Return to Work for Persistent Spinal Pain Syndrome Type II Patients
OPERA
Objectifying Performance Assessments and Personalized Rehabilitation Trajectories to Improve Return to Work in Patients With Persistent Spinal Pain Syndrome Type II: a Randomized Controlled Trial.
1 other identifier
interventional
112
1 country
5
Brief Summary
A multicenter randomized controlled trial will be conducted to evaluate whether the ability to work in Persistent Spinal Pain Syndrome Type II (PSPS-T2) patients after SCS implantation is different after a personalized biopsychosocial rehabilitation program specifically targeting return to work (RTW) compared with usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2022
CompletedFirst Posted
Study publicly available on registry
March 7, 2022
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
October 2, 2025
October 1, 2025
5.2 years
February 8, 2022
October 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Work ability
Work ability, evaluated with the Work Ability Index
The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Secondary Outcomes (11)
Functional capacity evaluation
The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Work status and participation
The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Overall pain intensity with Visual Analogue Scale (VAS)
The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Health related quality of life
The change between the baseline screening and the evaluation immediately after the intervention, 3 months after the intervention, 6 months after the intervention and 12 months after the intervention.
Physical activity
The change between the baseline screening and the evaluation immediately after the intervention, 6 months after the intervention and 12 months after the intervention.
- +6 more secondary outcomes
Study Arms (2)
Usual care
ACTIVE COMPARATORPersonalized biopsychosocial rehabilitation program
ACTIVE COMPARATORInterventions
A personalized biopsychosocial rehabilitation program specifically targeting return to work.
Eligibility Criteria
You may qualify if:
- Persistent Spinal Pain Syndrome Type II (PSPS-T2)
- 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
You may not qualify if:
- Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Moens Maartenlead
- Vrije Universiteit Brusselcollaborator
- University Ghentcollaborator
- KU Leuvencollaborator
Study Sites (5)
UZ Gent
Ghent, Belgium
Jessa Ziekenhuis
Hasselt, Belgium
Universitair Ziekenhuis Brussel
Jette, 1090, Belgium
AZ Nikolaas
Sint-Niklaas, Belgium
AZ Turnhout
Turnhout, Belgium
Related Publications (1)
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.
PMID: 36471349DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Lisa Goudman, PhD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
February 8, 2022
First Posted
March 7, 2022
Study Start
May 10, 2022
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
October 2, 2025
Record last verified: 2025-10