Lumbar Radiculopathy, Radicular Low Back Pain
Conditions
Keywords
Lumbar radiculopathy, Return to work, Case manager, Cluster RCT, Rehabilitation, radicular pain
Brief 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. 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
OTHERR³ 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.
Sponsors
Universitaire Ziekenhuizen KU Leuven
Federal Knowledge Centre (KCE)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return To Work (RTW) | 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
| Measure | Time frame | Description |
|---|---|---|
| Disability | 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) |
| Percentage of patients returned to work | 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 |
| Patient-centered functional status | 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 |
| Back pain | 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) |
| Leg pain | 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) |
| Health-related quality of life | 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 |
| Work productivity | 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 |
| Analgesics use | 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) |
| Kinesiophobia | 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) |
| Pain catastrophizing | 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) |
Countries
Belgium
Contacts
CONTACTOlivier Nachtergaele, MD
Outcome results
None listed