Lumbar RadiculopathyR³NCT07313566
R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
A study testing R³ Rehabilitation Pathway in people with Lumbar Radiculopathy and Radicular Low Back Pain, run by Universitaire Ziekenhuizen KU Leuven at 16 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy, Radicular Low Back Pain
- What is being tested?
- R³ Rehabilitation Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 16 sitesBelgium
- Study dates
- 16 Mar 2026to May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Belgium16 sites, 16 recruiting
- Not yet recruiting
ZAS
Antwerp
Kris De Smedt, MD, +323 443 37 71, kris.desmedt@zas.be
- Recruiting
AZ Sint Jan Brugge
Bruges
Evelyne Linden, MD, +32 (0)50 36 50 30, evelyne.linden@azsintjan.be
- Not yet recruiting
UZ Brussel
Brussels
Marc Schiltz, MD, PhD, +32 (0)2 477 77 12, marc.schiltz@uzbrussel.be
- Not yet recruiting
Grand Hôpital de Charleroi
Charleroi
Maxime Valet, MD, +32 71 10 69 43, maxime.valet@ghdc.be
- Not yet recruiting
Ziekenhuis Geel
Geel
Arne Heyns, MD, +3214 57 70 35, arne.heyns@ziekenhuisgeel.be
- Recruiting
ZOL Genk
Genk
Christophe Oosterbos, MD, +3289326043, christophe.oosterbos@zol.be
- Not yet recruiting
Jessa Ziekenhuis
Hasselt
Kristof Kempeneers, MD, +3211338812, kristof.kempeneers@jessazh.be
- Not yet recruiting
AZ Herentals
Herentals
Maarten Rombauts, MD, +3214 24 61 60, maarten.rombauts@azherentals.be
- Not yet recruiting
Jan Yperman ziekenhuis
Ieper
Kristof Vermeersch, MD, +3257 35 73 80, kristof.vermeersch@yperman.net
- Not yet recruiting
AZ Groeninge Kortrijk
Kortrijk
Michael Bultheel, MD, +3256 63 32 00, michael.bultheel@azgroeninge.be
- Recruiting
UZ Leuven
Leuven
Olivier Nachtergaele, MD, olivier.nachtergaele@uzleuven.be
- Recruiting
Heilig Hart Lier
Lier
Michael Schreurs, MD, +3234912209, Michael.Schreurs@heilighartlier.be
- Not yet recruiting
AZ Sint Maarten Mechelen
Mechelen
Pieter Jan Van Dyck-Lippens, MD, +3215 89 37 32, pieterjan.van.dyck-lippens@emmaus.be
- Not yet recruiting
CSPO
Ottignies
Luc Barras, MD, +3210437383, luc.barras@cspo.be
- Not yet recruiting
AZ Delta Roeselare
Roeselare
Jeroen Van Lerbeirghe, MD, +32 (0)51 23 74 17, jeroen.vanlerbeirghe@azdelta.be
- Not yet recruiting
Centre Hospitalier de Wallonie Picarde
Tournai
Jordan Assaker, MD, +32 (0)69331349, jordan.assaker@chwapi.be
About this study
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.
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
- Being tested
- R³ Rehabilitation Pathway
- Keywords
- Lumbar radiculopathy, Return to work, Case manager, Cluster RCT, Rehabilitation, radicular pain
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
R³ Rehabilitation PathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention: R³ Rehabilitation Pathway | Experimental | 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. Receives: Other: R³ Rehabilitation Pathway |
| Control: usual care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Assessed from surgery to 15 months postoperatively
Secondary outcomes (10)
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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 weeks, 3 months and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start16 Mar 2026
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Knowledge Centre (KCE)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313566
- Sponsor's protocol ID
- S68181
- Other IDs
- KCE23-1473
- Acronym
- R³
- Status last verified
- Apr 2026
- First submitted
- 24 Nov 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.