Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID07313566

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

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Run-in Period

Duration - Up to 2 months before surgery

Participants undergo prehabilitation as part of a structured rehabilitation pathway starting before surgery.

Treatment

Duration - Up to 1 year postoperatively

Participants receive the rehabilitation intervention starting perioperatively and continuing postoperatively, focusing on active guidance and minimal activity restrictions.

Follow-up

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

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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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