Actively Recruiting
An Evidence-Based Rehabilitation Pathway for Patients Undergoing Surgery for Lumbar Radicular Pain to Promote Return to Work Compared With Usual Care
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-05-05
480
Participants Needed
16
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
F
Federal Knowledge Centre (KCE)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a structured, evidence-based rehabilitation pathway called the R³ pathway for patients undergoing lumbar surgery due to radicular pain. This multicenter cluster randomized controlled trial compares the R³ pathway against usual care to see if it can reduce the time it takes for patients to return to work after surgery. The study focuses on patients aged 18 to 65 scheduled for lumbar spinal surgery with radicular pain lasting at least six weeks. The R³ rehabilitation pathway involves coordinated care guided by a case manager, starting before surgery and continuing up to one year afterward. It includes prehabilitation, perioperative rehabilitation, and postoperative rehabilitation, aiming to reduce fear by minimizing unnecessary activity restrictions, eliminating bracing, and actively encouraging return to work. Hospitals are randomized to either implement the R³ pathway or continue with their usual variable rehabilitation care, which may include no rehabilitation or various types of therapy. Participants will be monitored from surgery through 15 months postoperatively. Researchers will assess the time to return to work as the primary outcome. Secondary outcomes include disability, percentage of patients returned to work, functional status, back and leg pain, health-related quality of life, work productivity, analgesic use, kinesiophobia, and pain catastrophizing at multiple time points. The study requires written consent and involves follow-up assessments to evaluate recovery and work reintegration.
CONDITIONS
Brief Title
R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Radicular pain lasting 6 weeks or more before screening, with a clear indication for lumbar spinal surgery following guidelines
- Employed or on sick leave for less than 1 year due to spinal problems
- Age between 18 and 65 years
- Surgery scheduled between 5 days and 2 months after decision (up to 4 months for fusion surgery)
- For lumbar fusion, limited to one or two levels
- Able to provide written informed consent and understand study information independently
You will not qualify if you...
- Lumbar surgery for malignant disease, spinal fracture, or infectious spinal disease
- Insufficient knowledge of Dutch or French to receive education and complete questionnaires
- Immediate emergency surgery preventing prehabilitation
- Revision fusion surgery
- Not residing in Belgium
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 months before surgery
Participants undergo prehabilitation as part of a structured rehabilitation pathway starting before surgery.
Duration - Up to 1 year postoperatively
Participants receive the rehabilitation intervention starting perioperatively and continuing postoperatively, focusing on active guidance and minimal activity restrictions.
Duration - Up to 15 months postoperatively
Participants are monitored for recovery and return to work after surgery and rehabilitation.
Visits at 4 weeks, 3 months, 12 months, and 15 months postoperatively
Trial Site Locations
Total: 16 locations
1
ZAS
Antwerp, Belgium
Not Yet Recruiting
2
AZ Sint Jan Brugge
Bruges, Belgium
Actively Recruiting
3
UZ Brussel
Brussels, Belgium
Not Yet Recruiting
4
Grand Hôpital de Charleroi
Charleroi, Belgium
Not Yet Recruiting
5
Ziekenhuis Geel
Geel, Belgium
Not Yet Recruiting
6
ZOL Genk
Genk, Belgium
Actively Recruiting
7
Jessa Ziekenhuis
Hasselt, Belgium
Not Yet Recruiting
8
AZ Herentals
Herentals, Belgium
Not Yet Recruiting
9
Jan Yperman ziekenhuis
Ieper, Belgium
Not Yet Recruiting
10
AZ Groeninge Kortrijk
Kortrijk, Belgium
Not Yet Recruiting
11
UZ Leuven
Leuven, Belgium
Actively Recruiting
12
Heilig Hart Lier
Lier, Belgium
Actively Recruiting
13
AZ Sint Maarten Mechelen
Mechelen, Belgium
Not Yet Recruiting
14
CSPO
Ottignies, Belgium
Not Yet Recruiting
15
AZ Delta Roeselare
Roeselare, Belgium
Not Yet Recruiting
16
Centre Hospitalier de Wallonie Picarde
Tournai, Belgium
Not Yet Recruiting
Research Team
O
Olivier Nachtergaele, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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