Neuropathic Pain Database

Completed

• Conditions: Neuropathic Pain

• Registration Number: NCT00669006
• Lead Sponsor: Lawson Health Research Institute

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)

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-28
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Primary Completion: 2012-02
• Study Completion: 2020-02-24
• Status Verified: 2021-02
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 789

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To determine the longterm outcome of the management of chronic neuropathic pain including pain relief, disability and quality of life.	2 years

Trial Locations

Locations (1)

London Health Sciences Centre- St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada