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 Wilby; David Choi; Ian B Wilkinson; Michael G Fehlings; Peter John Hutchinson; Mark R N Kotter

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, 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 journal › Article › peer-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.

TRIAL REGISTRATION NUMBER: ISRCTN Number: ISRCTN16682024.

Original language	English
Article number	e061294
Pages (from-to)	e061294
Journal	BMJ Open
Volume	13
Issue number	3
DOIs	https://doi.org/10.1136/bmjopen-2022-061294
Publication status	Published - 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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10.1136/bmjopen-2022-061294

e061294.fullFinal published version, 1.01 MBLicence: Creative Commons: Attribution (CC-BY)

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Davies, B., Mowforth, O. D., Yordanov, S., Alvarez-Berdugo, D., Bond, S., Nodale, M., Kareclas, P., Whitehead, L., Bishop, J., Chandran, S., Lamb, S., Bacon, M., Papadopoulos, M. C., Starkey, M., Sadler, I., Smith, L., Kalsi-Ryan, S., Carpenter, A., Trivedi, R. A., ... Kotter, M. R. N. (2023). Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol. BMJ Open, 13(3), e061294. Article e061294. https://doi.org/10.1136/bmjopen-2022-061294

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

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

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

note = "{\textcopyright} Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.",

year = "2023",

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doi = "10.1136/bmjopen-2022-061294",

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Davies, B, Mowforth, OD, Yordanov, S, Alvarez-Berdugo, D, Bond, S, Nodale, M, Kareclas, P, Whitehead, L, Bishop, J, Chandran, S, Lamb, S, Bacon, M, Papadopoulos, MC, Starkey, M, Sadler, I, Smith, L, Kalsi-Ryan, S, Carpenter, A, Trivedi, RA, Wilby, M, Choi, D, Wilkinson, IB, Fehlings, MG, Hutchinson, PJ & Kotter, MRN 2023, 'Targeting patient recovery priorities in degenerative cervical myelopathy: design and rationale for the RECEDE-Myelopathy trial-study protocol', BMJ Open, vol. 13, no. 3, e061294, pp. e061294. https://doi.org/10.1136/bmjopen-2022-061294

TY - JOUR

T1 - Targeting patient recovery priorities in degenerative cervical myelopathy

T2 - design and rationale for the RECEDE-Myelopathy trial-study protocol

AU - Davies, Benjamin

AU - Mowforth, Oliver D

AU - Yordanov, Stefan

AU - Alvarez-Berdugo, Daniel

AU - Bond, Simon

AU - Nodale, Marianna

AU - Kareclas, Paula

AU - Whitehead, Lynne

AU - Bishop, Jon

AU - Chandran, Siddharthan

AU - Lamb, Sarah

AU - Bacon, Mark

AU - Papadopoulos, Marios C

AU - Starkey, Michelle

AU - Sadler, Iwan

AU - Smith, Lara

AU - Kalsi-Ryan, Sukhvinder

AU - Carpenter, Adrian

AU - Trivedi, Rikin A

AU - Wilby, Martin

AU - Choi, David

AU - Wilkinson, Ian B

AU - Fehlings, Michael G

AU - Hutchinson, Peter John

AU - Kotter, Mark R N

PY - 2023/3/7

Y1 - 2023/3/7

N2 - 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.

AB - 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.

KW - Adult

KW - Humans

KW - Spinal Cord Diseases

KW - Neck

KW - Adjuvants, Immunologic

KW - Bone Marrow Diseases

KW - Pain

KW - Randomized Controlled Trials as Topic

KW - Multicenter Studies as Topic

U2 - 10.1136/bmjopen-2022-061294

DO - 10.1136/bmjopen-2022-061294

M3 - Article

C2 - 36882259

SN - 2044-6055

VL - 13

SP - e061294

JO - BMJ Open

JF - BMJ Open

IS - 3

M1 - e061294

ER -

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

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Keywords / Materials (for Non-textual outputs)

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