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

Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01787565
• Other study ID #: X9001016
• Status: Terminated
• Phase: N/A
• First received: January 22, 2013
• Last updated: April 4, 2016
• Start date: January 2013
• Est. completion date: January 2014

Study information

• Verified date: April 2016
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 86
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• painPREMIER cohort
Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
• Control cohort
A matched group of low back pain patients not managed with painPREMIER.

Locations

Country	Name	City	State
Finland	Pfizer Investigational Site	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Terveystalo

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Roland Morris Disability Questionnaire	Change from baseline	3 months	No
Secondary	Roland Morris Disability Questionnaire	Change from baseline	6 months	No
Secondary	Self-reported low back pain intensity	Change from baseline	3 months	No
Secondary	Self-reported low back pain intensity and Roland Morris Disability Questionnaire	Proportion of patients with at least 30% and 50% improvement	3 months	No
Secondary	Global Assessment of Disease Activity	Change from baseline	any time up to 6 months	No
Secondary	SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)	Change from baseline	3 months	No
Secondary	EQ5-D Health Questionnaire	Change from baseline	3 months	No
Secondary	PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)	Proportion of patients at risk for depression and/or anxiety	3 months	No
Secondary	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	No
Secondary	Self-reported catastrophizing - Coping Strategies Questionnaire - Catastrophizing scale (CSQ-CAT)	Changes from baseline	3 months	No
Secondary	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	No
Secondary	All-cause absence days and costs associated with sick leave	Comparison between painPREMIER cohort and control cohort	3 months	No
Secondary	All-cause pharmacy and medical resource use/costs	Comparison of pre and post-enrollment for both cohorts	3 months	No
Secondary	Low back pain-related medical resource use/costs and pharmacy use/costs	Comparison of pre and post-enrollment for both cohorts	3 months	No
Secondary	Low back pain-specific medical resource use/costs	Comparison of pre and post-enrollment for both cohorts	3 months	No
Secondary	Total low back pain direct medical costs	Comparison of pre and post-enrollment for both cohorts	3 months	No
Secondary	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	No
Secondary	Overall all costs via claims and absence data	Comparison between painPREMIER and control cohort	3 months	No
Secondary	Patient Satisfaction	Patient Satisfaction with painPREMIER	3 months	No
Secondary	Specialist Occupational Health Provider Satisfaction	Specialist Occupational Health Provider Satisfaction with painPREMIER	After enrolment complete estimated 4 months	No
Secondary	Net Promoter Score	Net Promoter Score	1 week	No
Secondary	Semi-structured interview	Patient feedback	6 months	No
Secondary	Specialist Occupational Health Provider Engagement	Specialist Occupational Health Provider Engagement with portal	6 months	No
Secondary	Specialist Occupational Health Provider treatment recommendations	Specialist Occupational Health Provider treatment recommendations vs painPREMIER treatment recommendations	6 months	No
Secondary	Patient engagement/treatment adherence	Platform use, CBST(Cognitive Behavioral Skills Training) module use and adherence to pharmacological therapy	6 months	No
Secondary	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	No
Secondary	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	No
Secondary	Sub-group analysis	To evaluate patterns of use and outcomes in subgroups	6 months	No
Secondary	Daily sleep intereference rating scale	Change from baseline	3 months	No
Secondary	Daily sleep intereference rating scale	Change from baseline	6 months	No
Secondary	Self-reported low back pain intensity and Roland Morris Disability Questionnaire	Proportion of patients with at least 30% and 50% improvement	6 months	No
Secondary	SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)	Change from baseline	6 months	No
Secondary	EQ5-D Health Questionnaire	Change from baseline	6 months	No
Secondary	PHQ-4 (Patient Health Questionnaire for Depression and Anxiety-4)	Proportion of patients at risk for depression and/or anxiety	6 months	No
Secondary	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	No
Secondary	Self-reported catastrophizing (CSQ-CAT) Coping Strategies Questionnaire - Catastrophizing scale	Change from baseline	6 months	No
Secondary	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	No
Secondary	All-cause absence days and costs associated with sick leave	Comparison between painPREMIER cohort and control cohort	6 months	No
Secondary	All-cause pharmacy and medical resource use/costs	Comparison of pre and post-enrollment for both cohorts	6 months	No
Secondary	Low back pain-related medical resource use/costs and pharmacy use/costs	Comparison of pre and post-enrollment for both cohorts	6 months	No
Secondary	Low back pain-specific medical resource use/costs	Comparison of pre and post-enrollment for both cohorts	6 months	No
Secondary	Total low back pain direct medical costs	Comparison of pre and post-enrollment for both cohorts	6 months	No
Secondary	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	No
Secondary	Overall all costs via claims and absence data	Comparison between painPREMIER and control cohort	6 months	No
Secondary	Patient Satisfaction	Patient Satisfaction with painPREMIER	6 months	No
Secondary	Net Promoter Score	Net Promoter Score	3 months	No

External Links

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