Clinical trial NCT00669006: Neuropathic Pain Database
Official title: National Neuropathic Pain Database Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuropathic Pain
Keywords: neuropathic pain
database
prospective
national
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canada Foundation for Innovation
name: Pfizer
First posted: 2008-04-29
Enrollment: 789
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: New patients referred to the outpatient pain clinic with a diagnosis of Neuropathic Pain.

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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: To establish the infrastructure for a national Neuropathic Pain Database.
timeFrame: 2 years
Secondary outcomes:
measure: To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.
timeFrame: 2 years
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre- St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: London Health Sciences Centre- St. Joseph's Health Care
name: Dwight Moulin, MD
role: PRINCIPAL_INVESTIGATOR
References: