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NCT01515540 · ClinicalTrials.gov registry record · Phase 4
Brain Imaging of Lidoderm for Chronic Back Pain
A Phase 4 study of Low Back Pain, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01515540: Completed Phase 4 study of Low Back Pain, sponsored by Northwestern University.
NCT01515540 is a Phase 4 study of Low Back Pain that has completed, run by Northwestern University. The registered enrollment target is 38 participants, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01515540, a Phase 4 study of Low Back Pain, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators tested whether pain decrease can be observed centrally with non-invasive brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of 5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of Lidocaine versus Placebo patches. Three time points were evaluated: baseline (before treatment) and 6 hours and 2 weeks after treatment. The latter trial was a 2 arm, double blind, placebo controlled trial, where participants either received Lidoderm or placebo patches, without cross over.
Primary Outcome
the primary hypothesis was that the lidoderm 5% patch was expected to decrease pain intensity post treatment greater than placebo patch. A lower value on the 0-100 scale is considered to represent less pain. Higher values represent more pain. Greater than 20%-30% decrease in pain is considered clinically meaningful.
Conditions Studied
Interventions
- DRUG placebo
- DRUG lidocaine
Study Locations (1)
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2004-01 |
| Est. Completion | 2010-06 |
| Phase | Phase 4 |
What the finished NCT01515540 record still lists
NCT01515540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 503-participant average among 122 other Low Back Pain trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT01515540 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01515540 about?
NCT01515540 is a clinical study titled "Brain Imaging of Lidoderm for Chronic Back Pain". The investigators tested whether pain decrease can be observed centrally with non-invasive brain imaging in CBP subjects receiving Lidoderm. The investigators first tested effects of 5% Lidoderm patched in an open labelled trial. Next the investigators compared the effects of Lidocaine versus Placeb...
What is the current status of trial NCT01515540?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2004-01. Estimated completion is 2010-06.
What conditions does trial NCT01515540 study?
This clinical trial studies the following conditions: Low Back Pain.
What interventions are being tested in trial NCT01515540?
The interventions under investigation include: placebo (DRUG), lidocaine (DRUG).
Who is sponsoring clinical trial NCT01515540?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01515540 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Low Back Pain
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01515540's enrollment target sits among peer trials
38 102nd of 122 higher than 20 of 122 other Low Back Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Low Back Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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