Clinical trial NCT01787565: 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
Official title: 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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Back Pain
Keywords: non-interventional
clinical
investigation
low
back
pain
painPREMIER
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Terveystalo
First posted: 2013-02-08
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Members of the Terveystalo health insurance scheme presenting with a new episode of low back pain

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.

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

Primary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Roland Morris Disability Questionnaire
timeFrame: 6 months
measure: Self-reported low back pain intensity
timeFrame: 3 months
measure: Self-reported low back pain intensity and Roland Morris Disability Questionnaire
timeFrame: 3 months
measure: Global Assessment of Disease Activity
timeFrame: any time up to 6 months
measure: SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
timeFrame: 3 months
measure: EQ5-D Health Questionnaire
timeFrame: 3 months
measure: PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
timeFrame: 3 months
measure: Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)
timeFrame: 3 months
measure: Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: All-cause absence days and costs associated with sick leave
timeFrame: 3 months
measure: All-cause pharmacy and medical resource use/costs
timeFrame: 3 months
measure: Low back pain-related medical resource use/costs and pharmacy use/costs
timeFrame: 3 months
measure: Low back pain-specific medical resource use/costs
timeFrame: 3 months
measure: Total low back pain direct medical costs
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: Overall all costs via claims and absence data
timeFrame: 3 months
measure: Patient Satisfaction
timeFrame: 3 months
measure: Specialist Occupational Health Provider Satisfaction
timeFrame: After enrolment complete estimated 4 months
measure: Net Promoter Score
timeFrame: 1 week
measure: Semi-structured interview
timeFrame: 6 months
measure: Specialist Occupational Health Provider Engagement
timeFrame: 6 months
measure: Specialist Occupational Health Provider treatment recommendations
timeFrame: 6 months
measure: Patient engagement/treatment adherence
timeFrame: 6 months
measure: TAMPA17 Scale for Kinesiophobia, PHQ4, PHQ8, (Patient Health Questionnaire for Depression and Anxiety-4 and 8), GAD7 (Generalized Anxiety Disorder 7-item scale)
timeFrame: Baseline
measure: painDETECT, TAMPA17 Scale for Kinesiophobia, LBPI (low back pain intensity) and RMDQ (Roland Morris Disability Questionnaire)
timeFrame: 3 months
measure: Sub-group analysis
timeFrame: 6 months
measure: Daily sleep intereference rating scale
timeFrame: 3 months
measure: Daily sleep intereference rating scale
timeFrame: 6 months
measure: Self-reported low back pain intensity and Roland Morris Disability Questionnaire
timeFrame: 6 months
measure: SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)
timeFrame: 6 months
measure: EQ5-D Health Questionnaire
timeFrame: 6 months
measure: PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)
timeFrame: 6 months
measure: Self-reported depression PHQ-8 (Patient Health Questionnaire for Depression and Anxiety-8) and anxiety GAD-7 (Generalized Anxiety Disorder 7-item scale)
timeFrame: 6 months
measure: Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale
timeFrame: 6 months
measure: 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)
timeFrame: 6 months
measure: All-cause absence days and costs associated with sick leave
timeFrame: 6 months
measure: All-cause pharmacy and medical resource use/costs
timeFrame: 6 months
measure: Low back pain-related medical resource use/costs and pharmacy use/costs
timeFrame: 6 months
measure: Low back pain-specific medical resource use/costs
timeFrame: 6 months
measure: Total low back pain direct medical costs
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: Overall all costs via claims and absence data
timeFrame: 6 months
measure: Patient Satisfaction
timeFrame: 6 months
measure: Net Promoter Score
timeFrame: 3 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: