NCT01787565

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

April 6, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

January 22, 2013

Last Update Submit

April 4, 2016

Conditions

Back Pain

Keywords

non-interventionalclinicalinvestigationlowbackpainpainPREMIER

Outcome Measures

Primary Outcomes (1)

  • Roland Morris Disability Questionnaire

    Change from baseline

    3 months

Secondary Outcomes (45)

  • Roland Morris Disability Questionnaire

    6 months

  • Self-reported low back pain intensity

    3 months

  • Self-reported low back pain intensity and Roland Morris Disability Questionnaire

    3 months

  • Global Assessment of Disease Activity

    any time up to 6 months

  • SF-12 (Short Form 12 Health Survey), v2.0 (Mental Component Summary Scale and Physical Component Summary Scale)

    3 months

  • +40 more secondary outcomes

Study Arms (2)

painPREMIER cohort

Other: painPREMIER cohort

Control cohort

Other: Control cohort

Interventions

painPREMIER cohortOTHER

Low back pain patients prospectively recruited during the study period and managed with painPREMIER.

painPREMIER cohort
Control cohortOTHER

A matched group of low back pain patients not managed with painPREMIER.

Control cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • New episode of low back pain
  • Member of Terveystalo health insurance scheme

You may not qualify if:

  • Previous back pain related healthcare visit in the last 3 months
  • Patients identified as having a 'red flag' condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Helsinki, 00100, Finland

Location

Related Links

MeSH Terms

Conditions

Back PainPain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

February 8, 2013

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

April 6, 2016

Record last verified: 2016-04

Locations

FI(1)