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

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.

Study Overview

• Status: Terminated
• Conditions: Back Pain
• Intervention / Treatment: Other: painPREMIER cohort; Other: Control cohort

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00100
    • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Members of the Terveystalo health insurance scheme presenting with a new episode of low back pain

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
painPREMIER cohort	Other: painPREMIER cohort; Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
Control cohort	Other: Control cohort; A matched group of low back pain patients not managed with painPREMIER.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pfizer
• Collaborators: Terveystalo

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: January 22, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: pain; back; clinical; non-interventional; investigation; low; painPREMIER
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: X9001016