R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
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 managemen
| Condition(s) | Lumbar Radiculopathy, Radicular Low Back Pain |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 | 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 stud |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
| Locations | Antwerp, Belgium; Bruges, Belgium; Brussels, Belgium; Charleroi, Belgium; Geel, Belgium; Genk, Belgium (+10 more sites) |
| Start date | 2026-03-16 |
| NCT ID | NCT07313566 |
| Official listing | https://clinicaltrials.gov/study/NCT07313566 |