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ClinicalTrials.gov ID

NCT07313566

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

480Estimated

Last Update Posted

May 5, 2026Actual

Start Date

Mar 16, 2026Actual

Primary Completion Date

May 2028Estimated

Completion Date

May 2028Estimated

Official Title

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.

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.

• Lumbar Radiculopathy
• Radicular Low Back Pain

• R³ Rehabilitation Pathway

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Federal Knowledge Centre (KCE)UNKNOWN

christophe.oosterbos@zol.be+3289326043

olivier.nachtergaele@uzleuven.be

luc.barras@cspo.be+3210437383