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., Latimer, J., Lin, C. W. C., Merom, D., vanTulder, M. W., Maher, C., Clavisi, O., MacAskill, P. & Tiedemann, A.
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.",

year = "2023",

month = mar,

day = "16",

doi = "10.1186/s13063-023-07119-0",

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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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