Clinical trial NCT00672711: Susceptibility to Chronic Post-Traumatic Extremity Pain
Official title: Susceptibility to Chronic Post-Traumatic Extremity Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Keywords: Complex Regional Pain Syndrome
Chronic Post-surgical Pain
Genetic susceptibility
COMT
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
Collaborators: name: Beaumont Foundation of America
name: Oakland University
First posted: 2008-05-06
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing shoulder surgery

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.

Eligibility 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

Primary outcomes:
measure: Neuropathic Pain Scale
timeFrame: 6 months
Secondary outcomes:
measure: EQ-5D
timeFrame: 6 months
measure: Numeric Rating Scale for pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospitals
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: Craig Hartrick, MD
role: PRINCIPAL_INVESTIGATOR
References: