Back to resultsNeuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Primary Purpose
Chronic Low Back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Lidocaine cream
Control cream
Sponsored by
About this trial
This is an interventional basic science trial for Chronic Low Back Pain
Eligibility Criteria
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.
Sites / Locations
- Martinos Center for Biomedical ImaginRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Sham Comparator
Other
Arm Label
real tDCS
sham tDCS
control group
Arm Description
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
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.
In this group, participants will receive tDCS but will only receive a cream on their lower back.
Outcomes
Primary Outcome Measures
fMRI signal changes
Gracely Scale pain rating changes
resting state functional connectivity changes
Secondary Outcome Measures
Full Information
NCT ID
NCT03046017
First Posted
January 27, 2017
Last Updated
December 29, 2022
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03046017
Brief Title
Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Official Title
Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2017 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real tDCS
Arm Type
Active Comparator
Arm Description
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
In this group, participants will receive tDCS but will only receive a cream on their lower back.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
Intervention Type
Other
Intervention Name(s)
Lidocaine cream
Intervention Description
Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
Intervention Type
Other
Intervention Name(s)
Control cream
Intervention Description
A neutral cream will be applied as a control.
Primary Outcome Measure Information:
Title
fMRI signal changes
Time Frame
2 days; Sessions 5 and 7
Title
Gracely Scale pain rating changes
Time Frame
2 days; Sessions 2 and 7
Title
resting state functional connectivity changes
Time Frame
2 days; Sessions 5 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Georgia Wilson, BA
Phone
617-726-5004
Email
gjwilson@mgh.harvard.edu
Facility Information:
Facility Name
Martinos Center for Biomedical Imagin
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
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Neuromodulation of Lidocaine Cream Effect on Chronic Pain Patients
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