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临床试验/NCT01830751
NCT01830751已完成不适用

Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain

Liberty Mutual Research Institute for Safety1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2013年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
106
试验地点
1
主要终点
Pain Score (numerical rating scale 0-10)

研究概览

简要总结

The purpose of the proposed study is to test the effect of an intervention technique that reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and functional impairment in individuals with chronic or recurrent non-specific low back pain (LBP). The intervention is a self-administered and requires no medical intervention or drugs. The technique referred to as the restrained sitting treatment (RST), involves training in minimizing forward bending of the trunk immediately upon rising. The technique builds upon a previous randomized controlled study conducted and published by members of the research team. The underlying premise of RST exploits the natural diurnal pattern as the intervertebral discs (people are tallest when they first wake up). The discs are fully hydrated upon rising, disc internal hydrostatic pressures and external forces acting on surrounding soft tissues are greatest at this time, and these pressures and forces can increase significantly with trunk flexion. The RST technique utilizes a back support used in sitting during the first hour upon rising to minimize trunk flexion during this critical period as the intervertebral discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that there are no significant difference in outcome (LBP, work or social function/disability) between groups performing RST, the experimental group performing RST upon rising, the control group performing prior to going to bed.

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, Investigator)

入排标准

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

入选标准

  • •Clinical diagnosis of chronic or recurrent low back pain
  • •Six month or longer history of non-specific LBP
  • •Minimum 90 days in pain in the last six months
  • •Average pain score of past month ≥3 on a 0-10 numerical rating scale

排除标准

  • •Red flags (tumor, metabolic diseases, Rheumatoid arthritis, osteoporosis, prolonged steroid use, pregnancy, back surgery)
  • •Evidence of nerve root compression (pain reproduction with SLR>45º, weakness of major lower extremity muscle group, decreased deep tendon reflexes at knee or ankle, decreased sensation to pinprick)
  • •Acute trauma to low back

研究组 & 干预措施

Limit trunk flexion before going to bed

Sham Comparator

Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour.

干预措施: Restrained Sitting Treatment (Other)

Limit trunk flexion upon rising

Experimental

Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour.

干预措施: Restrained Sitting Treatment (Other)

结局指标

主要结局

Pain Score (numerical rating scale 0-10)

时间窗: Baseline and 3 months (end of intervention phase)

Change in mean number of days reporting disability from beginning to end of intervention phase

次要结局

  • Functional limitation in work(Baseline and 3 months (end of intervention phase))
  • Medication taken for back pain(Baseline and 3 months (end of intervention phase))

研究者

发起方
Liberty Mutual Research Institute for Safety
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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