Susceptibility to Chronic Post-Traumatic Extremity Pain
This study has been completed.
Beaumont Foundation of America
Information provided by (Responsible Party):
Craig Hartrick, MD, William Beaumont Hospitals
First received: May 2, 2008
Last updated: September 18, 2012
Last verified: September 2012
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.
||Observational Model: Case Control
Time Perspective: Prospective
||Susceptibility to Chronic Post-Traumatic Extremity Pain
Primary Outcome Measures:
- Neuropathic Pain Scale [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2012 (Final data collection date for primary outcome measure)
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 . 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.
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients undergoing shoulder surgery
- 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.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00672711
|William Beaumont Hospitals
|Royal Oak, Michigan, United States, 48073 |
|William Beaumont Hospital
|Troy, Michigan, United States, 48085 |
William Beaumont Hospitals
Beaumont Foundation of America
||Craig Hartrick, MD
||William Beaumont Hospitals
No publications provided
||Craig Hartrick, MD, Principal Investigator, William Beaumont Hospitals
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 2, 2008
||September 18, 2012
||United States: Institutional Review Board
Keywords provided by William Beaumont Hospitals:
Complex Regional Pain Syndrome
Chronic Post-surgical Pain
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014