Return to Work for Persistent Spinal Pain Syndrome Type II Patients
NCT ID: NCT05269212
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2022-05-10
2027-08-31
Brief Summary
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Detailed Description
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The primary scientific objective is to examine whether the ability to work in PSPS-T2 patients after SCS implantation is different with a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care. The secondary objective of the study is to examine if a personalized biopsychosocial rehabilitation program specifically targeting RTW, compared to usual care, is different in improving functional capacity, improving work status and participation, obtaining pain relief, increasing health-related quality of life, increasing functioning and physical activity, improving sleep quality, decreasing kinesiophobia, increasing self-management, decreasing anxiety and depression and decreasing healthcare expenditure.
Patients will be randomly allocated (1:1 ratio) to a personalized rehabilitation program or usual care using random, permuted blocks of 2 or 4 patients stratified by investigational site and the duration of sick leave. Participants randomly allocated to the usual care intervention will undergo the usual care trajectory. This program is delivered at each of the participating centres. Patients will follow the usual care as it is implemented in Belgian hospitals, after SCS implantation. Participants randomly allocated to the personalized biopsychosocial return to work program will receive an individualized 14-week rehabilitation program. Therapy is provided at each implantation centres and will start 6 weeks after definitive SCS implantation. Within a 14-week period, patients in this group receive treatment sessions from trained physiotherapists, occupational therapists and psychologists. All therapists will be trained by experts in the different therapy modalities.
Outcome assessments will take place at baseline, immediately before the intervention, immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Usual care
Usual Care trajectory
Usual care after Spinal Cord Stimulation implantation
Personalized biopsychosocial rehabilitation program
A biopsychosocial rehabilitation program
A personalized biopsychosocial rehabilitation program specifically targeting return to work.
Interventions
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Usual Care trajectory
Usual care after Spinal Cord Stimulation implantation
A biopsychosocial rehabilitation program
A personalized biopsychosocial rehabilitation program specifically targeting return to work.
Eligibility Criteria
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Inclusion Criteria
* Chronic pain as a result of PSPS-T2 that exists for at least 6 months with a pain intensity of at least 4/10 on the Numeric Rating Scale, refractory to conservative treatment.
* Dutch speaking persons
* Patient has been informed of the study procedures and has given written informed consent
* Patient willing to comply with study protocol including attending the study visits
Exclusion Criteria
* Pregnancy
18 Years
60 Years
ALL
No
Sponsors
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Vrije Universiteit Brussel
OTHER
University Ghent
OTHER
KU Leuven
OTHER
Moens Maarten
OTHER
Responsible Party
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Moens Maarten
principal investigator
Locations
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UZ Gent
Ghent, , Belgium
Jessa Ziekenhuis
Hasselt, , Belgium
Universitair Ziekenhuis Brussel
Jette, , Belgium
AZ Nikolaas
Sint-Niklaas, , Belgium
AZ Turnhout
Turnhout, , Belgium
Countries
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Central Contacts
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Lisa Goudman, PhD
Role: CONTACT
Facility Contacts
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Sam Schelfout, MD
Role: primary
Mark Plazier, MD PhD
Role: primary
Maarten Moens, MD PhD
Role: primary
Jean-Pierre Van Buyten, MD PhD
Role: primary
Bart Bryon, MD
Role: primary
References
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Moens M, Goudman L, Van de Velde D, Godderis L, Putman K, Callens J, Lavreysen O, Ceulemans D, Leysen L; OPERA consortium; De Smedt A. 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):974. doi: 10.1186/s13063-022-06895-5.
Other Identifiers
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OPERA
Identifier Type: -
Identifier Source: org_study_id
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