R³ rehabilitation pathway versus usual care after lumbar nerve-root surgery
An Evidence-based Rehabilitation Pathway for Patients Undergoing Surgery for Lumbar Radicular Pain to Promote Return to Work: a Cluster Randomized Trial Comparison With Usual Care.
This program tests whether a structured R³ rehab pathway helps adults aged 18–65 having lumbar nerve-root surgery return to work faster than usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 16 sites (Antwerp and 15 other locations) |
| Trial ID | NCT07313566 on ClinicalTrials.gov |
What this trial studies
R³ is a multicentre cluster randomized trial in which hospitals are randomized to implement an evidence-based, person-centred rehabilitation pathway or continue usual care. The pathway includes structured pre-, peri-, and postoperative rehabilitation, early postoperative mobilization, case management, early return-to-work guidance, and patient empowerment. The trial enrolls employed adults with radicular lumbar pain scheduled for (micro)discectomy, decompression, or one- to two-level fusion and measures time to return to work as the primary outcome. Multiple Belgian university and regional hospitals participate to compare the pathway against routine postoperative management.
Who should consider this trial
Good fit: Adults aged 18–65 with radicular lumbar pain scheduled for lumbar decompression/discectomy or one- to two-level fusion who are employed or on sick leave for less than one year are ideal candidates.
Not a fit: Patients having surgery for malignancy, non-radicular indications, those unemployed long-term, or those unable to participate in rehabilitation activities are unlikely to benefit from this pathway.
Why it matters
Potential benefit: If successful, the R³ pathway could shorten time to return to work and improve recovery, functional outcomes, and patient confidence after lumbar radicular surgery.
How similar studies have performed: Coordinated rehabilitation and early mobilization approaches have shown promise for improving return-to-work and function after lumbar surgery, but large multicenter randomized evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Radicular pain (for ≥ 6 weeks prior to screening), with a clear indication for lumbar spinal surgery ((micro)discectomy, decompression and/or fusion), in accordance with the KCE guidelines (when evidence-based multimodal management has not improved pain or function and radiological findings are consistent with clinical symptoms) * Employed (working or on sick leave for less than 1 year due to spinal pathology) * Age 18 - 65 years * Surgery is scheduled within a timeframe of five days to 2 months after the decision for surgery (4 months for fusion) * For lumbar fusion surgery, the fusion should be restricted to one or two levels * Able to provide written informed consent, implying that the participant is both physically and cognitively capable of understanding the study information and signing the consent form independently. Exclusion Criteria: Patients are not eligible for the trial in case of any of the following criteria: * Lumbar surgery performed for malignant disease, spinal fracture, infectious spinal disease * Insufficient knowledge of Dutch or French language to receive education in the recruiting center and to complete the questionnaires (consistent with the language spoken in the recruiting centre) * Immediate surgery via emergency admission that precludes prehabilitation * Revision fusion surgery * Non-residency in Belgium
Where this trial is running
Antwerp and 15 other locations
- Zas — Antwerp, Belgium (Not_yet_recruiting)
- AZ Sint Jan Brugge — Bruges, Belgium (Recruiting)
- UZ Brussel — Brussels, Belgium (Not_yet_recruiting)
- Grand Hôpital de Charleroi — Charleroi, Belgium (Not_yet_recruiting)
- Ziekenhuis Geel — Geel, Belgium (Not_yet_recruiting)
- ZOL Genk — Genk, Belgium (Recruiting)
- Jessa Ziekenhuis — Hasselt, Belgium (Not_yet_recruiting)
- AZ Herentals — Herentals, Belgium (Not_yet_recruiting)
- Jan Yperman ziekenhuis — Ieper, Belgium (Not_yet_recruiting)
- AZ Groeninge Kortrijk — Kortrijk, Belgium (Not_yet_recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- Heilig Hart Lier — Lier, Belgium (Recruiting)
- AZ Sint Maarten Mechelen — Mechelen, Belgium (Not_yet_recruiting)
- Cspo — Ottignies, Belgium (Not_yet_recruiting)
- AZ Delta Roeselare — Roeselare, Belgium (Not_yet_recruiting)
- Centre Hospitalier de Wallonie Picarde — Tournai, Belgium (Not_yet_recruiting)
Study contacts
- Study coordinator: Olivier Nachtergaele, MD
- Email: olivier.nachtergaele@uzleuven.be
- Phone: +32 16 34 02 72
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.