A Randomized Controlled Trial of Multimodal Rehabilitation Versus Standard Care on Adjacent Segment Degeneration in Frail Elderly Patients Undergoing Short-Segment Lumbar Fusion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 3
- 主要终点
- Time to Adjacent Segment Degeneration (ASDeg)
研究概览
简要总结
This is a prospective, randomized controlled trial aimed at evaluating whether a structured multimodal rehabilitation program can delay or reduce the occurrence of adjacent segment degeneration (ASDeg) in frail elderly patients after short-segment lumbar fusion surgery.
详细描述
- Rationale and Scientific Background Adjacent segment degeneration (ASDeg) represents a major determinant of long-term clinical success after lumbar fusion. In frail older adults (≥75 years, Fried phenotype), the risk is theorized to be amplified due to age-related sarcopenia, osteopenia, diminished healing capacity, and compensatory biomechanical overload. While Enhanced Recovery After Surgery (ERAS) protocols address acute perioperative stress, they do not provide a targeted, long-term strategy to modify the underlying biological and biomechanical progression toward ASD. This trial is grounded on the hypothesis that a structured, multimodal rehabilitation program, initiated after the initial bone-soft tissue healing phase (12 weeks), can enhance paraspinal muscular endurance, improve global sagittal alignment, increase bone density, and mitigate systemic frailty. This multisystem approach aims to decelerate the degenerative cascade at adjacent segments compared to standard care alone.
- Intervention Design and Theoretical Framework Timing Rationale: The intervention commencement at 12 weeks postoperatively is deliberately chosen to avoid interference with initial osseous fusion and wound healing, while capitalizing on the phase of maximal functional plasticity and patient engagement in recovery.
Multimodal Components: The program integrates three evidence-based components supervised by a physiotherapist:
Progressive Resistance & Stabilization Training: Targets deep spinal stabilizers and global movers to restore functional strength and reduce segmental strain.
Neuromotor & Balance Re-education: Addresses age-related proprioceptive decline to improve movement efficiency and reduce fall risk.
Pain Neuroscience Education & Activity Pacing: Aims to modify maladaptive pain behaviors and fear-avoidance beliefs, promoting sustained engagement.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 75 years.
- •Classified as "frail" according to the Fried frailty phenotype.
- •Scheduled for first-time, posterior short-segment (1-2 levels) lumbar instrumented fusion surgery.
- •Willing and able to provide written informed consent and complete the 2-year follow-up.
排除标准
- •History of previous lumbar spine surgery.
- •Lumbar pathology due to tumor, trauma, infection, or congenital deformity.
- •Comorbidities with a severe impact on prognosis or ability to participate in rehabilitation (e.g., severe cardiopulmonary disease, advanced dementia).
研究组 & 干预措施
Routine Care Group
All patients in this group undergo standard Enhanced Recovery After Surgery (ERAS) protocols tailored for frail individuals, which encompass optimization of nutrition, pain management, early mobilization, and other evidence-based perioperative measures.
Multimodal Rehabilitation Group
This group receives a supervised, structured, and progressive multimodal rehabilitation program in addition to the standard perioperative Enhanced Recovery After Surgery (ERAS) care and initial home exercise guidance.
干预措施: Postoperative Multimodal Rehabilitation Program (Behavioral)
结局指标
主要结局
Time to Adjacent Segment Degeneration (ASDeg)
时间窗: From surgery date up to 2 years postoperatively (730 days).
The number of days from the surgery date to the radiographic diagnosis of ASDeg. For participants who do not develop ASD during the study, the data will be censored at 730 days (2 years postoperatively). This measure is used to compare the intervention and control groups.
次要结局
- Comprehensive Complication Index(Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.)
- Oswestry disability index(Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.)
- Leg Pain Visual Analog Scale (VAS) Score(Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.)
- Japanese Orthopaedic Association (JOA) Score for Low Back Pain(Preoperative; immediately postoperative; and at 12, 24, 48, 60, 72, and 96 weeks postoperatively.)