Susceptibility to Chronic Post-Traumatic Extremity Pain

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

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 Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospitals
    • Troy, Michigan, United States, 48085
      • William Beaumont Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing shoulder surgery

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
C; APS
B; HPS
A; LPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropathic Pain Scale	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
EQ-5D	6 months
Numeric Rating Scale for pain	6 months

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Collaborators: Oakland University; Beaumont Foundation of America

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 2, 2008
• First Submitted That Met QC Criteria: May 2, 2008
• First Posted (Estimate): May 6, 2008

Study Record Updates

• Last Update Posted (Actual): September 4, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Complex Regional Pain Syndrome; COMT; Genetic susceptibility; Chronic Post-surgical Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Chronic Pain; Disease Susceptibility
• Other Study ID Numbers: 2007-200