NCT01900223

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
786

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2013

Shorter than P25 for all trials

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

June 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 14, 2014

Status Verified

January 1, 2014

Enrollment Period

4 months

First QC Date

July 8, 2013

Last Update Submit

January 13, 2014

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • preoperative pain intensity

    recalled

Study Arms (1)

Shoulder prosthesis bearer

Eligibility Criteria

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

Patients in the Danish Shoulder Arthroplasty Register

You may qualify if:

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

You may not qualify if:

  • Secondary prosthesis
  • Bilateral prosthesis
  • Age below 18
  • Reoperated in the same shoulder after the prosthesis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karen T Bjørnholdt, M.D.

    Aarhus University, Horsens Hospital

    PRINCIPAL INVESTIGATOR

  • 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 CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D., Ph.D.-student

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 16, 2013

Study Start

June 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

January 14, 2014

Record last verified: 2014-01