Brain Imaging of Lidoderm for Chronic Back Pain
CompletedPhase 4NCT01515540
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Brain Imaging of Lidoderm for Chronic Back Pain
- Conditions
- Interventions
- Sponsor
- Northwestern University
- Collaborators
- Endo USA Inc., a Keenova Therapeutics Company
- Start date
- 2004-01
- Primary completion
- 2010-06
- Sex
- All
- Age range
- from 18 Years
- Healthy volunteers
- true
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01515540