Menu
Recruiting NCT07313566

R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

No phase Interventional Lumbar Radiculopathy Radicular Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: R³ Rehabilitation Pathway.
Who it may be relevant to
Registry conditions: Lumbar Radiculopathy, Radicular Low Back Pain. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Time to Return To Work (RTW) [Time frame: Assessed from surgery to 15 months postoperatively]
Secondary outcome measures (10)
  • Disability [Time frame: 3 months and 12 months postoperatively]
  • Percentage of patients returned to work [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Patient-centered functional status [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Back pain [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Leg pain [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Health-related quality of life [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Work productivity [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Analgesics use [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Kinesiophobia [Time frame: 4 weeks, 3 months and 1 year postoperatively]
  • Pain catastrophizing [Time frame: 4 weeks, 3 months and 1 year postoperatively]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 16 centers
  • ZAS — Antwerp
  • AZ Sint Jan Brugge — Bruges
  • UZ Brussel — Brussels
  • Grand Hôpital de Charleroi — Charleroi
  • Ziekenhuis Geel — Geel
  • ZOL Genk — Genk
  • Jessa Ziekenhuis — Hasselt
  • AZ Herentals — Herentals
  • … and 8 more centers

Identifiers

NCT: NCT07313566 · S68181 · KCE23-1473

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