Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
CompletedNot applicableNCT03716830
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
- Conditions
- Interventions
- Device: verum acupuncture
- Device: sham acupuncture
- Device: real tDCS
- Device: sham tDCS
- Sponsor
- Massachusetts General Hospital
- Start date
- 2020-11-07
- Primary completion
- 2025-01-31
- Sex
- All
- Age range
- from 18 Years to 60 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03716830