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

Benjamin Davies, Oliver D Mowforth, Stefan Yordanov, Daniel Alvarez-Berdugo, Simon Bond, Marianna Nodale, Paula Kareclas, Lynne Whitehead, Jon Bishop, Siddharthan Chandran, Sarah Lamb, Mark Bacon, Marios C Papadopoulos, Michelle Starkey, Iwan Sadler, Lara Smith, Sukhvinder Kalsi-Ryan, Adrian Carpenter, Rikin A Trivedi, Martin WilbyDavid Choi, Ian B Wilkinson, Michael G Fehlings, Peter John Hutchinson, Mark R N Kotter

Research output: Contribution to journalArticlepeer-review

Abstract / Description of output

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.


Original languageEnglish
Article numbere061294
Pages (from-to)e061294
JournalBMJ Open
Issue number3
Publication statusPublished - 7 Mar 2023

Keywords / Materials (for Non-textual outputs)

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


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