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.
2 other identifiers
interventional
480
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 24, 2025
CompletedFirst Posted
Study publicly available on registry
January 2, 2026
CompletedStudy Start
First participant enrolled
March 16, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
May 5, 2026
April 1, 2026
2.1 years
November 24, 2025
April 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Disability
3 months and 12 months postoperatively
Percentage of patients returned to work
4 weeks, 3 months and 1 year postoperatively
Patient-centered functional status
4 weeks, 3 months and 1 year postoperatively
Back pain
4 weeks, 3 months and 1 year postoperatively
Leg pain
4 weeks, 3 months and 1 year postoperatively
- +5 more secondary outcomes
Study Arms (2)
Intervention: R³ Rehabilitation Pathway
EXPERIMENTALA 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
NO INTERVENTIONUsual 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2025
First Posted
January 2, 2026
Study Start
March 16, 2026
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- 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.
- 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.
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.