Advanced search
1 file | 2.20 MB Add to list

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

(2022) TRIALS. 23(1).
Author
Organization
Project
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.
Keywords
Pharmacology (medical), Medicine (miscellaneous), Randomised controlled trial, Personalised medicine, Neuromodulation, Failed back surgery syndrome, Rehabilitation

Downloads

  • published version.pdf
    • full text (Published version)
    • |
    • open access
    • |
    • PDF
    • |
    • 2.20 MB

Citation

Please use this url to cite or link to this publication:

MLA
Moens, Maarten, 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, vol. 23, no. 1, Springer Science and Business Media LLC, 2022, doi:10.1186/s13063-022-06895-5.
APA
Moens, M., Goudman, L., Van de Velde, D., Godderis, L., Putman, K., Callens, J., … Leyman, 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). https://doi.org/10.1186/s13063-022-06895-5
Chicago author-date
Moens, Maarten, Lisa Goudman, Dominique Van de Velde, Lode Godderis, Koen Putman, Jonas Callens, Olivia Lavreysen, et al. 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). https://doi.org/10.1186/s13063-022-06895-5.
Chicago author-date (all authors)
Moens, Maarten, Lisa Goudman, Dominique Van de Velde, Lode Godderis, Koen Putman, Jonas Callens, Olivia Lavreysen, Dries Ceulemans, Laurence Leysen, Ann De Smedt, [missing] OPERA consortium, Jean-Pierre Van Buyten, Iris Smet, Ali Jerjir, Bart Bryon, Mark Plazier, Vincent Raymaekers, Sam Schelfout, Erwin Crombez, Tom Theys, Anaïs Van Hoylandt, Philippe De Vloo, Bart Nuttin, Lieven Annemans, Elien Van der Gucht, and Anneleen Leyman. 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). doi:10.1186/s13063-022-06895-5.
Vancouver
1.
Moens M, Goudman L, Van de Velde D, Godderis L, Putman K, Callens J, 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;23(1).
IEEE
[1]
M. Moens 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, vol. 23, no. 1, 2022.
@article{01H618ZYT6NBV3JY5P5C2EPVK1,
  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.}},
  articleno    = {{974}},
  author       = {{Moens, Maarten and Goudman, Lisa and Van de Velde, Dominique and Godderis, Lode and Putman, Koen and Callens, Jonas and Lavreysen, Olivia and Ceulemans, Dries and Leysen, Laurence and De Smedt, Ann and OPERA consortium, [missing] and Van Buyten, Jean-Pierre and Smet, Iris and Jerjir, Ali and Bryon, Bart and Plazier, Mark and Raymaekers, Vincent and Schelfout, Sam and Crombez, Erwin and Theys, Tom and Van Hoylandt, Anaïs and De Vloo, Philippe and Nuttin, Bart and Annemans, Lieven and Van der Gucht, Elien and Leyman, Anneleen}},
  issn         = {{1745-6215}},
  journal      = {{TRIALS}},
  keywords     = {{Pharmacology (medical),Medicine (miscellaneous),Randomised controlled trial,Personalised medicine,Neuromodulation,Failed back surgery syndrome,Rehabilitation}},
  language     = {{eng}},
  number       = {{1}},
  pages        = {{17}},
  publisher    = {{Springer Science and Business Media LLC}},
  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}},
  url          = {{http://doi.org/10.1186/s13063-022-06895-5}},
  volume       = {{23}},
  year         = {{2022}},
}

Altmetric
View in Altmetric
Web of Science
Times cited: