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OpenTrials
Completed

NCT Number: NCT00672711

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Neuropathic Pain Scale

    Time frame: 6 months

Secondary outcomes

  1. EQ-5D

    Time frame: 6 months

  2. Numeric Rating Scale for pain

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Collaborators

  • Beaumont Foundation of America
  • Oakland University

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
May 6, 2008
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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