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

Published version
Peer-reviewed

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Authors

Davies, Benjamin 
Mowforth, Oliver D 
Alvarez-Berdugo, Daniel 
Bond, Simon 

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.

Description

Peer reviewed: True


Acknowledgements: Research in the senior author’s laboratory is supported by the Cambridge NIHR Brain Injury MedTech Cooperative. MRNK is supported by a NIHR Clinician Scientist Award.

Keywords

neurosurgery, spine, Adult, Humans, Spinal Cord Diseases, Neck, Adjuvants, Immunologic, Bone Marrow Diseases, Pain, Randomized Controlled Trials as Topic, Multicenter Studies as Topic

Journal Title

BMJ Open

Conference Name

Journal ISSN

2044-6055
2044-6055

Volume Title

Publisher

BMJ
Sponsorship
Department of Health (via National Institute for Health Research (NIHR)) (CS-2015-15-023)