R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery (R³)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Radiculopathy; Radicular Low Back Pain
• Intervention / Treatment: Other: R³ Rehabilitation Pathway

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olivier Nachtergaele, MD; Phone Number: +32 16 34 02 72; Email: olivier.nachtergaele@uzleuven.be

Study Locations

• Belgium
  • Antwerp, Belgium
    • Not yet recruiting
    • ZAS
    • Contact: Kris De Smedt, MD; Phone Number: +323 443 37 71; Email: kris.desmedt@zas.be
  • Bruges, Belgium
    • Recruiting
    • AZ Sint Jan Brugge
    • Contact: Evelyne Linden, MD; Phone Number: +32 (0)50 36 50 30; Email: evelyne.linden@azsintjan.be
  • Brussels, Belgium
    • Not yet recruiting
    • UZ Brussel
    • Contact: Marc Schiltz, MD, PhD; Phone Number: +32 (0)2 477 77 12; Email: marc.schiltz@uzbrussel.be
  • Charleroi, Belgium
    • Not yet recruiting
    • Grand Hôpital de Charleroi
    • Contact: Maxime Valet, MD; Phone Number: +32 71 10 69 43; Email: maxime.valet@ghdc.be
  • Geel, Belgium
    • Not yet recruiting
    • Ziekenhuis Geel
    • Contact: Arne Heyns, MD; Phone Number: +3214 57 70 35; Email: arne.heyns@ziekenhuisgeel.be
  • Genk, Belgium
    • Recruiting
    • ZOL GENK
    • Contact: Christophe Oosterbos, MD; Phone Number: +3289326043; Email: christophe.oosterbos@zol.be
  • Hasselt, Belgium
    • Not yet recruiting
    • Jessa Ziekenhuis
    • Contact: Kristof Kempeneers, MD; Phone Number: +3211338812; Email: kristof.kempeneers@jessazh.be
  • Herentals, Belgium
    • Not yet recruiting
    • AZ Herentals
    • Contact: Maarten Rombauts, MD; Phone Number: +3214 24 61 60; Email: maarten.rombauts@azherentals.be
  • Ieper, Belgium
    • Not yet recruiting
    • Jan Yperman Ziekenhuis
    • Contact: Kristof Vermeersch, MD; Phone Number: +3257 35 73 80; Email: kristof.vermeersch@yperman.net
  • Kortrijk, Belgium
    • Not yet recruiting
    • AZ Groeninge Kortrijk
    • Contact: Michael Bultheel, MD; Phone Number: +3256 63 32 00; Email: michael.bultheel@azgroeninge.be
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven
    • Contact: Olivier Nachtergaele, MD; Email: olivier.nachtergaele@uzleuven.be
  • Lier, Belgium
    • Recruiting
    • Heilig Hart Lier
    • Contact: Michael Schreurs, MD; Phone Number: +3234912209; Email: Michael.Schreurs@heilighartlier.be
  • Mechelen, Belgium
    • Not yet recruiting
    • Az Sint Maarten Mechelen
    • Contact: Pieter Jan Van Dyck-Lippens, MD; Phone Number: +3215 89 37 32; Email: pieterjan.van.dyck-lippens@emmaus.be
  • Ottignies, Belgium
    • Not yet recruiting
    • CSPO
    • Contact: Luc Barras, MD; Phone Number: +3210437383; Email: luc.barras@cspo.be
  • Roeselare, Belgium
    • Not yet recruiting
    • AZ Delta Roeselare
    • Contact: Jeroen Van Lerbeirghe, MD; Phone Number: +32 (0)51 23 74 17; Email: jeroen.vanlerbeirghe@azdelta.be
  • Tournai, Belgium
    • Not yet recruiting
    • Centre Hospitalier de Wallonie Picarde
    • Contact: Jordan Assaker, MD; Phone Number: +32 (0)69331349; Email: jordan.assaker@chwapi.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Return To Work (RTW)	Time to return to work, defined as at least 50% of the contractional work time before surgery (with a sustainable return to work being defined as remaining actively working for three months following work resumption). Outcome type: Time-to-event (days) Range: 0 to 450 days Interpretation: Shorter time indicates a better outcome	Assessed from surgery to 15 months postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability	Disability scores assessed by the Oswestry Disability Index (ODI) at 3 months and 1 year postoperatively (key-secondary) Scale range: 0-100 points Interpretation: Higher scores indicate greater disability (worse outcome)	3 months and 12 months postoperatively
Percentage of patients returned to work	Percentage of patients returned to work at 4 weeks, 3 months and 1 year postoperatively Scale range: 0-100% Interpretation: Higher percentages indicate a better outcome	4 weeks, 3 months and 1 year postoperatively
Patient-centered functional status	Patient-centered functional status assessed by the Patient-Specific Functional Scale (PSFS) at 4 weeks, 3 months and 1 year postoperatively Scale range: 0-10 per activity (mean score calculated) Interpretation: Higher scores indicate better functional ability	4 weeks, 3 months and 1 year postoperatively
Back pain	Back pain measured with the Numeric Rating Scale (NRS) at 4 weeks, 3 months and 1 year postoperatively Scale range: 0-10 0 = no pain 10 = worst imaginable pain Interpretation: Higher scores indicate more severe pain (worse outcome)	4 weeks, 3 months and 1 year postoperatively
Leg pain	Leg pain measured with the Numeric Rating Scale (NRS) at 4 weeks, 3 months and 1 year postoperatively Scale range: 0-10 0 = no pain 10 = worst imaginable pain Interpretation: Higher scores indicate more severe pain (worse outcome)	4 weeks, 3 months and 1 year postoperatively
Health-related quality of life	EuroQoL 5D (EQ5D-5L) for measuring health-related quality of life at 4 weeks, 3 months and 1 year postoperatively Index score range: From <0 (health states worse than death) to 1.0 (full health) Interpretation: Higher scores indicate better health-related quality of life	4 weeks, 3 months and 1 year postoperatively
Work productivity	Work productivity measured with the IMTA Productivity Cost Questionnaire (iPCQ) at 4 weeks, 3 months and 1 year postoperatively Scale: Multiple items assessing absenteeism and presenteeism Range: Item-specific (continuous variables expressed in days or hours) Interpretation: Higher productivity loss indicates a worse outcome	4 weeks, 3 months and 1 year postoperatively
Analgesics use	Analgesics use, quantified by the Medication Quantification Scale (MQS) at 4 weeks, 3 months and 1 year postoperatively Scale range: 0 to no predefined maximum (higher scores reflect greater medication burden) Interpretation: Higher scores indicate greater analgesic use (worse outcome)	4 weeks, 3 months and 1 year postoperatively
Kinesiophobia	Kinesiophobia measured by the Tampa Scale for Kinesiophobia (TSK) at 4 weeks, 3 months and 1 year postoperatively Scale range: 17-68 Interpretation: Higher scores indicate greater fear of movement (worse outcome)	4 weeks, 3 months and 1 year postoperatively
Pain catastrophizing	Pain catastrophizing measured by the Pain Catastrophizing Scale (PCS) at 4 weeks, 3 months and 1 year postoperatively Scale range: 0-52 Interpretation: Higher scores indicate greater pain catastrophizing (worse outcome)	4 weeks, 3 months and 1 year postoperatively

