Chronic Pain After Shoulder Arthroplasty

This study has been completed.
Sponsor:
Collaborators:
Central Denmark Region
Augustinusfonden,
Horsens Hospital
Information provided by (Responsible Party):
Karen Bjørnholdt, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01900223
First received: July 8, 2013
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition
Chronic Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Current pain intensity [ Time Frame: At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis. ] [ Designated as safety issue: No ]
    Pain score by Numeric Rating Scale 0-10


Secondary Outcome Measures:
  • preoperative pain intensity [ Time Frame: recalled ] [ Designated as safety issue: No ]
    Pain intensity by Likert scale


Enrollment: 786
Study Start Date: June 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Shoulder prosthesis bearer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients in the Danish Shoulder Arthroplasty Register

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01900223

Sponsors and Collaborators
Karen Bjørnholdt
Central Denmark Region
Augustinusfonden,
Horsens Hospital
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
  More Information

No publications provided

Responsible Party: Karen Bjørnholdt, M.D., Ph.D.-student, University of Aarhus
ClinicalTrials.gov Identifier: NCT01900223     History of Changes
Other Study ID Numbers: KTB-003
Study First Received: July 8, 2013
Last Updated: January 13, 2014
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014