Chronic Pain
Conditions
Keywords
Complex Regional Pain Syndrome, Chronic Post-surgical Pain, Genetic susceptibility, COMT
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.
Interventions
None listed
Sponsors
Beaumont Foundation of America
Oakland University
Corewell Health East
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropathic Pain Scale | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| EQ-5D | 6 months |
| Numeric Rating Scale for pain | 6 months |
Countries
United States
Outcome results
None listed