Chronic Pain After Shoulder Arthroplasty

Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain

• Study Type: Observational
• Enrollment (Actual): 786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in the Danish Shoulder Arthroplasty Register

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Shoulder prosthesis bearer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
preoperative pain intensity	Pain intensity by Likert scale	recalled

Collaborators and Investigators

• Sponsor: Karen Bjørnholdt
• Collaborators: Central Denmark Region; Horsens Hospital; Augustinus Fonden
• Investigators: Principal Investigator: Karen T Bjørnholdt, M.D., Aarhus University, Horsens Hospital; Study Chair: Birgitte Brandsborg, M.D., Ph.D., Aarhus University Hospital; Study Chair: Lone Nikolajsen, M.D., DMSc, Aarhus University Hospital; Study Chair: Kjeld Søballe, M.D., DMSc, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 8, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 16, 2013

Study Record Updates

• Last Update Posted (Estimate): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 13, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: KTB-003