R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- R³ Rehabilitation Pathway
Treatment groups
480 Participants
are divided into 2 treatment groupsSponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Federal Knowledge Centre (KCE)
Collaborator
Source ClinicalTrials.gov