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Chronic Pain After Shoulder Arthroplasty

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ClinicalTrials.gov Identifier: NCT01900223
Recruitment Status : Completed
First Posted : July 16, 2013
Last Update Posted : January 14, 2014
Sponsor:
Collaborators:
Central Denmark Region
Augustinus Fonden
Horsens Hospital
Information provided by (Responsible Party):
Karen Bjørnholdt, University of Aarhus

Brief 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.

Condition or disease
Chronic Pain

Study Type : Observational
Actual Enrollment : 786 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Chronic Pain After Shoulder Arthroplasty: Epidemiology and Risk Factors.
Study Start Date : June 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Group/Cohort
Shoulder prosthesis bearer



Primary Outcome Measures :
  1. Current pain intensity [ Time Frame: At time of completing the questionnaire, which is sent to patients 1-2 years after their shoulderprosthesis. ]
    Pain score by Numeric Rating Scale 0-10


Secondary Outcome Measures :
  1. preoperative pain intensity [ Time Frame: recalled ]
    Pain intensity by Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01900223


Sponsors and Collaborators
Karen Bjørnholdt
Central Denmark Region
Augustinus Fonden
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

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
First Posted: July 16, 2013    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014

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