R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

NCT ID: NCT07313566

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-05-31

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.

Conditions

Lumbar Radiculopathy; Radicular Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention: R³ Rehabilitation Pathway

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.

Group Type: EXPERIMENTAL

R³ Rehabilitation Pathway

Intervention Type: OTHER

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.

Control: usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

R³ Rehabilitation Pathway

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federal Knowledge Centre (KCE)

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ZAS

Antwerp, , Belgium

AZ Sint Jan Brugge

Bruges, , Belgium

UZ Brussel

Brussels, , Belgium

Grand Hôpital de Charleroi

Charleroi, , Belgium

Ziekenhuis Geel

Geel, , Belgium

ZOL Genk

Genk, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

AZ Herentals

Herentals, , Belgium

Jan Yperman ziekenhuis

Ieper, , Belgium

AZ Groeninge Kortrijk

Kortrijk, , Belgium

UZ Leuven

Leuven, , Belgium

Heilig Hart Lier

Lier, , Belgium

AZ Sint Maarten Mechelen

Mechelen, , Belgium

CSPO

Ottignies, , Belgium

AZ Delta Roeselare

Roeselare, , Belgium

Centre Hospitalier de Wallonie Picarde

Tournai, , Belgium

Countries

Belgium

Central Contacts

Olivier Nachtergaele, MD

Role: CONTACT

olivier.nachtergaele@uzleuven.be

+32 16 34 02 72

Facility Contacts

Kris De Smedt, MD

Role: primary

kris.desmedt@zas.be

+323 443 37 71

Evelyne Linden, MD

Role: primary

evelyne.linden@azsintjan.be

+32 (0)50 36 50 30

Marc Schiltz, MD, PhD

Role: primary

marc.schiltz@uzbrussel.be

+32 (0)2 477 77 12

Maxime Valet, MD

Role: primary

maxime.valet@ghdc.be

+32 71 10 69 43

Arne Heyns, MD

Role: primary

arne.heyns@ziekenhuisgeel.be

+3214 57 70 35

Christophe Oosterbos, MD

Role: primary

christophe.oosterbos@zol.be

+3289326043

Kristof Kempeneers, MD

Role: primary

kristof.kempeneers@jessazh.be

+3211338812

Maarten Rombauts, MD

Role: primary

maarten.rombauts@azherentals.be

+3214 24 61 60

Kristof Vermeersch, MD

Role: primary

kristof.vermeersch@yperman.net

+3257 35 73 80

Michael Bultheel, MD

Role: primary

michael.bultheel@azgroeninge.be

+3256 63 32 00

Olivier Nachtergaele, MD

Role: primary

olivier.nachtergaele@uzleuven.be

Michael Schreurs, MD

Role: primary

Michael.Schreurs@heilighartlier.be

+3234912209

Pieter Jan Van Dyck-Lippens, MD

Role: primary

pieterjan.van.dyck-lippens@emmaus.be

+3215 89 37 32

Luc Barras, MD

Role: primary

luc.barras@cspo.be

+3210437383

Jeroen Van Lerbeirghe, MD

Role: primary

jeroen.vanlerbeirghe@azdelta.be

+32 (0)51 23 74 17

Jordan Assaker, MD

Role: primary

jordan.assaker@chwapi.be

+32 (0)69331349

Other Identifiers

KCE23-1473

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S68181

Identifier Type: -

Identifier Source: org_study_id