Comparisons between the efficacy of limaprost alfadex and pregabalin in cervical spondylotic radiculopathy : design of a randomized controlled trial

Abstract

Background : Cervical spondylotic radiculopathy (CSR) is a relatively common neurological disease caused by the mechanical compression of nerve roots. Limaprost, a prostaglandin E 1 derivative, functions as a vasodilator and has been used in the treatment of lumbar spinal stenosis in Japan. However, the effects of limaprost in cervical radiculopathy remain unclear. Our aim was to compare the efficacy of limaprost with that of pregabalin, which is widely used for the treatment of neuropathic pain. Methods : In this randomized trial, patients with CSR received either limaprost or pregabalin orally for 8 weeks, along with nonsteroidal anti -inflammatory drugs. The primary outcomes were assessed using a numerical rating scale of pain and numbness, both at rest and during movement. Secondary outcomes were assessed using Short Form -36, provocation tests, painDETECT questionnaire, and subjective global assessment. The obtained data were evaluated according to the per -protocol analysis principle. Results : A total of 46 patients were enrolled in this study, and 35 were available for analysis. A greater reduction in pain score was observed in neck pain during movement, and scapular and arm pain both at rest and during movement in the pregabalin -treated group up to 4 weeks. In the limaprost -treated group, numbness of the arm during movement showed a marked alleviation compared to the pregabalin -treated group at 8 weeks. There were no apparent differences between the two groups in terms of the secondary outcomes. Conclusions : Although pregabalin provided an earlier pain relief than limaprost, limaprost was superior to pregabalin in treating arm numbness. Limaprost might be one of the effective therapeutic options for CSR in primary care settings.

Eligibility Criteria of Participants in Randomized Controlled Trials Assessing Conservative Management of Cervical Radiculopathy: A Systematic Review

“…Of the 68 studies, 54 included at least two categories (clinical symptoms, clinical examination tests, and/or imaging),13–73 with 12 studies including participants based on clinical symptoms alone74–85 and two including participants based on clinical examination findings alone 86,87. Twenty-six trials required clinical symptoms in addition to positive clinical examination tests,17–19,25,27,29,30,33,42,43,45–47,51,52,54,56,59,60,62,63,65,67,68,70–72,88 six trials required clinical symptoms in addition to imaging,14,15,24,35,41,53,61,73 two required physical examination findings in addition to imaging,39,48 and 20 required clinical symptoms in addition to positive clinical examination tests and imaging 13,16,20–23,28,31,32,34,36–38,40,44,49,50,55,57,58,64,66,69…”

“…Of the 68 distinct trials, 22 included a description of participants suffering from a specific etiology (disk herniation and/or cervical spondylosis) 13–16,20–25,28,34,35,38–40,44,48–50,53,61,64,69,76,77,79,85. In the 22 trials, there was a relatively equal split between which etiology was included and assessed in the study.…”

“…Of the 68 distinct trials, 28 included some form of diagnostic imaging, with MRI being the most commonly used in 11 trials. [13][14][15][16]24,28,32,40,41,44,55,57,69 The remaining trials required a combination of x-ray, 36,64 CT and/or MRI, 39,49,50,58,61 EMG, 66 MRI and EMG, 35,48 x-ray and MRI, 34,53,73 x-ray, MRI or CT, [20][21][22][23]37 and two had no specific mention of the test used. 31,38…”

Yunmen (LU 2) combined with neck-seven-acupoint acupuncture for arm numbness caused by cervical spondylotic radiculopathy

“…CSR is a disease that involves ischemia of compressed cervical nerve roots. [ 7 ] It is widely known that conservative therapies can relieve CSR symptoms, although pharmacotherapy as a part of a multimodal and initial approach can play a clinical role with its effect not being all that ideal. [ 8 , 9 ] Traditional Chinese medicine interventions have been widely used for the management of CSR, and acupuncture, as a non-invasive treatment, is one of the most popular because many clinicians have reported their experiences of its effects on the radicular syndrome, such as pain and paresthesia.…”

Thunder-fire moxibustion for cervical spondylotic radiculopathy: Study protocol for a randomized controlled trial

“…In practice, analgesics are standard primary treatments for CSR unless there is evidence of spinal cord disease or apparent inability to move. Nonsteroidal antiinflammatory drugs (NSAIDs) could relieve pain as firstline agents in acute settings [7]. The efficacy of ibuprofen in the treatment of cervical nerve root pain has also been reported [8], but it can only relieve pain and has no effect on the other symptoms of CSR.…”