NCT00908102Unknown不适用
The Prevalence of Low Back Symptoms in a Finnish Forestry Company - Effectiveness of Primary Care Interventions for Non-acute Low Back Symptoms in Occupational Health. Two Separate Randomised Controlled Trials (RCT) of Various Levels.
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 505
- 试验地点
- 2
- 主要终点
- Low back pain (VAS)
研究概览
简要总结
The purpose of this study is:
- Epidemiological part: characteristics of low back pain patients from a forestry company in Finland. Data is collected from occupational health databases and self administered questionnaires.
- Intervention: To determine the effectiveness and cost-effectiveness of several different interventions in subacute low back pain (LBP) patients in occupational health (OH).
详细描述
Eligible subjects were divided into two randomised controlled trials with the name of "mild" or "moderate" low back pain trials (interventions) and also mild vs natural course (NC) and moderate vs. NC interventions.
Pain, disability and quality of life were collected up to 2 years by self-administered questionnaires and sickness absences were gathered from electronical records for at least 4 year's follow up time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 56 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-56 years
- •present employment at the company
- •at least one criteria out the following qualified for the study:
- •nonspecific LBP with the duration of 2 weeks or more
- •radiating, present low back pain
- •recurrent LBP (2 or more episodes per year)
- •work absence because of LBP
- •included subjects also responded having low back pain during preceding week prior to the questionnaire (VAS ≥ 10 mm, Visual Analogue Scale 0-100 mm)
- •According to pain level, patients were later divided into two separate RCT's, "mild": VAS 10mm - 34mm, "moderate": VAS 35mm or more.
排除标准
- •retirement
- •acute nerve root compression symptoms
- •malignant tumor
- •recent fracture
- •severe osteoporosis
- •other specific disease preventing participation in the follow-up
结局指标
主要结局
Low back pain (VAS)
时间窗: 0, 3, 6, 12, 24 months
Disability (Roland Morris 18)
时间窗: 0, 3, 6, 12, 24 months
Sickness absence days (Low back (LB) specific, other than LB, total)
时间窗: 6, 12, 24, 36, 48 months
Quality of Life (15-D)
时间窗: 0, 3, 6, 12, 24 months
次要结局
- Disability (Oswestry's index)(3, 6, 12, 24 months)
- Sickness absence periods(6, 12, 24, 36, 48 months)
研究者
Jarmo Rantonen
MD
University of Helsinki
研究点 (2)
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