Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
NCT ID: NCT03046017
Last Updated: 2023-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2017-08-30
2023-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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real tDCS
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Control cream
A neutral cream will be applied as a control.
sham 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.
tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Control cream
A neutral cream will be applied as a control.
control group
In this group, participants will receive tDCS but will only receive a cream on their lower back.
tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Control cream
A neutral cream will be applied as a control.
Interventions
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tDCS
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Lidocaine cream
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Control cream
A neutral cream will be applied as a control.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
21 Years
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Jian Kong
Associate Professor
Locations
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Martinos Center for Biomedical Imagin
Charlestown, Massachusetts, United States
Countries
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Central Contacts
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Other Identifiers
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2015P001440
Identifier Type: -
Identifier Source: org_study_id
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