Pregabalin and Radicular Pain Study (PARPS) for Cervical Spondylosis in a Multiracial Asian Population.

Background: Pain from cervical spondylosis (CS) may result from degenerative spinal canal stenosis (cervical spondylotic myelopathy (CSM)) or lateral recesses compromise, leading to nerve root compression (cervical spondylotic radiculopathy (CSR)). Pregabalin was shown to be effective in randomized, placebo-controlled trials for post-herpetic neuralgia and diabetic neuropathy. We evaluate its efficacy in CS with underlying CSR or CSM in a prospective study comprising Asian patients for the first time.

Methods: Patients with CS and CSR or CSM (clinical, MRI, or electrophysiological evidence) presenting with neuropathic pain were recruited. We excluded patients with diabetes, underlying neurological disease or who were previously on antiepileptics. Pregabalin 75 mg bd was administered for 4 weeks, after which dosage was increased to 150 mg bd for another 4 weeks if the visual analog scale (VAS) was not reduced by 50%. In addition, we monitored the short form McGill pain questionnaire (SFMPQ) at baseline, 4 weeks and 8 weeks. Mood changes were monitored using the hospital anxiety and depression score (HADS) with an identical timeline.

Results: We recruited 50 patients, of which 23 completed the trial. Of the 27 who withdrew, 12 (44%) were for somnolence. Thirteen patients' (54%) dosages remained at 75 mg and 11 patients' (46%) dosages were escalated to 150 mg bd. There were significantly reducing trends from baseline for VAS (ANOVA, F(1, 21) = 25.4, P < 0.0005), SFMPQ (sensory) (F(1, 22) = 11.2, P = 0.003), and SFMPQ (affective) (F(1, 21) = 10.9, P = 0.008). For VAS, there was significant reduction at 4 weeks (P = 0.001) and 8 weeks (P < 0.0005) compared to baseline. For SFMPQ (sensory), there was significant reduction at 4 weeks (P = 0.01) and 8 weeks (P = 0.006) in scores compared to baselines. For SFMPQ (affective), there was significant reduction at 4 weeks (P = 0.04) and 8 weeks (P = 0.008) in scores compared to baseline. No significant anxiety (F(1, 4) = 1.3, P = 0.32) or depression (F(1, 4) = 0.06, P = 0.82) changes were observed in the HADS.

Conclusion: Pregabalin is efficacious in alleviation of pain symptoms related to CSR as a first-line single agent, evaluated by quantitative severity and other experiential scales. No significant mood changes reported in other studies were demonstrated. Somnolence was commonest adverse effect leading to high dropout rates, occurring early even at the lowest dose. The findings suggest the need for further studies of efficacy at lower dosages, particularly in the Asian population.