Brain Imaging of Lidoderm for Chronic Back Pain
Completed · Phase 4 · Has a placebo group
Conditions studied: Low Back Pain
In brief
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.
Key facts
- Study ID
- NCT01515540
- Run by
- Northwestern University
- People needed
- 38
- Starts
- 2004-01-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2013-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Northwestern University — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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