R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery (NCT07313566) | Clinical Trial Compass
RecruitingNot Applicable
R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
Belgium480 participantsStarted 2026-03-16
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Time to Return To Work (RTW)
Timeframe: Assessed from surgery to 15 months postoperatively