A Phase 4 interventional study of lidocaine and placebo in Low Back Pain, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-07-30.
Sponsored by Northwestern University · Phase 4, Interventional, and Basic science
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.
Previous data showed that Lidoderm patches that contain 5% Lidocaine applied to the affected area for a period of 1-2 weeks decreased chronic pain. We conducted a preliminary open-label trial in chronic back pain patients and found that the patients reported reduction in pain intensity and associated brain activity (measured with fMRI). As a next step, we conducted a double blind clinical trial where the drug was tested against placebo to determine whether the effects on CBP were mediated by a pharmacological mechanism. For this we obtained psychophysical measurements of pain and measures of brain activity using fMRI. Two scans after treatment (6 hour and 2 weeks after treatment) were conducted to observe the effects of short term and long term use.
Brain activity was measured by the non-invasive method of functional imaging (fMRI), which enables examination of cortical blood flow during pain rating. These brain scans were acquired in chronic back pain patients while they rated their ongoing chronic pain using a finger span device. In a control task, each patient also rated the changes in the length of a bar n a screen (a visual control task). Anatomical scans were also acquired.
The general design of the study was that CBP subjects were assesses with fmri for brain responses for ongoing pain at three time points. The initial (baseline) scan occurred after a minimum of 48 hour period during which the patients refrained from taking analgesic medication. The patients were next scanned at 6 hours after treatment and again after 2 weeks of continuous treatment. Subjects were randomised to placebo or Lidoderm (both Lidoderm and placebo patches were supplied by Endo Pharmaceuticals).
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 38 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
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Exclusion Criteria:
5% lidoderm patch
Drug: lidocaine
placebo patch
Drug: placebo
5% lidoderm patch
Also known as: Lidoderm (Endo Pharmaceuticals), 5% lidocaine patch
placebo
Also known as: sham patch
Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable".
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.
Time frame: 2 weeks
38 patients were recruited for the brain imaging and treatment study. Data from 7 subjects was not analyzed due to failure to attend the repeat sessions for non specific reasons and data from 1 subject was excluded from analysis due to technical faults. Thus, data from a total of 30 subjects was included in the brain imaging analysis.
| Milestone | Lidocaine | Control |
|---|---|---|
| Started | 20 | 18 |
| Completed | 15 | 15 |
| Not completed | 5 | 3 |
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.
| peak pain intensity | Lidocaine | Control |
|---|---|---|
| Pain Intensity on a Visual Analog Scale (VAS) The Scale Had Values From 0-100, Where 0 Represents "no Pain" and 100 Was the "Worst Pain Imaginable". | 51.0 ± 7.6 | 51.6 ± 7.1 |
Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lidocaine | — | 0/20 (0%) | 0/20 (0%) |
| Control | — | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | Lidocaine | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 18 | 38 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Lidocaine | Control | Total |
|---|---|---|---|
| Mean | 53 ± 7.7 | 49.73 ± 10.27 | 51.36 ± 9.1 |
| Sex: Female, Male(Participants) | Lidocaine | Control | Total |
|---|---|---|---|
| Female | 8 | 9 | 17 |
| Male | 12 | 9 | 21 |
| Region of Enrollment(participants) | Lidocaine | Control | Total |
|---|---|---|---|
| United States | 20 | 18 | 38 |
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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