Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

Mass General Brigham

Status: Completed

Conditions: Chronic Pain

Treatments: Device: sham acupuncture; Device: verum acupuncture; Device: sham tDCS; Device: real tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT03716830

2018P001970

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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116 participants in 4 patient groups

verum acupuncture + real tDCS

Experimental group

Treatment:

Device: real tDCS

Device: verum acupuncture

sham acupuncture + real tDCS

Experimental group

Treatment:

Device: real tDCS

Device: sham acupuncture

verum acupuncture + sham tDCS

Experimental group

Treatment:

Device: sham tDCS

Device: verum acupuncture

sham acupuncture + sham tDCS

Sham Comparator group

Treatment:

Device: sham tDCS

Device: sham acupuncture