Brain Imaging of Lidoderm for Chronic Back Pain
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: lidocaine 5% lidoderm patch |
Drug: lidocaine
5% lidoderm patch
Other Names:
|
| Placebo Comparator: control placebo patch |
Drug: placebo
placebo
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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". [2 weeks]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or Female 18 years or older of age
-
Pain in the location of the lower back
-
Pain duration for a minimum of 6 months on a continuous basis
-
Pain intensity of at least 3 out of 10 on most days of the week over the past six months
-
Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).
-
Right handedness
Exclusion Criteria:
-
Applying for or currently receiving workers' compensation or disability status.
-
Back pain secondary to spinal cord injury
-
Back pain secondary to any systemic condition (e.g ankylosing spondylitis0
-
Diabetes mellitus
-
Back pain secondary to tumors.
-
Standard MRI criteria re: claustrophobia, metal objects etc.
-
Subjects with cognitive deficits such as dementia, psychiatric illness including depression with a BDI score of more than 19 (moderate to severe depression), history of brain injury, history of chronic disease
-
Pregnant and/or lactating women
-
Left handedness
-
Active cancer
-
Other serious painful condition (e.g., arthritis)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Northwestern University | Chicago | Illinois | United States | 60611 |
Sponsors and Collaborators
- Northwestern University
- Endo Pharmaceuticals
Investigators
- Principal Investigator: Apkar V. Apkarian, PhD, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- STU00022968
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Lidocaine | Control |
|---|---|---|
| Arm/Group Description | 5% lidoderm patch | placebo patch |
| Period Title: Overall Study | ||
| STARTED | 20 | 18 |
| COMPLETED | 15 | 15 |
| NOT COMPLETED | 5 | 3 |
Baseline Characteristics
| Arm/Group Title | Lidocaine | Control | Total |
|---|---|---|---|
| Arm/Group Description | 5% lidoderm patch | placebo patch | Total of all reporting groups |
| Overall Participants | 20 | 18 | 38 |
| Age (Count of Participants) | |||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
100%
|
18
100%
|
38
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
53
(7.7)
|
49.73
(10.27)
|
51.36
(9.1)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
8
40%
|
9
50%
|
17
44.7%
|
| Male |
12
60%
|
9
50%
|
21
55.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
20
100%
|
18
100%
|
38
100%
|
Outcome Measures
| Title | 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". |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| based on a literature search. |
| Arm/Group Title | Lidocaine | Control |
|---|---|---|
| Arm/Group Description | 5% lidoderm patch | placebo patch |
| Measure Participants | 15 | 15 |
| Mean (Standard Deviation) [peak pain intensity] |
51.0
(7.6)
|
51.6
(7.1)
|
Adverse Events
| Time Frame | 2 weeks | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Lidocaine | Control | ||
| Arm/Group Description | 5% lidoderm patch | placebo patch | ||
All Cause Mortality |
||||
| Lidocaine | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Lidocaine | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/18 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Lidocaine | Control | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/20 (0%) | 0/18 (0%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Javeria Ali Hashmi |
|---|---|
| Organization | Northwestern University |
| Phone | 3125037991 |
| j-hashmi@northwestern.edu |
- STU00022968