Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
NCT03716830 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2025-11-05
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.
Conditions
Interventions
- DEVICE
-
verum acupuncture
Participants will receive real acupuncture treatment.
- DEVICE
-
sham acupuncture
Participants will receive sham acupuncture treatment.
- DEVICE
-
real tDCS
Participants will receive real transcranial direct current stimulation.
- DEVICE
-
sham tDCS
Participants will receive sham transcranial direct current stimulation.
Sponsors & Collaborators
-
Massachusetts General Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-07
- Primary Completion
- 2025-01-31
- Completion
- 2025-03-31
Countries
- United States
Study Locations
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