Improving Return to Work After Spinal Cord Stimulation in Persistent Spinal Pain Syndrome Type II Patients
A Personalized Biopsychosocial Rehabilitation Program Compared to Usual Care
A Multicenter Randomized Controlled Trial
Led by Moens Maarten · Updated on 2025-10-02
112
Participants Needed
5
Research Sites
N/A
Total Duration
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
Research Team
M
Maarten Moens, Prof. dr.
L
Lisa Goudman, PhD
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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
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
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
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...