An Evidence-based Rehabilitation Pathway for Patients Undergoing Surgery for Lumbar Radicular Pain to Promote Return to Work: a Cluster Randomized Trial Comparison With Usual Care.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 480
- 试验地点
- 32
- 主要终点
- Time to Return To Work (RTW)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Control: usual care
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
Intervention: R³ 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.
干预措施: R³ Rehabilitation Pathway (Other)
结局指标
主要结局
Time to Return To Work (RTW)
时间窗: 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
Time to Return To Work (RTW)
时间窗: 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
次要结局
- Patient-centered functional status(4 weeks, 3 months and 1 year postoperatively)
- Pain catastrophizing(4 weeks, 3 months and 1 year postoperatively)
- Disability(3 months and 12 months postoperatively)
- Percentage of patients returned to work(4 weeks, 3 months and 1 year postoperatively)
- Patient-centered functional status(4 weeks, 3 months and 1 year postoperatively)
- Back pain(4 weeks, 3 months and 1 year postoperatively)
- Leg pain(4 weeks, 3 months and 1 year postoperatively)
- Health-related quality of life(4 weeks, 3 months and 1 year postoperatively)
- Work productivity(4 weeks, 3 months and 1 year postoperatively)
- Analgesics use(4 weeks, 3 months and 1 year postoperatively)
- Kinesiophobia(4 weeks, 3 months and 1 year postoperatively)
- Pain catastrophizing(4 weeks, 3 months and 1 year postoperatively)