R³ Rehab Pathway Versus Usual Care After Lumbar Radicular 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.
Universitaire Ziekenhuizen KU Leuven
480 participants
Mar 16, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria6
- 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
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Interventions
A structured evidence-based rehabilitation pathway, guided by a case manager, starting preoperatively to 1 year postoperatively, including prehabilitation, perioperative rehabilitation and postoperative rehabilitation, with emphasis on fear reduction by keeping activity restrictions minimal and relevant, eliminating bracing and on active guidance to work resumption.
Locations(16)
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NCT07313566