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

Abstract

BackgroundPain 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.MethodsPatients 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.ResultsWe 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.ConclusionPregabalin 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.

<p>Effectiveness of pregabalin for treatment of chronic cervical radiculopathy with upper limb radiating pain: an 8-week, multicenter prospective observational study in Japanese primary care settings</p>

“…In the present observational study of Japanese patients with chronic refractory cervical pain with a NeP component, significant improvements in self-reported sleep interference and pain scores were reported after 8 weeks of treatment with pregabalin (with or without other analgesics) compared with “usual care” with conventional analgesic therapy. In addition to supporting evidence for pregabalin improving aspects of sleep, the data presented here support the efficacy of pregabalin in other patients with neck pain,29–31,39 and in Japanese patients with different types of NeP, based on clinical trial data,21,22,40 as well as non-interventional24 and long-term open-label studies for postherpetic neuralgia, diabetic peripheral neuropathy26,41 and central NeP 27. The reductions in PRSIS (–1.17) and pain NRS (–2.26) in the current study were similar to those reported previously in a similarly designed study of Japanese patients treated with pregabalin for chronic lower back pain associated with NeP 24.…”

“…One study of acute sciatica in Australian patients suggests pregabalin is not effective at reducing acute pain,45 nor in other types of lumbar radial pain 46. Whereas other studies have demonstrated the efficacy of pregabalin, in combination with other agents, in NeP associated with nerve compression,31,39 including one small study of chronic sciatica in Australian patients 46. These observations collectively highlight the complexity of NeP, and the need for more high-quality studies to confirm the efficacy of specific drug combinations in different patient populations.…”

Efficacy of Pregabalin in the Treatment of Radicular Pain: Results of a Controlled Trial

“…The efficacy of pregabalin has been demonstrated in multiple randomized, controlled trials for a number of neuropathic pain conditions such as post-herpetic neuralgia ( 16 , 17 ), diabetic neuropathy ( 18 , 19 ), fibromyalgia ( 20 ), and spinal cord injury pain ( 15 ). We encountered two previous studies of pregabalin use in patients with RP ( 21 , 22 ). While one such trial reported inconclusive results ( 21 ), the other reported the efficacy of pregabalin in patients with cervical radiculopathy ( 22 ).…”

“…We encountered two previous studies of pregabalin use in patients with RP ( 21 , 22 ). While one such trial reported inconclusive results ( 21 ), the other reported the efficacy of pregabalin in patients with cervical radiculopathy ( 22 ). The latter trial, however, cited significant study limitations and recommended further evaluation of pregabalin in patients with RP by a well-designed study.…”

Effectiveness of posterior percutaneous full-endoscopic cervical foraminotomy for cervical osseous foraminal stenosis

“…In 2017, Ye et al [10]. observed the clinical efficacy of percutaneous full-endoscopic cervical foraminotomy in the treatment of bony stenosis of the intervertebral foramen, indicating that it is a safe and feasible surgical approach [11]. This study aimed to evaluate and measure the effect of decompression, as well as evaluate the clinical efficacy of percutaneous full-endoscopic cervical foraminotomy in the treatment of bony stenosis of the cervical nerve root canal.…”