NCT01787565终止不适用
Pilot Evaluation to Assess the Clinical and Economic Impact of Pfizer's Pain Management Program (painPREMIER) in the Treatment of Low Back Pain, in an Occupational Health Care Setting in Finland
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Roland Morris Disability Questionnaire
研究概览
简要总结
The aim of this investigation is to determine whether the use of painPREMIER will significantly improve function in patients with low back pain in an occupational health clinical setting. painPREMIER is a tool that assists clinicians in the accurate diagnosis of back pain and associated problems in order to treat them most effectively.
详细描述
Patients presenting at feeder sites to be referred to low back pain clinic and assessed for eligibility A decision was made to terminate this study on 09 OCT 2013. The study was terminated for operational/business reasons. This study was not terminated for reasons of safety or efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New episode of low back pain
- •Member of Terveystalo health insurance scheme
排除标准
- •Previous back pain related healthcare visit in the last 3 months
- •Patients identified as having a 'red flag' condition
结局指标
主要结局
Roland Morris Disability Questionnaire
时间窗: 3 months
Change from baseline
次要结局
- Self-reported absenteeism, presenteeism, lost productivity and activity, over prior 2 weeks, measured by Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire (painPREMIER cohort)(6 months)
- All-cause absence days and costs associated with sick leave(6 months)
- painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire)(3 months)
- Sub-group analysis(6 months)
- Daily sleep intereference rating scale(6 months)
- Roland Morris Disability Questionnaire(6 months)
- PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)(6 months)
- Total low back pain direct medical costs(6 months)
- Overall low back pain costs via claims data and imputed WPAI:LBP Work Productivity and Activity Impairment (WPAI): Specific Helath Problem (Low Back Pain) questionnaire(6 months)
- Specialist Occupational Health Provider Satisfaction(After enrolment complete estimated 4 months)
- Semi-structured interview(6 months)
- Specialist Occupational Health Provider Engagement(6 months)
- Specialist Occupational Health Provider treatment recommendations(6 months)
- Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale(6 months)
- Global Assessment of Disease Activity(any time up to 6 months)
- EQ5-D Health Questionnaire(6 months)
- Self-reported low back pain intensity(3 months)
- Self-reported low back pain intensity and Roland Morris Disability Questionnaire(6 months)
- SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)(6 months)
- Low back pain-related medical resource use/costs and pharmacy use/costs(6 months)
- Overall all costs via claims and absence data(6 months)
- Net Promoter Score(3 months)
- Patient engagement/treatment adherence(6 months)
- Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)(6 months)
- Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)(3 months)
- All-cause pharmacy and medical resource use/costs(6 months)
- Low back pain-specific medical resource use/costs(6 months)
- Patient Satisfaction(6 months)
- TAMPA17 Scale for Kinesiophobia, PHQ4, PHQ8, (Patient Health Questionnaire for Depression and Anxiety-4 and 8), GAD7 (Generalized Anxiety Disorder 7-item scale)(Baseline)
研究者
研究点 (1)
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