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

Pfizer1 site in 1 country86 target enrollmentJanuary 2013

ConditionsBack Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Back Pain
Sponsor: Pfizer
Enrollment: 86
Locations: 1
Primary Endpoint: Roland Morris Disability Questionnaire
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

January 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Roland Morris Disability Questionnaire

Time Frame: 3 months

Change from baseline

Secondary Outcomes

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)