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NePDatabase: Neuropathic Pain Database

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT00669006
Collaborator
Canada Foundation for Innovation (Other), Pfizer (Industry)
789
Enrollment
1
Location
142.8
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To establish the infrastructure for a national neuropathic pain database.

To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability, and quality of life.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The database will provide standard information on demographics, diagnosis, treatment interventions and outcome modeled on guidelines from the expert panel on initiatives on Methods, Measurement and Pain Assessment in Clinical Trials (IMMPACT)(Turk et al.,Pain 2003;106:337-345) The IMMPACT panel determined that patients should be evaluated according to six core domains as follows: Pain, physical functioning, emotional functioning, subject rating of global satisfaction with treatment, symptoms and adverse events and subject disposition.

    The database will allow us to examine outcomes based on single (eg. pregabalin) and multiple (e.g tricyclic antidepressants and gabalin) therapeutic interventions. Standard guidelines for management of neuropathic pain acknowledge that polypharmacy is appropriate when individual first line treatments fail to provide adequate pain relief (Gilron I et al., CMAJ 2006; 175: 265-275; Attal N et al., European Journal of Neurology 2006; 13: 1153-1169)

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    789 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    National Neuropathic Pain Database Study
    Study Start Date :
    Apr 1, 2008
    Actual Primary Completion Date :
    Feb 1, 2012
    Actual Study Completion Date :
    Feb 24, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    1

    New patients with a diagnosis of Neuropathic Pain

    Outcome Measures

    Primary Outcome Measures

    1. To establish the infrastructure for a national Neuropathic Pain Database. [2 years]

      To establish the infrastructure for a National Neuropathic Pain Database, with a composite primary outcome measure in average pain intensity (based on average pain intensity of BPI) and reduction in disability (based on Interference Scale Score of BPI))

    Secondary Outcome Measures

    1. To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life. [2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Primarily Neuropathic Pain

    • Able to give informed consent

    • Estimated Life Expectancy of 2 years

    Exclusion Criteria:

    • Not primarily neuropathic pain

    • Declined participation- too much traveling

    • Declined participation- Unknown

    • Declined participation- Other, specify

    • Considered unreliable- personality disorder

    • Considered unreliable- cognitive impairment

    • Considered unreliable- substance abuse

    • Considered unreliable- Other

    • Language barrier

    • Exceeded quarterly quota

    • Presentation with progressive or recurrent cancer, fibromyalgia, perineal pain of unknown etiology

    • Other, specify

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Sciences Centre- St. Joseph's Health Care London Ontario Canada N6A 4V2

    Sponsors and Collaborators

    • Lawson Health Research Institute
    • Canada Foundation for Innovation
    • Pfizer

    Investigators

    • Principal Investigator: Dwight Moulin, MD, London Health Sciences Centre- St. Joseph's Health Care

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT00669006
    Other Study ID Numbers:
    • R-07-835
    • 13930E
    First Posted:
    Apr 29, 2008
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Lawson Health Research Institute
    neuropathic pain
    database
    prospective
    national
    Additional relevant MeSH terms:
    Neuralgia

    Study Results

    No Results Posted as of Oct 19, 2021