Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study

OPERA consortium; Maarten Moens; Lisa Goudman; Dominique Van de Velde; Lode Godderis; Koen Putman; Jonas Callens; Olivia Lavreysen; Dries Ceulemans; Laurence Leysen; Ann De Smedt

doi:10.1186/s13063-022-06895-5

Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study

OPERA consortium, Maarten Moens, Lisa Goudman, Dominique Van de Velde, Lode Godderis, Koen Putman, Jonas Callens, Olivia Lavreysen, Dries Ceulemans, Laurence Leysen, Ann De Smedt

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

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Abstract

BACKGROUND: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.

METHODS: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.

DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

Original language	English
Article number	974
Pages (from-to)	1-17
Number of pages	17
Journal	Trials
Volume	23
Issue number	1
DOIs	https://doi.org/10.1186/s13063-022-06895-5
Publication status	Published - 5 Dec 2022

Keywords

Failed back surgery syndrome
Neuromodulation
Personalised medicine
Randomised controlled trial
Rehabilitation

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Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial - the OPERA study
Maarten Moens (Contributor), Lisa Goudman (Contributor), Dominique Van De Velde (Contributor), Lode Godderis (Contributor), Koen Putman (Contributor), Jonas Callens (Presenter), Olivia Lavreysen (Contributor), Dries Ceulemans (Contributor), Laurence Leysen (Contributor) & Ann De Smedt (Contributor)
10 Mar 2023
Activity: Talk or presentation › Talk or presentation at a conference

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OPERA consortium, Moens, M., Goudman, L., Van de Velde, D., Godderis, L., Putman, K., Callens, J., Lavreysen, O., Ceulemans, D., Leysen, L., & De Smedt, A. (2022). Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study. Trials, 23(1), 1-17. [974]. https://doi.org/10.1186/s13063-022-06895-5

OPERA consortium ; Moens, Maarten ; Goudman, Lisa ; Van de Velde, Dominique ; Godderis, Lode ; Putman, Koen ; Callens, Jonas ; Lavreysen, Olivia ; Ceulemans, Dries ; Leysen, Laurence ; De Smedt, Ann. / Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation : a study protocol for a 12-month randomised controlled trial-the OPERA study. In: Trials. 2022 ; Vol. 23, No. 1. pp. 1-17.

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title = "Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study",

abstract = "BACKGROUND: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.METHODS: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.TRIAL REGISTRATION: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.",

keywords = "Failed back surgery syndrome, Neuromodulation, Personalised medicine, Randomised controlled trial, Rehabilitation",

author = "{OPERA consortium} and Maarten Moens and Lisa Goudman and {Van de Velde}, Dominique and Lode Godderis and Koen Putman and Jonas Callens and Olivia Lavreysen and Dries Ceulemans and Laurence Leysen and {De Smedt}, Ann",

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OPERA consortium, Moens, M , Goudman, L, Van de Velde, D, Godderis, L, Putman, K , Callens, J, Lavreysen, O, Ceulemans, D, Leysen, L & De Smedt, A 2022, 'Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study', Trials, vol. 23, no. 1, 974, pp. 1-17. https://doi.org/10.1186/s13063-022-06895-5

Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation : a study protocol for a 12-month randomised controlled trial-the OPERA study. / OPERA consortium ; Moens, Maarten ; Goudman, Lisa; Van de Velde, Dominique; Godderis, Lode; Putman, Koen ; Callens, Jonas; Lavreysen, Olivia; Ceulemans, Dries; Leysen, Laurence ; De Smedt, Ann.

In: Trials, Vol. 23, No. 1, 974, 05.12.2022, p. 1-17.

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

TY - JOUR

T1 - Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation

T2 - a study protocol for a 12-month randomised controlled trial-the OPERA study

AU - OPERA consortium

AU - Moens, Maarten

AU - Goudman, Lisa

AU - Van de Velde, Dominique

AU - Godderis, Lode

AU - Putman, Koen

AU - Callens, Jonas

AU - Lavreysen, Olivia

AU - Ceulemans, Dries

AU - Leysen, Laurence

AU - De Smedt, Ann

PY - 2022/12/5

Y1 - 2022/12/5

N2 - BACKGROUND: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.METHODS: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.TRIAL REGISTRATION: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

AB - BACKGROUND: For patients with therapy-refractory persistent spinal pain syndrome type II (PSPS-T2), spinal cord stimulation (SCS) may serve as an effective minimally invasive treatment. Despite the evidence that SCS can improve return to work (RTW), only 9.5 to 14% of patients implanted with SCS are effectively capable of returning to work. Thus, it seems that current post-operative interventions are not effective for achieving RTW after SCS implantation in clinical practice. The current objective is to examine whether a personalised biopsychosocial rehabilitation programme specifically targeting RTW alters the work ability in PSPS-T2 patients after SCS implantation compared to usual care.METHODS: A two-arm, parallel-group multicentre randomised controlled trial will be conducted including 112 patients who will be randomised (1:1) to either (a) a personalised biopsychosocial RTW rehabilitation programme of 14 weeks or (b) a usual care arm, both with a follow-up period until 12 months after the intervention. The primary outcome is work ability. The secondary outcomes are work status and participation, pain intensity, health-related quality of life, physical activity and functional disability, functional capacities, sleep quality, kinesiophobia, self-management, anxiety, depression and healthcare expenditure.DISCUSSION: Within the OPERA project, we propose a multidisciplinary personalised biopsychosocial rehabilitation programme specifically targeting RTW for patients implanted with SCS, to tackle the high socio-economic burden of patients that are not re-entering the labour market. The awareness is growing that the burden of PSPS-T2 on our society is expected to increase over time due to the annual increase of spinal surgeries. However, innovative and methodologically rigorous trials exploring the potential to decrease the socio-economic burden when patients initiate a trajectory with SCS are essentially lacking.TRIAL REGISTRATION: ClinicalTrials.gov NCT05269212. Registered on 7 March 2022.

KW - Failed back surgery syndrome

KW - Neuromodulation

KW - Personalised medicine

KW - Randomised controlled trial

KW - Rehabilitation

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U2 - 10.1186/s13063-022-06895-5

DO - 10.1186/s13063-022-06895-5

M3 - Article

C2 - 36471349

VL - 23

SP - 1

EP - 17

JO - Trials

JF - Trials

SN - 1745-6215

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M1 - 974

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OPERA consortium, Moens M , Goudman L, Van de Velde D, Godderis L, Putman K et al. Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study. Trials. 2022 Dec 5;23(1):1-17. 974. https://doi.org/10.1186/s13063-022-06895-5

Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial-the OPERA study

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Personalised rehabilitation to improve return to work in patients with persistent spinal pain syndrome type II after spinal cord stimulation implantation: a study protocol for a 12-month randomised controlled trial - the OPERA study

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