At a glance
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Corticostriatal Plasticity in the Transition to Chronic Pain: Effect of L-dopa
In Brief
A Phase 4 clinical trial evaluating Naproxen, Carbidopa/Levodopa, and 1 other intervention for Sub-acute Back Pain. Completed, enrolled 72 participants across 1 site.
Detailed Summary
This study aims to determine if early treatment with Carbidopa/Levodopa and Naproxen in individuals with sub-acute back pain (SBP) is associated with changes in blocking transition to chronic back pain (CBP).
Study Details
Timeline
Interventions
Take one 250mg naproxen tablet three times a day for 12 weeks.
12.5mg/50mg Carbidopa/Levodopa, administered orally as capsules, will be titrated up to TID over one week and then continued at that level for 4 weeks. If at the end of this initial 4 week period the participant has "responded," the subject will be maintained on that dose for the duration of the treatment period (12 weeks total). If there has not been a response, the dose will be increased to 25mg/100mg Carbidopa/Levodopa TID for the following 4 weeks at which time the pain status will be re-evaluated. If a response has occurred, that dose will be maintained in a blinded manner for the following 4 weeks of treatment; if not, further dose-titration will occur to 50mg/200mg Carbidopa/Levodopa TID for the final 4 weeks. If a subject experiences an AE at higher doses, then the subject will be given the next lower dose that s/he was able to tolerate and then be maintained on that dose for the remainder of the 12 week dosing period.
Take two placebo capsules three times a day for 12 weeks.