Neuropathic Pain Caused by Lumbar Radicular Pain Clinical Trial
Official title:
Effect of Minocycline on Neuropathic Pain
The purpose of this study is to determine if minocycline is effective in the treatment of neuropathic pain. The effect of minocycline will be compared to the effect of placebo and amitriptyline.
Neuropathic pain is pain caused by damage to the central or peripheral nervous system. To
date, therapy consists of tricyclic antidepressants (such as amitriptyline) or
anticonvulsants. However, results are disappointing. Minocycline, a FDA-approved second
generation tetracycline, was efficacious in various animal models of neuropathic pain. We
want to study the effect of minocycline in neuropathic pain in humans. The type of
neuropathic pain we want to investigate is lumbar radicular pain since this is the most
prevalent condition associated with neuropathic pain in humans.
This placebo-controlled randomized double blind trial consists of 3 arms:
1. Placebo, once daily by mouth during 14 days.
2. Amitriptyline 25mg, once daily by mouth during 14 days.
3. Minocycline 100mg, once daily by mouth during 14 days.
Patients can take rescue medication if necessary: tramadol 50mg by mouths up to 3-times
daily.
Brain-derived neurotrophic factor is implicated in the generation and maintenance of
neuropathic pain in different animal models of neuropathic pain. To study the role of
brain-derived neurotrophic factor in neuropathic pain in humans, we will determine its
concentration in serum and plasma before and after 14 days medication intake.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment