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01-06-2016 | Original Article

Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial

Authors: S. Rajasekaran, Siddharth N. Aiyer, Ajoy Prasad Shetty, Rishi Mugesh Kanna, Anupama Maheswaran, Janardhan Yerram Shetty

Published in: European Spine Journal | Issue 6/2016

Abstract

Purpose

To evaluate the effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy using clinical parameters and DTI analysis.

Methods

Early cervical myelopathy cases with MJOA scores ≥13, were recruited for the double-blinded, placebo-controlled randomised control trial. Thirty cases with fifteen cases each in the test and placebo group were studied. Analysis was done using diffusion tensor imaging (DTI) and clinical evaluation, pre- and post-institution of sodium channel blocker Riluzole for a period of 1 month (50 mg twice daily). Placebo group was treated with Vitamin B complex tablets. Diffusion co-efficient fractional anisotrophy (FA), apparent diffusion co-efficient (ADC), volume ratio (VR), relative anisotrophy (RA) and Eigen vectors were calculated. Outcomes analysis was based on clinical scores of MJOA, Nurick grading, SF-12, NDI, and statistical analysis of DTI datametrics.

Results

The mean MJOA score was 15.6 (13–17) with no significant change in the test and control groups. The mean ADC, FA values were 1533.36 (1238–1779) and 494.36 (364–628) and changed to 1531.57 (1312–2091) and 484.86 (294–597), respectively, in the Riluzole group. However, the changes in the values of ADC, FA, and other co-efficients including VR, RA and eigenvectors in the two groups were not statistically significant. The functional scores in the SF-12 and NDI questionnaires did not change significantly.

Conclusions

Our study did not show a significant change in the clinical outcome and DTI Indices with the use of Riluzole as a standalone pharmacotherapeutic agent for early cervical myelopathy. More studies may be needed to confirm the usefulness of Riluzole as a treatment option for cervical myelopathy.

Rao RD, Currier BL, Albert TJ, Bono CM, Marawar SV, Poelstra KA, Eck JC (2007) Degenerative cervical spondylosis: clinical syndromes, pathogenesis, and management. J Bone Joint Surg 89(6):1360–1378PubMed

Shedid D, Benzel EC (2007) Cervical spondylosis anatomy: pathophysiology and biomechanics. Neurosurgery 60(1):S1–S7CrossRef

Bernhardt M, Hynes RA, Blume HW, White AA (1993) Cervical spondylotic myelopathy. J Bone Joint Surg 75(1):119–128PubMed

Rao R (2002) Neck pain, cervical radiculopathy, and cervical myelopathy. J Bone Joint Surg 84(10):1872–1881PubMed

Kadanka Z, Mareš M, Bednarík J, Smrcka V, Krbec M, Stejskal L, Dušek L (2002) Approaches to spondylotic cervical myelopathy: conservative versus surgical results in a 3-year follow-up study. Spine 27(20):2205–2210CrossRefPubMed

Kadaňka Z, Bednařík J, Novotný O, Urbánek I, Dušek L (2011) Cervical spondylotic myelopathy: conservative versus surgical treatment after 10 years. Eur Spine J 20(9):1533–1538CrossRefPubMedPubMedCentral

Sampath P, Bendebba M, Davis JD, Ducker TB (2000) Outcome of patients treated for cervical myelopathy: a prospective, multicenter study with independent clinical review. Spine 25(6):670–676CrossRefPubMed

Yoshimatsu H, Nagata K, Goto H, Sonoda K, Ando N, Imoto H, Takamiya Y (2001) Conservative treatment for cervical spondylotic myelopathy: prediction of treatment effects by multivariate analysis. Spine J 1(4):269–273CrossRefPubMed

Schwartz G, Fehlings MG (2001) Evaluation of the neuroprotective effects of sodium channel blockers after spinal cord injury: improved behavioral and neuroanatomical recovery with riluzole. J Neurosurg Spine 94(2):245–256CrossRef

10.

Thomsen C, Henriksen O, Ring P (1987) In vivo measurement of water self diffusion in the human brain by magnetic resonance imaging. Acta Radiol Diagn (Sweden) 28(3):353–361CrossRef

11.

Hoehn-berlar M, Eis M, Back T, Kohno K, Yamashita K (1995) Changes of relaxation times (T1, T2) and apparent diffusion coefficient after permanent middle cerebral artery occlusion in the rat: temporal evolution, regional extent, and comparison with histology. Magn Reson Med 34(6):824–834CrossRef

12.

Rajasekaran S, Kanna RM, Shetty AP (2012) Diffusion tensor imaging of the spinal cord and its clinical applications. J Bone Joint Surg Br 94(8):1024–1031CrossRefPubMed

13.

LaRocca H (1988) Cervical spondylotic myelopathy: natural history. Spine 13(7):854–855CrossRefPubMed

14.

