Davies, B;
Mowforth, OD;
Yordanov, S;
Alvarez-Berdugo, D;
Bond, S;
Nodale, M;
Kareclas, P;
... Kotter, MRN; + view all
(2023)
Targeting patient recovery priorities in degenerative cervical myelopathy: Design and rationale for the RECEDE-Myelopathy trial - Study protocol.
BMJ Open
, 13
(3)
, Article e061294. 10.1136/bmjopen-2022-061294.
Preview |
Text
e061294.full.pdf - Published Version Download (1MB) | Preview |
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.
| Type: | Article |
|---|---|
| Title: | Targeting patient recovery priorities in degenerative cervical myelopathy: Design and rationale for the RECEDE-Myelopathy trial - Study protocol |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1136/bmjopen-2022-061294 |
| Publisher version: | https://doi.org/10.1136/bmjopen-2022-061294 |
| Language: | English |
| Additional information: | This work is licensed under a Creative Commons Attribution 4.0 International License. The images or other third-party material in this article are included in the Creative Commons license, unless indicated otherwise in the credit line; if the material is not included under the Creative Commons license, users will need to obtain permission from the license holder to reproduce the material. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/ |
| Keywords: | Neurosurgery, spine, Adult, Humans, Spinal Cord Diseases, Neck, Adjuvants, Immunologic, Bone Marrow Diseases, Pain, Randomized Controlled Trials as Topic, Multicenter Studies as Topic |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Brain Sciences > UCL Queen Square Institute of Neurology > Brain Repair and Rehabilitation |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10167404 |
Archive Staff Only
 |
View Item |
