R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

Universitaire Ziekenhuizen KU Leuven

Status: Not yet enrolling

Conditions: Lumbar Radiculopathy; Radicular Low Back Pain

Treatments: Other: R³ Rehabilitation Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT07313566

KCE23-1473 (Other Grant/Funding Number)

S68181

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Intervention: R³ Rehabilitation Pathway

Experimental group

Description:

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.

Treatment:

Other: R³ Rehabilitation Pathway

Control: usual care

No Intervention group

Description:

Usual care, i.e. usual, variable rehabilitation care, which may vary between and within hospitals and may include no rehabilitation, monodisciplinary or multidisciplinary care, with highly variable advice to the patients