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NCT Number: NCT07313566

R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

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.

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Key information

Conditions

Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radicular Low Back Pain Radiculopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ZAS, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

R³ Rehabilitation Pathway

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.

Primary outcomes

  1. Time to Return To Work (RTW)

    Time frame: Assessed from surgery to 15 months postoperatively

    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

Secondary outcomes

  1. Disability

    Time frame: 3 months and 12 months postoperatively

    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)

  2. Percentage of patients returned to work

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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

  3. Patient-centered functional status

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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. Back pain

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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)

  5. Leg pain

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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)

  6. Health-related quality of life

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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

  7. Work productivity

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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

  8. Analgesics use

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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)

  9. Kinesiophobia

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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)

  10. Pain catastrophizing

    Time frame: 4 weeks, 3 months and 1 year postoperatively

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier Nachtergaele, MD

CONTACT

[email protected]

+32 16 34 02 72

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Federal Knowledge Centre (KCE)

Registry information

Official study 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.

Acronym: R³

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 2, 2026
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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