Phase 4
N=38
Brain Imaging of Lidoderm for Chronic Back Pain
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01515540 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Jul 2013
Primary outcome: Primary: 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; 51.6 peak pain intensity
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- lidocaine (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 51.6 | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT01515540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.