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Federal Knowledge Centre (KCE)

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: December 17, 2025
• First Posted (Actual): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; Return to work; radicular pain; Lumbar radiculopathy; Cluster RCT; Case manager
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Radiculopathy
• Other Study ID Numbers: S68181; KCE23-1473 (Other Grant/Funding Number: Belgian Health Care Knowledge Centre Trials Program (KCE trials))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared, including demographic variables, surgical characteristics, pain scores, disability measures, quality-of-life outcomes, work-status variables, and follow-up assessments. No identifying data will be shared. Data will be provided in a fully anonymized format in accordance with GDPR and institutional data protection standards.
• IPD Sharing Time Frame: IPD and supporting documents will become available 12 months after publication of the primary results of the trial. Data will remain available for a minimum of 5 years after publication. Requests can be submitted at any time within this window. After 5 years, continued availability will depend on data storage capacity and institutional policies.
• IPD Sharing Access Criteria: Access will be granted to qualified researchers with a methodologically sound proposal aimed at scientific replication or secondary analyses related to postoperative rehabilitation or return-to-work after lumbar surgery. Requests must include a study protocol and data management plan. Following review and approval by the study team, data will be shared through a secure institutional platform under a data-sharing agreement. Only fully anonymized datasets and approved supporting documents will be accessible.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No