Helping patients with persistent spinal pain return to work
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.
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 5 sites (Ghent and 4 other locations) |
| Trial ID | NCT05269212 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with other chronic illnesses characterized by widespread pain or those who are pregnant may not benefit from this study.
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 performed: Previous studies have shown promising results with similar biopsychosocial rehabilitation approaches, indicating potential for success in this trial.
Eligibility criteria
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 this trial is running
Ghent and 4 other locations
- 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
- Study coordinator: Maarten Moens, Prof. dr.
- Email: stimulusresearchgroup@gmail.com
- Phone: +3224775514
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.