Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
ID05269212

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

Led by Moens Maarten · Updated on 2025-10-02

112

Participants Needed

5

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Moens Maarten

Lead Sponsor

V

Vrije Universiteit Brussel

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting a multicenter randomized controlled trial to assess whether a personalized biopsychosocial rehabilitation program focused on return to work improves work ability in patients with Persistent Spinal Pain Syndrome Type II (PSPS-T2) after spinal cord stimulation (SCS) implantation. The study also aims to evaluate if this program differs from usual care in terms of functional capacity, work participation, pain relief, quality of life, physical activity, sleep quality, anxiety and depression, self-management skills, and healthcare use. Participants will be randomly assigned to one of two groups. One group will receive usual care following SCS implantation as practiced in Belgian hospitals. The other group will undergo an individualized 14-week rehabilitation program starting 6 weeks after SCS implantation. This personalized program includes treatment sessions led by trained physiotherapists, occupational therapists, and psychologists. Therapists receive expert training in the various therapy methods used. Participants will undergo assessments at several time points: at baseline, immediately before and after the intervention, then 3, 6, and 12 months post-intervention. These evaluations will measure changes in work ability, functional capacity, pain intensity, work status, quality of life, physical activity, sleep quality, fear of movement, self-management skills, anxiety, depression, and healthcare use. The total duration of participation spans over a year, allowing researchers to observe both short- and long-term outcomes.

CONDITIONS

Brief Title

Return to Work for Persistent Spinal Pain Syndrome Type II Patients

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Persistent Spinal Pain Syndrome Type II (PSPS-T2)
  • Chronic pain from PSPS-T2 lasting at least 6 months with pain intensity of at least 4 out of 10
  • Dutch-speaking individuals
  • Provided written informed consent after being informed about the study
  • Willing to follow the study protocol and attend all study visits
Not Eligible

You will not qualify if you...

  • Having another chronic illness with widespread chronic pain such as rheumatoid arthritis, fibromyalgia, chronic fatigue syndrome, or scleroderma
  • Pregnancy

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 14 weeks

Participants receive either a personalized 14-week biopsychosocial rehabilitation program targeting return to work starting 6 weeks after Spinal Cord Stimulation implantation, or usual care as implemented in Belgian hospitals after implantation.

Treatment sessions with physiotherapists, occupational therapists, and psychologists over 14 weeks

Follow-up

Duration - 12 months

Participants undergo outcome assessments to evaluate work ability, functional capacity, pain, quality of life, physical activity, and other health measures up to 12 months after the intervention.

Assessments immediately after intervention, and at 3, 6, and 12 months post-intervention

Trial Site Locations

Total: 5 locations

1

UZ Gent

Ghent, Belgium

Actively Recruiting

2

Jessa Ziekenhuis

Hasselt, Belgium

Actively Recruiting

3

Universitair Ziekenhuis Brussel

Jette, Belgium, 1090

Actively Recruiting

4

AZ Nikolaas

Sint-Niklaas, Belgium

Not Yet Recruiting

5

AZ Turnhout

Turnhout, Belgium

Not Yet Recruiting

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Research Team

M

Maarten Moens, Prof. dr.

L

Lisa Goudman, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Maarten Moens, Lisa Goudman, Dominique Van de Velde...

https://pubmed.ncbi.nlm.nih.gov/36471349