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Susceptibility to Chronic Post-Traumatic Extremity Pain

This study has been completed.
Sponsor:
Collaborators:
Beaumont Foundation of America
Oakland University
Information provided by (Responsible Party):
Craig Hartrick, MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00672711
First received: May 2, 2008
Last updated: September 18, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Susceptibility to Chronic Post-Traumatic Extremity Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • Neuropathic Pain Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EQ-5D [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Numeric Rating Scale for pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood serum


Enrollment: 250
Study Start Date: April 2008
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
C
APS
B
HPS
A
LPS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing shoulder surgery

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00672711

Locations
United States, Michigan
William Beaumont Hospitals
Royal Oak, Michigan, United States, 48073
William Beaumont Hospital
Troy, Michigan, United States, 48085
Sponsors and Collaborators
William Beaumont Hospitals
Beaumont Foundation of America
Oakland University
Investigators
Principal Investigator: Craig Hartrick, MD William Beaumont Hospitals
  More Information

No publications provided

Responsible Party: Craig Hartrick, MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00672711     History of Changes
Other Study ID Numbers: HIC 2007-200
Study First Received: May 2, 2008
Last Updated: September 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by William Beaumont Hospitals:
Complex Regional Pain Syndrome
Chronic Post-surgical Pain
Genetic susceptibility
COMT

Additional relevant MeSH terms:
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013