Abstract
BackgroundRadiculopathy due to lumbar or cervical disc disease is the most common chronic neuropathic pain in adults. The aim of present study was evaluation of low dose of sodium valproate (VPA) on radicular pain and determining VPA pharmacokinetics.Materials and MethodsIn this double blind randomized placebo control clinical study, 80 patients with established lumbar or cervical radicular pain, have been randomly allocated into two study groups: 40 have received sodium valproate 200 mg/day and Celecoxib 100 mg/day and acetaminophen 500 mg PRN as rescue medication, and second group has received placebo, Celecoxib and acetaminophen. Quantitative assessment of pain was done by visual analogue scale (VAS) prior to perform the intervention and after ten days (treatment duration). Blood sample has been taken for determining mean through concentration after five half-lives. Evaluation of plasma concentration of VPA and that of efficacy on pain score relationship by comparing VAS before and after the therapy was done.ResultsGroup A and B have demonstrated significant alleviation in mean VAS score; −21.97 ± 25.41, −14.39 ± 23.03 respectively (P < 0.001). The mean plasma concentration of VPA in group A was: 26.9 ± 13.5 mg/L. Moreover, no significant correlation was seen between pain score with age, gender, and weight (p > 0.05).ConclusionLow dose of sodium valproate especially together with NSAIDs demonstrated good efficacy in lumbar and cervical radicular pain management.
Highlights
Radicular pain is the main manifestation of radiculopathy that lancinating and traveling on a narrow band which it maybe repetitive episode or paroxysmal
The present double-blind randomized placebocontrolled study was conducted in 80 patients (35 male, 45 female) who have suffered from cervical and or lumbar radicular pain (Fig. 1). 20-70 years old subjects without any certain medical complication such as gestation, heart failure, liver and or kidney disease had been enrolled for the trial, likewise patients who have taken non-steroidal anti-inflammatory drugs, anti-convulsants for radicular pain relief or other medical reasons and any drugs which had had direct or indirect impress on patients subjective pain insight (SSRI or TCA and other antidepressants) were excluded or if it was possible the patients were asked to stop drugs at least one week before study
All patients were randomly divided into 2 groups, randomization was done by the use of random numbers table, treatment plan of group A comprised of sodium valproate 200 mg/day, Celecoxib 200 mg/day and acetaminophen 500 mg PRN, group B or control group's treatment plan contained placebo once a day, Celecoxib 200 mg/day and acetaminophen 500 mg PRN, duration of treatment was ten days, all patients were emphasized that Valproate must be administered on 12 AM before meal and Celecoxib must be administered at night after dinner, except for treatment with sodium valproate, target therapy groups and control group were similar in all respects
Summary
Radicular pain is the main manifestation of radiculopathy that lancinating and traveling on a narrow band which it maybe repetitive episode or paroxysmal. Cervical and lumbar radicular pain is often correlated with neurologic symptoms comprise of numbness, lacks of sensitivity reflexes and motor weakness called radiculopathy [4]. Lumbar radicular pain owing to damaged disc is at least 20 times more common than other neuropathic pains with 4.5% prevalence in adults older than 30 years old, there are no analgesic dose-control trials in this disease [5]. Radiculopathy due to lumbar or cervical disc disease is the most common chronic neuropathic pain in adults. The aim of present study was evaluation of low dose of sodium valproate (VPA) on radicular pain and determining VPA pharmacokinetics
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