Chronic Low-back Pain
Conditions
Brief summary
Investigating the modulation effect of tACS
Detailed description
Investigating the modulation effect of one-month Transcranial alternating current stimulation (tACS) for low back pain
Interventions
Sponsors
Massachusetts General Hospital
National Institute of Neurological Disorders and Stroke (NINDS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Volunteers 18-60 years of age 2. Meet the Classification Criteria of the chronic LBP (having low back pain for more than 6 months) 3. At least 4/10 clinical pain on the 0-10 LBP NRS 4. 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 5. Meeting the MRI / MEG / EEG screening criteria
Exclusion criteria
1. Specific causes of back pain (eg, cancer, fractures, spinal stenosis, infections) 2. Complicated back problems (eg, prior back surgery, medicolegal issues) 3. The intent to undergo surgery during the time of involvement in the study 4. 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 outcome (for example: asthma or claustrophobia) 5. Presence of any contraindications to MRI scanning (for example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in fMRI scanner) 6. Concomitant autoimmune, chronic, inflammatory, neoplastic, and psychiatric diseases 7. Pregnant or lactating 8. Conditions making study participation difficult (e.g., paralysis, psychoses, or other severe psychological problems as per the judgment of a study investigator during Session 1) 9. Active substance abuse disorders (based on subject self-report and drug test) 10. Regular use of pain medication such as opioids, nonopioid analgesics, coanalgesics, corticosteroids, or immunomodulatory agents 11. Any medical conditions, such as peripheral neuropathy, that could affect the results of QST 12. Current use of psychotropic medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha activity at rest | Baseline and week 4 | EEG/MEG data will be collected to measure alpha activity. |
| TC resting state functional connectivity | Baseline and week 4 | fMRI data will be collected to measure resting state functional connectivity. |
| Numeric Rating Scale (NRS) for pain intensity | Baseline and week 4 | The NRS is a uni-dimensional measure of pain intensity that uses an 11-point numeric scale. We will use it to measure the average low back pain intensity in the past week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alpha activity during tonic pressure pain | Baseline and week 4 | EEG/MEG data will be collected during administration of tonic pressure pain to measure alpha activity changes before and after tACS. |
| TC functional connectivity during tonic pain | Baseline and week 4 | fMRI data will be collected during administration of tonic pressure pain to measure functional connectivity changes before and after tACS. |
Countries
United States
Contacts
CONTACTJIAN KONG
Outcome results
None listed