Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Not Applicable
Recruiting
- Conditions
- Chronic Low Back Pain
- Interventions
- Device: tDCSOther: Lidocaine creamOther: Control cream
- Registration Number
- NCT03046017
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
Chronic low back pain patients aged 21 to 60 needed for a research study of the effects of transcranial direct current stimulation (tDCS) on the analgesic effects of lidocaine cream as measured by functional Magnetic Resonance Imaging (fMRI). Study will be conducted on nine separate days not requiring an overnight stay in the hospital.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- Volunteers 21-60 years of age.
- Meets the Classification Criteria of chronic LBP (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 LBP VAS (criteria recommended by Dworkin et al.)
- 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 outcome. For example: asthma, claustrophobia, epilepsy or acute eczema under the electrodes.
- Presence of any contraindications to MRI scanning. For example: cardiac pacemaker, metal implants, claustrophobia, pregnancy, cannot lie still in an fMRI scanner.
- History of medical or psychiatric illness.
- History of substance / alcohol abuse or dependence.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description real tDCS Lidocaine cream In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity. real tDCS Control cream In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity. sham tDCS Control cream In this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. control group Control cream In this group, participants will receive tDCS but will only receive a cream on their lower back. sham tDCS tDCS In this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. real tDCS tDCS In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity. sham tDCS Lidocaine cream In this group, sham tDCS does not provide real stimulation though participants will not know this until the debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. control group tDCS In this group, participants will receive tDCS but will only receive a cream on their lower back. control group Lidocaine cream In this group, participants will receive tDCS but will only receive a cream on their lower back.
- Primary Outcome Measures
Name Time Method fMRI signal changes 2 days; Sessions 5 and 7 Gracely Scale pain rating changes 2 days; Sessions 2 and 7 resting state functional connectivity changes 2 days; Sessions 5 and 7
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Martinos Center for Biomedical Imagin
🇺🇸Charlestown, Massachusetts, United States