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NCT01900223 Clinical Trial

Chronic Pain After Shoulder Arthroplasty

Chronic Pain Clinical Trial

Official title:
Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01900223
Other study ID # KTB-003
Secondary ID
Status Completed
Phase N/A
First received July 8, 2013
Last updated January 13, 2014
Start date June 2013
Est. completion date October 2013

Study information
Verified date January 2014
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Chronic pain is relatively common after different types of surgery. The investigators intend to study prevalence, characteristics and risk factors of chronic pain after shoulder arthroplasty, focusing on neuropathic pain characteristics, and risk factors such as preoperative pain, severe acute postoperative pain, age, gender, and pain elsewhere.

Recruitment information / eligibility
Status Completed
Enrollment 786
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients operated with any shoulder prosthesis between april 2011 and april 2012 in Denmark

Exclusion Criteria:

- Secondary prosthesis

- Bilateral prosthesis

- Age below 18

- Reoperated in the same shoulder after the prosthesis

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (4)
Lead Sponsor Collaborator
Karen Bjørnholdt Augustinus Fonden, Central Denmark Region, Horsens Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Current pain intensity Pain score by Numeric Rating Scale 0-10 At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis. No
Secondary preoperative pain intensity Pain intensity by Likert scale recalled No
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