R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
R³ Rehabilitation Pathway
Other interventionA 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.
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: Intervention: R³ Rehabilitation PathwayExperimental treatment 1 intervention
Group B: Control: usual careNo intervention 0 interventions
Trial outcomes
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
Time frame
Assessed from surgery to 15 months postoperativelySecondary outcomes
1
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)
Time frame
3 months and 12 months postoperatively2
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
Time frame
4 weeks, 3 months and 1 year postoperatively3
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
Time frame
4 weeks, 3 months and 1 year postoperatively4
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)
Time frame
4 weeks, 3 months and 1 year postoperativelySponsors and contacts
Click on the lead sponsor to view all of their trials.
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
Federal Knowledge Centre (KCE)
Collaborator
Source ClinicalTrials.gov