Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    120
  • sponsor
    Massachusetts General Hospital
Updated on 28 March 2021

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.

Details
Condition Pain, Post-Surgical Pain, Pain (Pediatric), Pain, Chronic Pain, Chronic Pain, Post-Surgical Pain, Pain (Pediatric), chronic pains
Treatment Sham acupuncture, Sham tDCS, Real tDCS, Verum acupuncture
Clinical Study IdentifierNCT03716830
SponsorMassachusetts General Hospital
Last Modified on28 March 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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