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临床试验/NCT01788111
NCT01788111已完成不适用

Occurrence, Diagnosis and Treatment of Neck and Back Pain in Helicopter Pilots.

Helse Stavanger HF1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
325
试验地点
1
主要终点
Multifidus muscle fat infiltration (% of muscle volume).

研究概览

简要总结

The purpose of this project is to investigate the occurrence of neck and back pain in a population of commercial helicopter pilots, and investigate factors related to the profession that can cause these problems. The project has a biological approach assessing the supporting and stabilizing muscles (multifidus) in pilots with chronic back and neck ailments. Pilots with low back problems are invited to a controlled intervention trial to investigate whether one can achieve improved spinal health with a rigid training régime. Primary trial outcome is improved neck and back multifidus muscles pathology and function as assessed by the extent of fat infiltration -as visualized on MRI - and the volume and ability of the lumbar multifidus muscles to contract as shown with ultrasound. The perceived effect on spinal health with sick leave frequency is also evaluated.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Pilots must experience low back pain in at least 1 of 3 flights or
  • Pilots must have at least 2 episodes of low back pain of at least 24 hours duration over the last 12 months. Each episode is separated with at least one painfree month before and after each episode, or
  • Pilots may have had more than 3 sick leaves due to low back pain over the last 5 years

排除标准

  • contraindications for physical training/activity

结局指标

主要结局

Multifidus muscle fat infiltration (% of muscle volume).

时间窗: one year

Primary trial outcome is improved neck and back multifidus muscles pathology and function as assessed by the extent of fat infiltration as visualized on MRI (% of muscle volume).Change from baseline at 12 months.

次要结局

  • Lumbar multifidus muscles contractability.(Two years)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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