Neuropathic Pain Database

Neuropathic Pain Clinical Trial

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Official title:

National Neuropathic Pain Database Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00669006
• Other study ID #: R-07-835
• Secondary ID: 13930E
• Status: Completed
• Start date: April 2008
• Est. completion date: February 24, 2020

Study information

• Verified date: February 2021
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 789
• Est. completion date: February 24, 2020
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Locations

Country	Name	City	State
Canada	London Health Sciences Centre- St. Joseph's Health Care	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canada Foundation for Innovation, Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the infrastructure for a national Neuropathic Pain Database.	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))	2 years
Secondary	To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.		2 years