Clarke E, Robinson PK (1956) Cervical myelopathy: a complication of cervical spondylosis. Brain 79(3):483–510CrossRefPubMed

15.

Lees F, Turner JA (1963) Natural history and prognosis of cervical spondylosis. Br Med J 2(5373):1607CrossRefPubMedPubMedCentral

16.

Nurick S (1972) The natural history and the results of surgical treatment of the spinal cord disorder associated with cervical spondylosis. Brain 95(1):101–108CrossRefPubMed

17.

Symon L, Lavender P (1967) The surgical treatment of cervical spondylotic myelopathy. Neurology 17(2):117CrossRefPubMed

18.

Phillips DG (1973) Surgical treatment of myelopathy with cervical spondylosis. J Neurol Neurosurg Psychiatry 36(5):879–884CrossRefPubMedPubMedCentral

19.

Katoh S, Ikata T, Hirai N, Okada Y, Nakauchi K (1995) Influence of minor trauma to the neck on the neurological outcome in patients with ossification of the posterior longitudinal ligament (OPLL) of the cervical spine. Spinal Cord 33(6):330–333CrossRef

20.

Bednařík J, Sládková D, Kadaňka Z, Dušek L, Keřkovský M, Voháňka S, Němec M (2011) Are subjects with spondylotic cervical cord encroachment at increased risk of cervical spinal cord injury after minor trauma? J Neurol Neurosurg Psychiatry 82(7):779–781CrossRefPubMed

21.

Rhee JM, Shamji MF, Erwin WM, Bransford RJ, Yoon ST, Smith JS, Kalsi-Ryan S (2013) Nonoperative management of cervical myelopathy: a systematic review. Spine 38(22S):S55–S67CrossRefPubMed

22.

Ducreux D, Lepeintre JF, Fillard P, Loureiro C, Tadie M, Lasjaunias P (2006) MR diffusion tensor imaging and fiber tracking in 5 spinal cord astrocytomas. Am J Neuroradiol 27(1):214–216PubMed

23.

Demir A, Ries M, Moonen CT, Vital JM, Dehais J, Arne P, Dousset V (2003) Diffusion-weighted MR imaging with apparent diffusion coefficient and apparent diffusion tensor maps in cervical spondylotic myelopathy 1. Radiology 229(1):37–43CrossRefPubMed

24.

Mamata H, Jolesz FA, Maier SE (2005) Apparent diffusion coefficient and fractional anisotropy in spinal cord: age and cervical spondylosis-related changes. J Magn Reson Imaging 22(1):38–43CrossRefPubMed

25.

Avadhani A, Ilayaraja V, Shetty AP, Rajasekaran S (2010) Diffusion tensor imaging in horizontal gaze palsy with progressive scoliosis. Magn Reson Imaging 28(2):212–216CrossRefPubMed

26.

Rajasekaran S, Kanna RM, Karunanithi R, Shetty AP (2010) Diffusion tensor tractography demonstration of partially injured spinal cord tracts in a patient with posttraumatic Brown Sequard syndrome. J Magn Reson Imaging 32(4):978–981CrossRefPubMed

27.

Miller RG, Mitchell JD, Lyon M, Moore DH (2007). Riluzole for amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND). Cochrane Database Syst Rev (1). doi:10.1002/14651858

28.

Grossman RG, Toups EG, Frankowski RF, Burau KD, Howley S (2012) North American clinical trials network for the treatment of spinal cord injury: goals and progress. J Neurosurg Spine 17(1):6–10CrossRefPubMed

29.

Fehlings MG, Wilson JR, Karadimas SK, Arnold PM, Kopjar B (2013) Clinical evaluation of a neuroprotective drug in patients with cervical spondylotic myelopathy undergoing surgical treatment: design and rationale for the CSM-protect trial. Spine 38(22S):S68–S75CrossRefPubMed

30.

Schwartz G, Fehlings MG (2002) Secondary injury mechanisms of spinal cord trauma: a novel therapeutic approach for the management of secondary pathophysiology with the sodium channel blocker riluzole. Prog Brain Res 137:177–190CrossRefPubMed

31.

Karadimas SK, Gatzounis G, Fehlings MG (2014) Pathobiology of cervical spondylotic myelopathy. Eur Spine J 24(2):132–138PubMed

Title: Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial
Authors: S. Rajasekaran
Siddharth N. Aiyer
Ajoy Prasad Shetty
Rishi Mugesh Kanna
Anupama Maheswaran
Janardhan Yerram Shetty
Publication date: 01-06-2016
Publisher: Springer Berlin Heidelberg
Published in: European Spine Journal / Issue 6/2016
Print ISSN: 0940-6719
Electronic ISSN: 1432-0932
DOI: https://doi.org/10.1007/s00586-015-4323-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial

Abstract

Purpose

Methods

Results

Conclusions

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusions

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