; -1.59 | — |
| SECONDARY Cerebral Blood Flow (CBF) Differences Before and After Treatments |
3.3; -2.8; 2.7; 3.9 | — |
| SECONDARY Quantitative Sensory Testing (QST) Differences |
-0.2; 1.0; -1; -0.6 | — |
| SECONDARY Primary Motor Cortex (M1) rsFC Changes Before and After 4-week Treatments |
0.14; -0.01; -0.03; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03716830). 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. Informational only — not medical advice.