. 2023 Mar 7;13(3):e061294.

doi: 10.1136/bmjopen-2022-061294.

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol

Benjamin Davies¹, Oliver D Mowforth¹, Stefan Yordanov¹, Daniel Alvarez-Berdugo², Simon Bond², Marianna Nodale², Paula Kareclas², Lynne Whitehead³, Jon Bishop⁴, Siddharthan Chandran⁵, Sarah Lamb⁶, Mark Bacon⁷, Marios C Papadopoulos⁸, Michelle Starkey⁹, Iwan Sadler⁹, Lara Smith⁹, Sukhvinder Kalsi-Ryan¹⁰, Adrian Carpenter¹¹, Rikin A Trivedi¹, Martin Wilby¹², David Choi¹³, Ian B Wilkinson², Michael G Fehlings¹⁴, Peter John Hutchinson¹, Mark R N Kotter¹⁵

Affiliations

¹ Department of Neurosurgery, Cambridge University, Cambridge, UK.
² Cambridge Clinical Trials Unit, Cambridge University Hospital, Cambridge, UK.
³ Pharmacy Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁴ Medical Statistician, NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK.
⁵ Edinburgh Medical School & Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
⁶ Institute of Health Research, University of Exeter, Exeter, UK.
⁷ International Spinal Research Trust, London, UK.
⁸ Department of Neurosurgery, St George's Hospital, London, UK.
⁹ Myelopathy.org, Cambridge, UK.
¹⁰ Toronto Rehabilitation Institute, Toronto, Ontario, Canada.
¹¹ Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
¹² Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
¹³ Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK.
¹⁴ Department of Surgery, Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.
¹⁵ Department of Neurosurgery, Cambridge University, Cambridge, UK Mrk25@medschl.cam.ac.uk.

PMID: 36882259
PMCID: PMC10008337
DOI: 10.1136/bmjopen-2022-061294

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol

Benjamin Davies et al. BMJ Open. 2023.

. 2023 Mar 7;13(3):e061294.

doi: 10.1136/bmjopen-2022-061294.

Authors

Affiliations

¹ Department of Neurosurgery, Cambridge University, Cambridge, UK.
² Cambridge Clinical Trials Unit, Cambridge University Hospital, Cambridge, UK.
³ Pharmacy Department, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
⁴ Medical Statistician, NIHR Surgical Reconstruction and Microbiology Research Centre, Birmingham, UK.
⁵ Edinburgh Medical School & Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.
⁶ Institute of Health Research, University of Exeter, Exeter, UK.
⁷ International Spinal Research Trust, London, UK.
⁸ Department of Neurosurgery, St George's Hospital, London, UK.
⁹ Myelopathy.org, Cambridge, UK.
¹⁰ Toronto Rehabilitation Institute, Toronto, Ontario, Canada.
¹¹ Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.
¹² Department of Neurosurgery, The Walton Centre NHS Foundation Trust, Liverpool, UK.
¹³ Department of Neurosurgery, National Hospital for Neurology and Neurosurgery, London, UK.
¹⁴ Department of Surgery, Toronto Western Hospital and University of Toronto, Toronto, Ontario, Canada.
¹⁵ Department of Neurosurgery, Cambridge University, Cambridge, UK Mrk25@medschl.cam.ac.uk.

PMID: 36882259
PMCID: PMC10008337
DOI: 10.1136/bmjopen-2022-061294

Abstract

Introduction: Degenerative cervical myelopathy (DCM) is a common and disabling condition of symptomatic cervical spinal cord compression secondary to degenerative changes in spinal structures leading to a mechanical stress injury of the spinal cord. RECEDE-Myelopathy aims to test the disease-modulating activity of the phosphodiesterase 3/phosphodiesterase 4 inhibitor Ibudilast as an adjuvant to surgical decompression in DCM.

Methods and analysis: RECEDE-Myelopathy is a multicentre, double-blind, randomised, placebo-controlled trial. Participants will be randomised to receive either 60-100 mg Ibudilast or placebo starting within 10 weeks prior to surgery and continuing for 24 weeks after surgery for a maximum of 34 weeks. Adults with DCM, who have a modified Japanese Orthopaedic Association (mJOA) score 8-14 inclusive and are scheduled for their first decompressive surgery are eligible for inclusion. The coprimary endpoints are pain measured on a visual analogue scale and physical function measured by the mJOA score at 6 months after surgery. Clinical assessments will be undertaken preoperatively, postoperatively and 3, 6 and 12 months after surgery. We hypothesise that adjuvant therapy with Ibudilast leads to a meaningful and additional improvement in either pain or function, as compared with standard routine care.

Study design: Clinical trial protocol V.2.2 October 2020.

Ethics and dissemination: Ethical approval has been obtained from HRA-Wales.The results will be presented at an international and national scientific conferences and in a peer-reviewed journals.

Trial registration number: ISRCTN Number: ISRCTN16682024.

Keywords: neurosurgery; spine.

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Conflict of interest statement

Competing interests: MRNK holds a research grant from clinical scientist award and has support for the study from Medicinova. MCP holds research grant award with the NIHR. BD holds research grants with NIHR HTA POLYFIX-DCM, Evelyn Trust (DCM-COINs) and award from National Lottary UK for developing a peer-to-peer support community for Degenerative Cervical myelopathy. BD is also a founder of MoveMed Ltd. PJH holds NIHR research grants.

Figures

**Figure 1**
Trial flow chart. Eligible and consenting participants will be randomised to an intervention or control arm and followed up for 12 months after surgery. DCM, degenerative cervical myelopathy; IMP, investigational medicinal product.

See this image and copyright information in PMC

References

1. Davies BM, Mowforth OD, Smith EK, et al. . Degenerative cervical myelopathy. BMJ 2018;360:k186. 10.1136/bmj.k186 - DOI - PMC - PubMed
1. Kadanka Z, Adamova B, Kerkovsky M, et al. . Predictors of symptomatic myelopathy in degenerative cervical spinal cord compression. Brain Behav 2017;7:e00797. 10.1002/brb3.797 - DOI - PMC - PubMed
1. Kovalova I, Kerkovsky M, Kadanka Z, et al. . Prevalence and imaging characteristics of Nonmyelopathic and myelopathic spondylotic cervical cord compression. Spine 2016;41:1908–16. 10.1097/BRS.0000000000001842 - DOI - PubMed
1. Smith SS, Stewart ME, Davies BM, et al. . The prevalence of asymptomatic and symptomatic spinal cord compression on magnetic resonance imaging: a systematic review and meta-analysis. Global Spine J 2021;11:597–607. 10.1177/2192568220934496 - DOI - PMC - PubMed
1. Akter F, Kotter M. Pathobiology of degenerative cervical myelopathy. Neurosurg Clin N Am 2018;29:13–19. 10.1016/j.nec.2017.09.015 - DOI - PubMed

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Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol

Affiliations

Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol

Authors

Affiliations

Abstract

Conflict of interest statement

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Medical