NCT00672711

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 2, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

September 4, 2020

Status Verified

September 1, 2020

Enrollment Period

4.3 years

First QC Date

May 2, 2008

Last Update Submit

September 3, 2020

Conditions

Chronic Pain

Keywords

Complex Regional Pain SyndromeChronic Post-surgical PainGenetic susceptibilityCOMT

Outcome Measures

Primary Outcomes (1)

  • Neuropathic Pain Scale

    6 months

Secondary Outcomes (2)

  • EQ-5D

    6 months

  • Numeric Rating Scale for pain

    6 months

Study Arms (3)

C

APS

B

HPS

A

LPS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing shoulder surgery

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

William Beaumont Hospitals

Royal Oak, Michigan, 48073, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood serum

MeSH Terms

Conditions

Chronic PainComplex Regional Pain SyndromesPain, PostoperativeGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAutonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesPostoperative ComplicationsPathologic ProcessesDisease SusceptibilityDisease Attributes

Study Officials

  • Craig Hartrick, MD

    Corewell Health East

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2008

First Posted

May 6, 2008

Study Start

April 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

September 4, 2020

Record last verified: 2020-09

Locations

US(2)