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.

Autor: Moens, Maarten, Goudman, Lisa, Van de Velde, Dominique, Godderis, Lode, Putman, Koen, Callens, Jonas, Lavreysen, Olivia, Ceulemans, Dries, Leysen, Laurence, OPERA consortium, Van Buyten, Jean-Pierre, Smet, Iris, Jerjir, Ali, Bryon, Bart, Plazier, Mark, Raymaekers, Vincent, Schelfout, Sam, Crombez, Erwin, Theys, Tom, Van Hoylandt, Anaïs
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Zdroj: Trials; 12/5/2022, Vol. 23 Issue 1, p1-17, 17p, 1 Diagram, 2 Charts
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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