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.
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.
Study Type
OBSERVATIONAL
Enrollment
86
Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
A matched group of low back pain patients not managed with painPREMIER.
Pfizer Investigational Site
Helsinki, Finland
Roland Morris Disability Questionnaire
Change from baseline
Time frame: 3 months
Roland Morris Disability Questionnaire
Change from baseline
Time frame: 6 months
Self-reported low back pain intensity
Change from baseline
Time frame: 3 months
Self-reported low back pain intensity and Roland Morris Disability Questionnaire
Proportion of patients with at least 30% and 50% improvement
Time frame: 3 months
Global Assessment of Disease Activity
Change from baseline
Time frame: any time up to 6 months
SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
Change from baseline
Time frame: 3 months
EQ5-D Health Questionnaire
Change from baseline
Time frame: 3 months
PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
Proportion of patients at risk for depression and/or anxiety
Time frame: 3 months
Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)
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Changes from baseline (if collected at BL)
Time frame: 3 months
Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)
Changes from baseline
Time frame: 3 months
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)
Changes from baseline
Time frame: 3 months
All-cause absence days and costs associated with sick leave
Comparison between painPREMIER cohort and control cohort
Time frame: 3 months
All-cause pharmacy and medical resource use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 3 months
Low back pain-related medical resource use/costs and pharmacy use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 3 months
Low back pain-specific medical resource use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 3 months
Total low back pain direct medical costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 3 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
Comparison between painPREMIER and control cohort
Time frame: 3 months
Overall all costs via claims and absence data
Comparison between painPREMIER and control cohort
Time frame: 3 months
Patient Satisfaction
Patient Satisfaction with painPREMIER
Time frame: 3 months
Specialist Occupational Health Provider Satisfaction
Specialist Occupational Health Provider Satisfaction with painPREMIER
Time frame: After enrolment complete estimated 4 months
Net Promoter Score
Net Promoter Score
Time frame: 1 week
Semi-structured interview
Patient feedback
Time frame: 6 months
Specialist Occupational Health Provider Engagement
Specialist Occupational Health Provider Engagement with portal
Time frame: 6 months
Specialist Occupational Health Provider treatment recommendations
Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations
Time frame: 6 months
Patient engagement/treatment adherence
Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy
Time frame: 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)
To evaluate the correlation between TAMPA17, PHQ4, PHQ8, GAD7 baseline assessments in the painPREMIER cohort
Time frame: Baseline
painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire)
To evaluate the change from baseline and correlation between the instruments in the painPREMIER cohort
Time frame: 3 months
Sub-group analysis
To evaluate patterns of use and outcomes in subgroups
Time frame: 6 months
Daily sleep intereference rating scale
Change from baseline
Time frame: 3 months
Daily sleep intereference rating scale
Change from baseline
Time frame: 6 months
Self-reported low back pain intensity and Roland Morris Disability Questionnaire
Proportion of patients with at least 30% and 50% improvement
Time frame: 6 months
SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
Change from baseline
Time frame: 6 months
EQ5-D Health Questionnaire
Change from baseline
Time frame: 6 months
PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
Proportion of patients at risk for depression and/or anxiety
Time frame: 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)
Changes from baseline (if collected at BL)
Time frame: 6 months
Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale
Change from baseline
Time frame: 6 months
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)
Changes from baseline
Time frame: 6 months
All-cause absence days and costs associated with sick leave
Comparison between painPREMIER cohort and control cohort
Time frame: 6 months
All-cause pharmacy and medical resource use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 6 months
Low back pain-related medical resource use/costs and pharmacy use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 6 months
Low back pain-specific medical resource use/costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 6 months
Total low back pain direct medical costs
Comparison of pre and post-enrollment for both cohorts
Time frame: 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
Comparison between painPREMIER and control cohort
Time frame: 6 months
Overall all costs via claims and absence data
Comparison between painPREMIER and control cohort
Time frame: 6 months
Patient Satisfaction
Patient Satisfaction with painPREMIER
Time frame: 6 months
Net Promoter Score
Net Promoter Score
Time frame: 3 months