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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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
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Back Pain

Intervention / Treatment
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* Other: painPREMIER cohort
* Other: Control cohort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: New episode of low back pain Member of Terveystalo health insurance scheme Exclusion Criteria: Previous back pain related healthcare visit in the last 3 months Patients identified as having a 'red flag' condition

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| painPREMIER cohort<br> | Other: painPREMIER cohort<br>* Low back pain patients prospectively recruited during the study period and managed with painPREMIER.<br>|
| Control cohort<br> | Other: Control cohort<br>* A matched group of low back pain patients not managed with painPREMIER.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire | Change from baseline | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire | Change from baseline | 6 months | 
| Self-reported low back pain intensity | Change from baseline | 3 months | 
| Self-reported low back pain intensity and Roland Morris Disability Questionnaire | Proportion of patients with at least 30% and 50% improvement | 3 months | 
| Global Assessment of Disease Activity | Change from baseline | 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 | 3 months | 
| EQ5-D Health Questionnaire | Change from baseline | 3 months | 
| PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4) | Proportion of patients at risk for depression and/or anxiety | 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) | Changes from baseline (if collected at BL) | 3 months | 
| Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT) | Changes from baseline | 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 | 3 months | 
| All-cause absence days and costs associated with sick leave | Comparison between painPREMIER cohort and control cohort | 3 months | 
| All-cause pharmacy and medical resource use/costs | Comparison of pre and post-enrollment for both cohorts | 3 months | 
| Low back pain-related medical resource use/costs and pharmacy use/costs | Comparison of pre and post-enrollment for both cohorts | 3 months | 
| Low back pain-specific medical resource use/costs | Comparison of pre and post-enrollment for both cohorts | 3 months | 
| Total low back pain direct medical costs | Comparison of pre and post-enrollment for both cohorts | 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 | 3 months | 
| Overall all costs via claims and absence data | Comparison between painPREMIER and control cohort | 3 months | 
| Patient Satisfaction | Patient Satisfaction with painPREMIER | 3 months | 
| Specialist Occupational Health Provider Satisfaction | Specialist Occupational Health Provider Satisfaction with painPREMIER | After enrolment complete estimated 4 months | 
| Net Promoter Score | Net Promoter Score | 1 week | 
| Semi-structured interview | Patient feedback | 6 months | 
| Specialist Occupational Health Provider Engagement | Specialist Occupational Health Provider Engagement with portal | 6 months | 
| Specialist Occupational Health Provider treatment recommendations | Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations | 6 months | 
| Patient engagement/treatment adherence | Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy | 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 | 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 | 3 months | 
| Sub-group analysis | To evaluate patterns of use and outcomes in subgroups | 6 months | 
| Daily sleep intereference rating scale | Change from baseline | 3 months | 
| Daily sleep intereference rating scale | Change from baseline | 6 months | 
| Self-reported low back pain intensity and Roland Morris Disability Questionnaire | Proportion of patients with at least 30% and 50% improvement | 6 months | 
| SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale) | Change from baseline | 6 months | 
| EQ5-D Health Questionnaire | Change from baseline | 6 months | 
| PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4) | Proportion of patients at risk for depression and/or anxiety | 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) | 6 months | 
| Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale | Change from baseline | 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 | 6 months | 
| All-cause absence days and costs associated with sick leave | Comparison between painPREMIER cohort and control cohort | 6 months | 
| All-cause pharmacy and medical resource use/costs | Comparison of pre and post-enrollment for both cohorts | 6 months | 
| Low back pain-related medical resource use/costs and pharmacy use/costs | Comparison of pre and post-enrollment for both cohorts | 6 months | 
| Low back pain-specific medical resource use/costs | Comparison of pre and post-enrollment for both cohorts | 6 months | 
| Total low back pain direct medical costs | Comparison of pre and post-enrollment for both cohorts | 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 | 6 months | 
| Overall all costs via claims and absence data | Comparison between painPREMIER and control cohort | 6 months | 
| Patient Satisfaction | Patient Satisfaction with painPREMIER | 6 months | 
| Net Promoter Score | Net Promoter Score | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low, non-interventional, clinical, investigation, back, pain, painPREMIER