Susceptibility to Chronic Post-Traumatic Extremity Pain

Completed

• Conditions: Chronic Pain

• Registration Number: NCT00672711
• Lead Sponsor: William Beaumont Hospitals

Brief Summary

The association between the COMT haplotypes and the presence or absence of CPSP or CRPS will be assessed stratifying the patients based on the individual categories of trauma or elective surgery.

Detailed Description

This will be a prospective association study in which we will recruit patients who have experienced single extremity trauma, or who have scheduled elective surgery on a single extremity. HRQoL will be determined at recruitment. We will identify their haplotypes and genotypes for 4 linked SNPs in the coding region of COMT as described by Diatchenko \[2\]. Patients will receive follow-up at 3 and 6 months following trauma or surgery. Individuals who report either neuropathic pain or a reduced HRQoL score will be more closely examined, in order to identify CPSP or CRPS. Statistical analyses will be performed to determine whether haplotypes are associated with the development of either condition, and to determine the strength of this association.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-05-02
• Study First Submitted QC: 2008-05-02
• Study First Posted: 2008-05-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Provide written Informed Consent prior to participation in the study
• Be at lease 18, but not more than 80 years of age
• Have the ability to read and understand the study procedures and the use of the pain scales and have the ability to communicate meaningfully with the Study Investigator and staff.
• Be free of other physical, mental, or medical conditions, which, in the opinion of the Investigator, makes Study participation inadvisable
• Is scheduled to undergo open or arthroscopic shoulder surgery
• If the subject is a female of childbearing potential, have a negative pregnancy test on the day of surgery.

Exclusion Criteria

• Has significant medical disease(s), laboratory abnormalities or conditions(s) that in the Investigator's judgment could compromise the Subject's welfare, ability to communicate with the Study staff, complete Study activities, or would otherwise contraindicate Study participation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain Scale	6 months

Secondary Outcome Measures

Name	Time	Method
EQ-5D	6 months
Numeric Rating Scale for pain	6 months

Trial Locations

Locations (2)

William Beaumont Hospital; 🇺🇸 Troy, Michigan, United States

William Beaumont Hospitals; 🇺🇸 Royal Oak, Michigan, United States