CTRI/2024/12/077598招募中不适用
Effect of Biopsychosocial Model of rehabilitation on Functional disability and Pain in patients after Robotic Assisted Lumbar Fusion Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Oswestry Disability Index and Visual Analogue Scale
研究概览
简要总结
The biopsychosocial model demonstrates a positive impact on musculoskeletal conditions. Research investigating its application in post-operative management has documented positive effects on catastrophizing pain management and functional outcomes.However, a knowledge gap remains in assessing the rehabilitation impact following robotic-assisted lumbar fusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing index single-level or two-level fusion between the ages of 18 and 65 from L1 to S
- •Patient selected for lumbar fusion with decompression A primary diagnosis of spinal stenosis, spondylosis, degenerative or isthmic spondylolisthesis or degenerative disc disease.
排除标准
- •Patients diagnosed with inflammatory conditions like Rheumatoid arthritis and Ankylosing spondylitis Severe cardiorespiratory or patients with neurological deficits (ASIA C and above) Severe psychiatric/psychological disorder Alcohol abuse Immediate complications after surgery (infection) Degenerative or idiopathic scoliosis History of malignancy in spine Poor post-operative General health condition Spinal fracture Worsening of existing or the appearance of new symptoms.
结局指标
主要结局
Oswestry Disability Index and Visual Analogue Scale
时间窗: At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery and twelve weeks after surgery.
次要结局
- Timed Up & Go Test(At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery & twelve weeks after surgery.)
- Pain catastrophizing Scale(At Baseline assessment (Before the surgery), two weeks after surgery, four weeks after surgery & twelve weeks after surgery.)
- SF 36 questionnaire(At Baseline Assessment (Before surgery) & twelve weeks after surgery)
研究者
Jomi John
Manipal Academy of Higher Education
研究点 (1)
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