Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

Natasha C Pocovi; Petra L Graham; Chung-Wei Christine Lin; Simon D. French; Jane Latimer; Dafna Merom; Anne Tiedemann; Christopher G. Maher; Johanna M. van Dongen; Ornella Clavisi; Mark J. Hancock

doi:10.1186/s13063-023-07119-0

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

Natasha C Pocovi, Petra L Graham, Chung-Wei Christine Lin, Simon D. French, Jane Latimer, Dafna Merom, Anne Tiedemann, Christopher G. Maher, Johanna M. van Dongen, Ornella Clavisi, Mark J. Hancock

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Abstract

Background: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.

Methods: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.

Discussion: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.

TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

Original language	English
Article number	197
Pages (from-to)	1-11
Number of pages	11
Journal	Trials
Volume	24
Issue number	1
DOIs	https://doi.org/10.1186/s13063-023-07119-0
Publication status	Published - 16 Mar 2023

Bibliographical note

Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

Humans
Adult
Low Back Pain/diagnosis
Cost-Benefit Analysis
Quality of Life
Walking
Exercise
Prevention
Statistical analysis plan
Low back pain
Randomised-controlled trial

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WalkBack: Preventing recurrence of low back pain: Is walking the best approach?
Hancock, M. (Primary Chief Investigator), Latimer, J. (Chief Investigator), Lin, C. W. C. (Chief Investigator), Merom, D. (Chief Investigator), vanTulder, M. W. (Chief Investigator), Maher, C. (Associate Investigator), Clavisi, O. (Associate Investigator), MacAskill, P. (Associate Investigator) & Tiedemann, A. (Associate Investigator)
1/01/19 → 31/12/22
Project: Research

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Pocovi, N. C., Graham, P. L., Lin, C.-W. C., French, S. D., Latimer, J., Merom, D., Tiedemann, A., Maher, C. G., van Dongen, J. M., Clavisi, O., & Hancock, M. J. (2023). Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial. Trials, 24(1), 1-11. Article 197. https://doi.org/10.1186/s13063-023-07119-0

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title = "Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial",

abstract = "Background: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.Methods: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.Discussion: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.",

keywords = "Humans, Adult, Low Back Pain/diagnosis, Cost-Benefit Analysis, Quality of Life, Walking, Exercise, Prevention, Statistical analysis plan, Low back pain, Randomised-controlled trial",

author = "Pocovi, {Natasha C} and Graham, {Petra L} and Lin, {Chung-Wei Christine} and French, {Simon D.} and Jane Latimer and Dafna Merom and Anne Tiedemann and Maher, {Christopher G.} and {van Dongen}, {Johanna M.} and Ornella Clavisi and Hancock, {Mark J.}",

note = "Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

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Pocovi, NC , Graham, PL, Lin, C-WC, French, SD, Latimer, J, Merom, D, Tiedemann, A, Maher, CG, van Dongen, JM, Clavisi, O & Hancock, MJ 2023, 'Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial', Trials, vol. 24, no. 1, 197, pp. 1-11. https://doi.org/10.1186/s13063-023-07119-0

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial. / Pocovi, Natasha C ; Graham, Petra L; Lin, Chung-Wei Christine et al.
In: Trials, Vol. 24, No. 1, 197, 16.03.2023, p. 1-11.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults

T2 - statistical analysis plan for the WalkBack randomised controlled trial

AU - Pocovi, Natasha C

AU - Graham, Petra L

AU - Lin, Chung-Wei Christine

AU - French, Simon D.

AU - Latimer, Jane

AU - Merom, Dafna

AU - Tiedemann, Anne

AU - Maher, Christopher G.

AU - van Dongen, Johanna M.

AU - Clavisi, Ornella

AU - Hancock, Mark J.

N1 - Copyright the Author(s) 2023. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2023/3/16

Y1 - 2023/3/16

N2 - Background: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.Methods: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.Discussion: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

AB - Background: Exercise for the prevention of low back pain recurrences is recommended, but under-researched. The effectiveness and cost-effectiveness of a walking program for preventing low back pain recurrence remains unknown. This a priori statistical analysis plan describes the methods of analysis for the WalkBack trial.Methods: WalkBack is a prospectively registered, pragmatic, randomised controlled trial. The aim is to investigate the effectiveness and cost-effectiveness of a 6-month progressive and individualised walking and education program (intervention) for the prevention of low back pain recurrences, compared to a no-treatment control group. The primary outcome is days to the first recurrence of an episode of activity-limiting low back pain. Key secondary outcomes include days to any recurrence of low back pain, days to a care-seeking recurrence of low back pain, disability level, health-related quality of life, costs associated with low back pain and adverse events. All participants will be followed for a minimum of 12 months. Analysis will follow the intention-to-treat principle. Cox regression is planned to assess the effects for the outcomes of time to activity-limiting, minimal and care-seeking recurrence. Hazard ratios and median survival times with 95% confidence intervals will be calculated. The effect of the intervention on continuous outcomes will be estimated with repeated-measure linear mixed models. An economic evaluation will be performed from the societal perspective for recurrence prevented (yes/no) and quality-adjusted life years. The proportion of adverse events between groups will be compared using Fisher's exact test.Discussion: The WalkBack trial will provide evidence on the effectiveness and cost-effectiveness of a walking intervention to prevent low back pain recurrences. This statistical analysis plan provides transparency on the analysis of the trial.TRIAL REGISTRATION: WalkBack - Effectiveness and cost-effectiveness of a progressive individualised walking and education program for the prevention of a recurrence of low back pain. ACTRN12619001134112 . Date Registered: 14/08/2019.

KW - Humans

KW - Adult

KW - Low Back Pain/diagnosis

KW - Cost-Benefit Analysis

KW - Quality of Life

KW - Walking

KW - Exercise

KW - Prevention

KW - Statistical analysis plan

KW - Low back pain

KW - Randomised-controlled trial

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UR - https://purl.org/au-research/grants/nhmrc/GNT1161889

U2 - 10.1186/s13063-023-07119-0

DO - 10.1186/s13063-023-07119-0

M3 - Article

C2 - 36927497

SN - 1745-6215

VL - 24

SP - 1

EP - 11

JO - Trials

JF - Trials

IS - 1

M1 - 197

ER -

Effectiveness and cost-effectiveness of a progressive, individualised walking and education program for prevention of low back pain recurrence in adults: statistical analysis plan for the WalkBack randomised controlled trial

Abstract

Bibliographical note

Keywords

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WalkBack: Preventing recurrence of low back pain: Is walking the best approach?

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