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| ID | Type | Description | Link |
|---|---|---|---|
| KCE23-1473 | Other Grant/Funding Number | Belgian Health Care Knowledge Centre Trials Program (KCE trials) |
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| Name | Class |
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| Federal Knowledge Centre (KCE) | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: R³ Rehabilitation Pathway | Experimental | 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. |
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| Control: usual care | No Intervention | Usual care, i.e. usual, variable rehabilitation care, which may vary between and within hospitals and may include no rehabilitation, monodisciplinary or multidisciplinary care, with highly variable advice to the patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Assessed from surgery to 15 months postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months and 12 months postoperatively |
| Percentage of patients returned to work |
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Inclusion Criteria:
Exclusion Criteria:
Patients are not eligible for the trial in case of any of the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier Nachtergaele, MD | Contact | +32 16 34 02 72 | olivier.nachtergaele@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZAS | Not yet recruiting | Antwerp | Belgium |
De-identified individual participant data (IPD) underlying the primary and secondary outcomes will be shared, including demographic variables, surgical characteristics, pain scores, disability measures, quality-of-life outcomes, work-status variables, and follow-up assessments. No identifying data will be shared. Data will be provided in a fully anonymized format in accordance with GDPR and institutional data protection standards.
IPD and supporting documents will become available 12 months after publication of the primary results of the trial. Data will remain available for a minimum of 5 years after publication. Requests can be submitted at any time within this window. After 5 years, continued availability will depend on data storage capacity and institutional policies.
Access will be granted to qualified researchers with a methodologically sound proposal aimed at scientific replication or secondary analyses related to postoperative rehabilitation or return-to-work after lumbar surgery. Requests must include a study protocol and data management plan. Following review and approval by the study team, data will be shared through a secure institutional platform under a data-sharing agreement. Only fully anonymized datasets and approved supporting documents will be accessible.
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Cluster randomized controlled trial
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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 |
| 4 weeks, 3 months and 1 year postoperatively |
| 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 | 4 weeks, 3 months and 1 year postoperatively |
| 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) | 4 weeks, 3 months and 1 year postoperatively |
| Leg pain | 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) | 4 weeks, 3 months and 1 year postoperatively |
| Health-related quality of life | 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 | 4 weeks, 3 months and 1 year postoperatively |
| Work productivity | 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 | 4 weeks, 3 months and 1 year postoperatively |
| Analgesics use | 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) | 4 weeks, 3 months and 1 year postoperatively |
| Kinesiophobia | 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) | 4 weeks, 3 months and 1 year postoperatively |
| Pain catastrophizing | 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) | 4 weeks, 3 months and 1 year postoperatively |
| AZ Sint Jan Brugge | Recruiting | Bruges | Belgium |
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| UZ Brussel | Not yet recruiting | Brussels | Belgium |
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| Grand Hôpital de Charleroi | Not yet recruiting | Charleroi | Belgium |
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| Ziekenhuis Geel | Not yet recruiting | Geel | Belgium |
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| ZOL Genk | Recruiting | Genk | Belgium |
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| Jessa Ziekenhuis | Not yet recruiting | Hasselt | Belgium |
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| AZ Herentals | Not yet recruiting | Herentals | Belgium |
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| Jan Yperman ziekenhuis | Not yet recruiting | Ieper | Belgium |
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| AZ Groeninge Kortrijk | Not yet recruiting | Kortrijk | Belgium |
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| UZ Leuven | Recruiting | Leuven | Belgium |
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| Heilig Hart Lier | Recruiting | Lier | Belgium |
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| AZ Sint Maarten Mechelen | Not yet recruiting | Mechelen | Belgium |
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| CSPO | Not yet recruiting | Ottignies | Belgium |
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| AZ Delta Roeselare | Not yet recruiting | Roeselare | Belgium |
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| Centre Hospitalier de Wallonie Picarde | Not yet recruiting | Tournai | Belgium |
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| ID | Term |
|---|---|
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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