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

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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.

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Authors and Affiliations

  1. Department of Spine Surgery, Ganga Hospital, 313, Mettupalayam Road, Coimbatore, 641043, India

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

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  1. S. Rajasekaran
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  2. Siddharth N. Aiyer
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  3. Ajoy Prasad Shetty
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  4. Rishi Mugesh Kanna
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  5. Anupama Maheswaran
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  6. Janardhan Yerram Shetty
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Corresponding author

Correspondence to S. Rajasekaran.

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Funding

The project was funded jointly by Ganga Orthopaedic Research & Education Foundation, Coimbatore and AO spine Asia Pacific.

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical approval

The study has been approved by the Institutional research ethics committee and has been performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

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Rajasekaran, S., Aiyer, S.N., Shetty, A.P. et al. Effectiveness of Riluzole as a pharmacotherapeutic treatment option for early cervical myelopathy: a double-blinded, placebo-controlled randomised controlled trial. Eur Spine J 25, 1830–1835 (2016). https://doi.org/10.1007/s00586-015-4323-1

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  • DOI: https://doi.org/10.1007/s00586-015-4323-1

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