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临床试验/NCT02517762
NCT02517762已完成不适用

Labour Triggered Acute Low Back Pain: Origin, Mechanisms, Causes of Pain, Evaluation of Treatment and Followup

Göteborg University0 个研究点目标入组 99 人开始时间: 2005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
99
主要终点
Physical activity

研究概览

简要总结

The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. Thereafter, the included patients are allocated either to the advice to stay as active as possible in spite of the pain or to adjust their activity to the pain. Pain intensity and physical activity are followed prospectively over seven days using a diary and a pedometer.

详细描述

The purpose of this study is to investigate acute low back pain, its origin, mechanisms, the cause of pain, evaluation of treatments and development. Employees from a large local manufacturing company are sent for a complete orthopedic and pain evaluation immediately after onset of acute low back pain. The patients go through x-ray examinations, physical examinations, they complete a battery of questionnaires covering history of acute low back pain, lifestyle characteristics, work place factors, psychosocial factors, and indicate pain intensity and pain locations. Thereafter the patients are randomly allocated to one of two treatment advices: stay active as much as possible in spite of pain or adjust the activity to the pain. During seven days after the medical examination the patients wear a pedometer attached to the waist and annotate the number of steps and pain intensity, pain location and pain-related disability in a diary. A numeric graphic scale is used for pain intensity. Work absenteeism and sick leave due to the current acute back pain is collected from the company records. Immediate inclusion after pain onset is facilitated with continuous communication with the manufactory company. Physical activity and pain development over the seven days is investigated statistically using linear mixed models for repeated measures.

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
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Severe acute low back pain, duration within 24h after onset, pain exceeds 50mm on the visual analog scale (VAS)

排除标准

  • •Sick-leave because of low back pain or in spine in the last month

研究组 & 干预措施

Adjust activity

Experimental

Receive the advice by the physician to adjust the activity according to the pain, i.e. to avoid activities, movements or positions that cause or worsen the pain

干预措施: Physical activity (Behavioral)

Stay active

Experimental

Receive the advice by the physician to stay as active as possible in spite of the pain experienced

干预措施: Physical activity (Behavioral)

结局指标

主要结局

Physical activity

时间窗: 7 days

The patients wear a pedometer attached to the hip and annotate the number of daily steps each day in a diary

Acute low back pain

时间窗: 7 days

Pain intensity is assessed from a numerical graphic scale, ranging from 0 (no pain) to 10 (pain as bad as it can be); the patients complete the scale each day in a diary

次要结局

  • Work absenteeism and sick leave(7 days)

研究者

发起方
Göteborg University
申办方类型
Other
责任方
Sponsor

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