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临床试验/CTRI/2024/12/077598
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

Manipal Academy of Higher Education1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2024年12月15日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Jomi John

Manipal Academy of Higher Education

研究点 (1)

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