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临床试验/NCT02547324
NCT02547324终止不适用

Slump Sitting X-ray of the Lumbar Spine Is Better Than Conventional Flexion

National University Hospital, Singapore0 个研究点目标入组 60 人开始时间: 2014年5月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
60
主要终点
Global lumbar spine flexion range of motion

研究概览

简要总结

This is a prospective, single-blinded, randomized-controlled study comparing a new method (slump-sitting) with the conventional method (forward erect bending) of performing lumbar spine flexion X-rays.

详细描述

Power calculation was performed based on preliminary pilot results using a clinically set difference of 10 degrees (SD 15 degrees) change in mean global lumbar spine flexion between sitting and standing postures. An estimated sample population of 100 patients was deemed necessary for this study to fulfill a statistical power of 90% and a two-sided 5% significance level.

Block randomization of every 4 subjects was performed at the beginning of the study to ensure equal numbers of subjects in both study arms for comparison and these results were concealed in envelopes.

During the clinical consult, history taking was performed as per a usual clinic visit. Specific patient's details including age, occupation, presence and severity of back pain, presence and severity of leg pain, and neurological symptoms were documented. Physical examination was performed accordingly and parameters such as clinical range of motion of the lumbar spine, neurological signs and provocative tests were recorded for later analysis.

For the flexion radiographs, both the new and conventional methods were performed on each patient. These pictures were made into charts and visually displayed. They serve as instructional manuals for patients during the radioimaging process, which are again reinforced with verbal instructions from the on-duty radiographers.

Both images were done with the X-ray beam projected from the patients's left and at a distance of 100cm from the patient. The central beam was directed at the estimated centre of L3, with T11 vertebral body and mid-body of the sacrum serving as superior and inferior limits respectively. A single extension view of the lumbar spine was also performed after these flexion views. All radiographs were stored on Digital Imaging and Communications in Medicine (DICOM) format and viewed with Centricity Enterprise Web V3.0 (8.0.1400.128) for assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Investigator)

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients above 45 years of age;
  • With mechanical low back pain,
  • With spondylolisthesis
  • Physically able to position themselves correctly for both methods of X-rays

排除标准

  • Previous spinal interventions
  • Suspected findings for spinal malignancies, spinal trauma, and inflammatory spinal diseases
  • Pregnant women

结局指标

主要结局

Global lumbar spine flexion range of motion

时间窗: Day 1 (no follow-up, outcome assessed immediately)

Change in mean global lumbar spine flexion between sitting and standing postures

次要结局

  • Segmental lumbar spine flexion range of motion(Day 1 (no follow-up, outcome assessed immediately))
  • Segmental translational changes during lumbar spine flexion(Day 1 (no follow-up, outcome assessed immediately))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Orthosurgery

Dr. Hey Hwee Weng Dennis

National University Hospital, Singapore

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