R³ Rehab Pathway Versus Usual Care After Lumbar Radicular Surgery

Universitaire Ziekenhuizen KU Leuven480 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

480

Conditions

Lumbar Radiculopathy Radicular Low Back Pain

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

ZAS

Antwerp, Belgium

NOT_YET_RECRUITING

AZ Sint Jan Brugge

Bruges, Belgium

RECRUITING

UZ Brussel

Brussels, Belgium

NOT_YET_RECRUITING

Grand Hôpital de Charleroi

Charleroi, Belgium

NOT_YET_RECRUITING

Ziekenhuis Geel

Geel, Belgium

NOT_YET_RECRUITING

ZOL Genk

Genk, Belgium

RECRUITING

Jessa Ziekenhuis

Hasselt, Belgium

NOT_YET_RECRUITING

AZ Herentals

Herentals, Belgium

NOT_YET_RECRUITING

Jan Yperman ziekenhuis

Ieper, Belgium

NOT_YET_RECRUITING

AZ Groeninge Kortrijk

Kortrijk, Belgium

NOT_YET_RECRUITING

...and 6 more locations

Outcomes

Primary Outcomes

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 postoperatively

Secondary Outcomes

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 postoperatively

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