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
- Conditions
- Back Pain
- Interventions
- Other: Control cohortOther: painPREMIER cohort
- Registration Number
- NCT01787565
- Lead Sponsor
- Pfizer
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 86
- New episode of low back pain
- Member of Terveystalo health insurance scheme
- Previous back pain related healthcare visit in the last 3 months
- Patients identified as having a 'red flag' condition
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control cohort Control cohort - painPREMIER cohort painPREMIER cohort -
- Primary Outcome Measures
Name Time Method Roland Morris Disability Questionnaire 3 months Change from baseline
- Secondary Outcome Measures
Name Time Method Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale 6 months Change from baseline
Self-reported low back pain intensity 3 months Change from baseline
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 Changes from baseline
All-cause absence days and costs associated with sick leave 6 months Comparison between painPREMIER cohort and control cohort
painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire) 3 months To evaluate the change from baseline and correlation between the instruments in the painPREMIER cohort
Sub-group analysis 6 months To evaluate patterns of use and outcomes in subgroups
Daily sleep intereference rating scale 6 months Change from baseline
Roland Morris Disability Questionnaire 6 months Change from baseline
PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4) 6 months Proportion of patients at risk for depression and/or anxiety
Total low back pain direct medical costs 6 months Comparison of pre and post-enrollment for both cohorts
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 Comparison between painPREMIER and control cohort
Specialist Occupational Health Provider Satisfaction After enrolment complete estimated 4 months Specialist Occupational Health Provider Satisfaction with painPREMIER
Semi-structured interview 6 months Patient feedback
Specialist Occupational Health Provider Engagement 6 months Specialist Occupational Health Provider Engagement with portal
Specialist Occupational Health Provider treatment recommendations 6 months Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations
Global Assessment of Disease Activity any time up to 6 months Change from baseline
EQ5-D Health Questionnaire 6 months Change from baseline
All-cause pharmacy and medical resource use/costs 6 months Comparison of pre and post-enrollment for both cohorts
Self-reported low back pain intensity and Roland Morris Disability Questionnaire 6 months Proportion of patients with at least 30% and 50% improvement
SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale) 6 months Change from baseline
Low back pain-related medical resource use/costs and pharmacy use/costs 6 months Comparison of pre and post-enrollment for both cohorts
Overall all costs via claims and absence data 6 months Comparison between painPREMIER and control cohort
Net Promoter Score 3 months Net Promoter Score
Patient engagement/treatment adherence 6 months Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy
Low back pain-specific medical resource use/costs 6 months Comparison of pre and post-enrollment for both cohorts
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 Changes from baseline (if collected at BL)
Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT) 3 months Changes from baseline
Patient Satisfaction 6 months Patient Satisfaction with painPREMIER
TAMPA17 Scale for Kinesiophobia, PHQ4, PHQ8, (Patient Health Questionnaire for Depression and Anxiety-4 and 8), GAD7 (Generalized Anxiety Disorder 7-item scale) Baseline To evaluate the correlation between TAMPA17, PHQ4, PHQ8, GAD7 baseline assessments in the painPREMIER cohort
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇫🇮Helsinki, Finland