NCT07313566 R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
| NCT ID | NCT07313566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Lumbar Radiculopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 480 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 480 participants in total. It began in 2026-03-16 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The R³ trial is a multicentre cluster randomized controlled trial evaluating an evidence-based, person-centred rehabilitation pathway for patients undergoing lumbar surgery for radicular pain. The pathway includes structured pre-, peri-, and postoperative rehabilitation, early postoperative mobilization, case management, early return-to-work (RTW) guidance, and patient empowerment. Clusters (hospitals) are randomized to implement the R³ pathway (intervention) or continue usual care (control). The primary aim is to determine whether the R³ pathway reduces time to return to work compared with usual care.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07313566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lumbar Radiculopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07313566 currently recruiting?
Yes, NCT07313566 is actively recruiting participants. Contact the research team at olivier.nachtergaele@uzleuven.be for enrollment information.
Where is the NCT07313566 trial being conducted?
This trial is being conducted at Antwerp, Belgium, Bruges, Belgium, Brussels, Belgium, Charleroi, Belgium and 11 additional locations.
Who is sponsoring the NCT07313566 clinical trial?
NCT07313566 is sponsored by Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 480 participants.