Status:
COMPLETED
Brain Imaging of Lidoderm for Chronic Back Pain
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Endo Pharmaceuticals
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 patch...
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 chron...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01515540
Start Date
January 1 2004
End Date
June 1 2010
Last Update
July 30 2013
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611