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临床试验/NCT01465698
NCT01465698已完成不适用

Effectiveness and Financial Feasibility of Neuromuscular Exercise and Counselling Interventions on Pain, Movement Dysfunction, and Fear-avoidance Behaviour in Female Nurses With Non-specific Low Back Pain

UKK Institute1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2011年11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
219
试验地点
1
主要终点
Intensity of LBP for past month assessed by Visual Analog Scale

研究概览

简要总结

NURSE-RCT is a randomized controlled trial which aims at prevention of evolution of chronic low back pain (LBP) and related disability in female nurses.

The study investigates the effectiveness and financial feasibility of six months neuromuscular training and counselling, and their combination on LBP, movement dysfunction and fear-avoidance behaviour.

The target for neuromuscular training is to reduce movement dysfunction and motor control impairments, caused by trauma and subfailure injuries of spinal ligaments. Training aims at enhancement of motor control of lumbar neutral zone in different positions and movements, balance, coordination, trunk muscle endurance and leg strength.

The target for counselling is change in attitudes and behaviour, which help to reduce the fear of pain and encourage to physical activity and other physical tasks.

The hypothesis is that together neuromuscular exercise and counselling have a stronger influence on LBP, movement dysfunction and fear-avoidance behaviour than either used alone.

Assessments of effectiveness will be conducted after six, 12, and 24 months of the beginning of interventions.

详细描述

Musculoskeletal disorders are the main reason for work absenteeism and early retirement of nursing stuff, low back pain (LBP) being the leading cause. When compared to other communal staff in Finland, disability pensions are granted earlier to nursing stuff, the average age being 56 years. NURSE-RCT is a multidisciplinary study combining the most recent biomechanical and behavioral theories aimed to prevent evolution of chronic LBP.

NURSE-study is a randomized controlled trial aiming at prevention of chronic LBP and related functional disability. Volunteers, female nurses (n~1200) from wards with bed patients of two geriatric hospitals and the university central hospital in Tampere, Finland will be invited to participate in the study. Each participant (n=160) will be randomized into one of the four study groups after the eligibility has been determined. A method of sequentially numbered sealed envelopes will be used to assign participants into study groups.

The main target for exercise intervention is to restore impairments in movement control. First, the participants need to learn the proper technique of each exercise, second to achieve movement control of lumbar neutral zone in each exercise, and finally to increase the challenge of exercises for balance, coordination, muscular endurance and strength. Target dose for exercise is twice a week, 60 minutes per session for six months.

The objective of counseling is to change participants' understanding of LBP towards less fearful and negative beliefs, and to provide encouragement for usual daily activities, including physical activity. Advice on nursing tasks that are strenuous for low back is aimed to improve awareness of injury risk and provide examples of proper postures and movements. Target dose for counseling is 10 sessions lasting for 45 minutes. Interventions will take place in facilities close to participants' work sites.

The financial feasibility of the effects of the interventions is calculated by using the Potential Model,[www.miljodata.se\],which was created to calculate the financial feasibility of work health related measures. It differs from typical health economic cost-benefit analyses in the sense that it is aimed at simulating the economic consequences of an investment from a business point of view. In addition to the immediate real losses and sickness absences, the indirect financial consequences like effects on over time work are taken into account.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •woman aged 40 to 55
  • •working at one's current nursing job at least for 12 months
  • •intensity of LBP on Visual Analog Scale (VAS) has been greater than 20mm (scale 0-100) during the last month

排除标准

  • •serious former back injury (fracture, surgery, discus prolapse)
  • •chronic low back symptoms i.e. time when last experienced no low back pain is longer than six months
  • •pregnant or recent delivery (<12months)
  • •general health problems prevent moderate exercise
  • •body mass index >35

研究组 & 干预措施

Exercise

Experimental

干预措施: Exercise (Behavioral)

Counseling

Experimental

干预措施: Counseling (Behavioral)

Exercise and counseling

Experimental

干预措施: Exercise and counseling (Behavioral)

Control group

Other

Participants in the control group only participate in study measurements.

干预措施: Control group (Other)

结局指标

主要结局

Intensity of LBP for past month assessed by Visual Analog Scale

时间窗: Baseline, 6, 12 and 24 months follow-up

Changes in the intensity of LPB at the given time frame

次要结局

  • Movement control impairment(Baseline, 6, 12 and 24 months follow-up)
  • Objective assessment of physical activity with accelerometer(Baseline, 6, 12 and 24 months follow-up)
  • Fear-avoidance beliefs questionnaire(Baseline, 6, 12 and 24 months follow-up)

研究者

发起方
UKK Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaana Suni

Senior Reseracher

UKK Institute

研究点 (1)

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