Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol.
neurosurgery
spine
Journal
BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874
Informations de publication
Date de publication:
07 03 2023
07 03 2023
Historique:
entrez:
7
3
2023
pubmed:
8
3
2023
medline:
10
3
2023
Statut:
epublish
Résumé
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. 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. Clinical trial protocol V.2.2 October 2020. 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. ISRCTN Number: ISRCTN16682024.
Identifiants
pubmed: 36882259
pii: bmjopen-2022-061294
doi: 10.1136/bmjopen-2022-061294
pmc: PMC10008337
doi:
Substances chimiques
Adjuvants, Immunologic
0
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
e061294Informations de copyright
© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.
Déclaration de conflit d'intérêts
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.
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