Brain Imaging of Lidoderm for Chronic Back Pain

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Northwestern University
• Collaborator: Endo Pharmaceuticals
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

1. Male or Female 18 years or older of age

2. Pain in the location of the lower back

3. Pain duration for a minimum of 6 months on a continuous basis

4. Pain intensity of at least 3 out of 10 on most days of the week over the past six months

5. Manifestations of radicular element of pain: radiation below knee (examples towards thigh, buttocks).

6. Right handedness

Exclusion Criteria:

1. Applying for or currently receiving workers' compensation or disability status.

2. Back pain secondary to spinal cord injury

3. Back pain secondary to any systemic condition (e.g ankylosing spondylitis0

4. Diabetes mellitus

5. Back pain secondary to tumors.

6. Standard MRI criteria re: claustrophobia, metal objects etc.

7. 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

8. Pregnant and/or lactating women

9. Left handedness

10. Active cancer

11. Other serious painful condition (e.g., arthritis)