NCT02924519

Brief Summary

Shoulder disorders are frequent, often associated with pain and occur in 7-34% of the general population and in 21% of the elderly population. Of particular interest is prediction of postoperative pain after outpatient arthroscopic shoulder surgery since the clinical experience is that surgery does not always provides pain relief and the interindividual variation in acute postoperative pain intensity is significant. In addition, a Swedish study has shown that shoulder operations are associated with longer convalescence than other orthopaedic outpatient surgeries.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2014

Longer than P75 for all trials

Status
unknown

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

May 1, 2014

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 5, 2016

Status Verified

August 1, 2016

Enrollment Period

2.4 years

First QC Date

August 9, 2016

Last Update Submit

October 3, 2016

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (2)

  • Chronic postoperative pain

    Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. Chronic postoperative pain is defined as NRS\>=3 with an impact on daily living

    6 months after surgery

  • Acute postoperative pain

    Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS\>3= acute postoperative pain

    24 hours after surgery

Secondary Outcomes (7)

  • Acute postoperative pain

    1 week after surgery

  • Acute postoperative pain

    3 month after surgery

  • Preoperative psychological predictors for chronic pain

    6 months after surgery

  • Preoperative psychological predictors for chronic pain

    6 months after surgery

  • Preoperative psychological predictors for chronic pain

    6 months after surgery

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 110 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for ambulatory (outpatient) arthroscopic shoulder surgery

You may qualify if:

  • Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).

You may not qualify if:

  • \< 18 years
  • mental disorders
  • Unable to speak and/or read Danish
  • Shoulder surgery within the last year
  • Raynauds phenomenon
  • Cuff suture
  • Biceps tenodesis
  • Labrum suture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2016

First Posted

October 5, 2016

Study Start

May 1, 2014

Primary Completion

October 1, 2016

Study Completion

October 1, 2018

Last Updated

October 5, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share