Clinical trial Recruiting at 3 sites Interventional Ages 18 to 60

Helping patients with persistent spinal pain return to work

Official title: 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.

Run by Universitair Ziekenhuis Brussel · NCT05269212 · Data updated 2026-11-12

This study is testing a personalized rehabilitation program to see if it helps people with persistent spinal pain return to work after getting spinal cord stimulation.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment112 (estimated)
SponsorUniversitair Ziekenhuis Brussel
Academic / other
Locations5 sites (Ghent and 4 other locations)
StatusRecruiting
StartedMay 10, 2022
Main results expectedAugust 2027
Study endsAugust 2027
Registry record updatedOctober 2, 2025
Trial IDNCT05269212 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are Dutch-speaking adults suffering from Persistent Spinal Pain Syndrome Type II with chronic pain lasting at least six months.

Probably not a fit

Patients with other chronic illnesses characterized by widespread pain or those who are pregnant may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to evaluate the effectiveness of a personalized biopsychosocial rehabilitation program designed to help patients with Persistent Spinal Pain Syndrome Type II (PSPS-T2) return to work after spinal cord stimulation (SCS) implantation. Participants will be randomly assigned to either the personalized rehabilitation program or usual care, with the primary goal of assessing differences in work ability post-treatment. Secondary objectives include improvements in functional capacity, pain relief, health-related quality of life, and mental health outcomes. The study will be conducted across multiple centers in Belgium.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the ability of patients with PSPS-T2 to return to work and improve their overall quality of life.

How similar studies have gone: Previous studies have shown promising results with similar biopsychosocial rehabilitation approaches, indicating potential for success in this trial.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* Suffering from another chronic illness characterised by chronic generalized widespread pain (e.g. rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, scleroderma).
* Pregnancy

Where it's running

  • UZ Gent
    Ghent, Belgium
    Recruiting
  • Jessa Ziekenhuis
    Hasselt, Belgium
    Recruiting
  • Universitair Ziekenhuis Brussel
    Jette, Belgium
    Recruiting
  • AZ Nikolaas
    Sint-Niklaas, Belgium
    Not yet recruiting
  • AZ Turnhout
    Turnhout, Belgium
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.