R³ rehabilitation pathway versus usual care after lumbar nerve-root surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

R³ is a multicentre cluster randomized trial in which hospitals are randomized to implement an evidence-based, person-centred rehabilitation pathway or continue usual care. The pathway includes structured pre-, peri-, and postoperative rehabilitation, early postoperative mobilization, case management, early return-to-work guidance, and patient empowerment. The trial enrolls employed adults with radicular lumbar pain scheduled for (micro)discectomy, decompression, or one- to two-level fusion and measures time to return to work as the primary outcome. Multiple Belgian university and regional hospitals participate to compare the pathway against routine postoperative management.

Why it matters

Who can join: the full rules

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

Where it's running

• AZ Sint Jan Brugge
  Bruges, Belgium Recruiting
• ZOL Genk
  Genk, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Heilig Hart Lier
  Lier, Belgium Recruiting
• Zas
  Antwerp, Belgium Not yet recruiting
• UZ Brussel
  Brussels, Belgium Not yet recruiting

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Mulligan leg raise vs spinal mobilization with leg movement for lumbar radiculopathy

  This trial tests whether Mulligan leg raise traction or spinal mobilization with leg movement helps people with lumbar radiculopathy feel better.

  Recruiting Foundation University Islamabad · Islamabad, Punjab Province · NCT07887685

• TECAR therapy added to physical therapy for chronic discogenic sciatica

  This study tests whether adding TECAR therapy to a standard physical therapy program helps reduce pain and improve function in adults with chronic discogenic sciatica.

  Recruiting Cairo University · Giza · NCT07841405

• Pharmacopuncture vs. physical therapy for chronic lumbar radiculopathy

  This pragmatic trial tests whether pharmacopuncture can help people with chronic lumbar radiculopathy as well as or better than physical therapy.

  Recruiting Jaseng Medical Foundation · Bucheon-si, Gyeonggi-do and 3 other locations · NCT07832318

• Femoral Stretch Test in L2-L4 Lumbar Radiculopathy

  This study tests how well the femoral stretch test detects nerve root compression in people with L2-L4 radiculopathy who are having a targeted epidural injection as part of their care.

  Recruiting Marmara University · Istanbul, Pendik · NCT07799142

• Trans-spinal Electromagnetic Neuromodulation added to physical therapy for discogenic L5-S1 radiculopathy

  This study tests whether adding trans-spinal electromagnetic neuromodulation to standard physical therapy helps people with unilateral disc-related lower back nerve pain.

  Recruiting Cairo University · Giza · NCT07743424

• Effect of Mulligan Bent Leg Raise vs. Spinal Mobilization With Leg Movement for Lumbar Radiculopathy

  A small study tests two manual therapy techniques to see which better eases leg pain and improves function in adults with lumbar radiculopathy.

  Recruiting Riphah International University · Lahore, Punjab Province · NCT07726823

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.