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Completed

NCT Number: NCT00669006

Neuropathic Pain Database

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

London Health Sciences Centre- St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. To establish the infrastructure for a national Neuropathic Pain Database.

    Time frame: 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 outcomes

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Collaborators

  • Canada Foundation for Innovation
  • Pfizer

Registry information

Official study title

National Neuropathic Pain Database Study

Acronym: NePDatabase

Important dates

Study start
2008
Primary completion
2012
Study completion
2020
First posted
Apr 29, 2008
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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