Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
NCT ID: NCT03716830
Last Updated: 2025-11-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
116 participants
INTERVENTIONAL
2020-11-07
2025-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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verum acupuncture + real tDCS
verum acupuncture
Participants will receive real acupuncture treatment.
real tDCS
Participants will receive real transcranial direct current stimulation.
sham acupuncture + real tDCS
sham acupuncture
Participants will receive sham acupuncture treatment.
real tDCS
Participants will receive real transcranial direct current stimulation.
verum acupuncture + sham tDCS
verum acupuncture
Participants will receive real acupuncture treatment.
sham tDCS
Participants will receive sham transcranial direct current stimulation.
sham acupuncture + sham tDCS
sham acupuncture
Participants will receive sham acupuncture treatment.
sham tDCS
Participants will receive sham transcranial direct current stimulation.
Interventions
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verum acupuncture
Participants will receive real acupuncture treatment.
sham acupuncture
Participants will receive sham acupuncture treatment.
real tDCS
Participants will receive real transcranial direct current stimulation.
sham tDCS
Participants will receive sham transcranial direct current stimulation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Jian Kong
Associate Professor, Associate Researcher
Locations
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Massachusetts General Hospital
Charlestown, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2018P001970
Identifier Type: -
Identifier Source: org_study_id
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