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control group for Chronic Lower Back Pain
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 days; sessions 5 and 7
Awards & highlights
Study Summary
This trial will study the effects of tDCS on chronic low back pain, using fMRI to measure the analgesic effects of lidocaine cream.
Eligible Conditions
- Chronic Lower Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 days; sessions 5 and 7
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 days; sessions 5 and 7
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Gracely Scale pain rating changes
fMRI signal changes
resting state functional connectivity changes
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: control groupExperimental Treatment3 Interventions
In this group, participants will receive tDCS but will only receive a cream on their lower back.
Group II: real tDCSActive Control3 Interventions
In this group, the tDCS stimulates areas of the brain being examined in this study to increase their activity.
Group III: sham tDCSPlacebo Group3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tDCS
2017
Completed Phase 2
~640
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,878 Total Patients Enrolled
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