Clinical trial NCT03716830: Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Official title: Enhancing Acupuncture Treatment Effect Through Non-invasive Neuromodulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomized to one of four groups: 1) verum acupuncture + real tDCS, 2) sham acupuncture + real tDCS, 3) verum acupuncture + sham tDCS, and 4) sham acupuncture + sham tDCS.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Periaqueductal Gray (PAG) Resting State Functional Connectivity (rsFC) Changes
timeFrame: Day 1 (pre-intervention); post-intervention at Week 4
Secondary outcomes:
measure: Clinical Outcomes as Measured by LBP Intensity Scores
timeFrame: Day 1 (pre-intervention); post-intervention at Week 4
measure: Cerebral Blood Flow (CBF) Differences Before and After Treatments
timeFrame: Day 1 (pre-intervention); post-intervention at Week 4
measure: Quantitative Sensory Testing (QST) Differences
timeFrame: Day 1 (pre-intervention); post-intervention at Week 4
measure: Differences in rsFC of M1 and Other Networks
timeFrame: Day 1 (pre-intervention); post-intervention at Week 4
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: