Overview

This trial is active, not recruiting.

Condition chronic postoperative pain
Sponsor University of Aarhus
Collaborator Horsens Regional Hospital
Start date May 2014
End date October 2016
Trial size 150 participants
Trial identifier NCT02924519, 1-10-72-103-14

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Chronic postoperative pain
time frame: 6 months after surgery
Acute postoperative pain
time frame: 24 hours after surgery

Secondary Outcomes

Measure
Acute postoperative pain
time frame: 1 week after surgery
Acute postoperative pain
time frame: 3 month after surgery
Preoperative psychological predictors for chronic pain
time frame: 6 months after surgery
Preoperative psychological predictors for chronic pain
time frame: 6 months after surgery
Preoperative psychological predictors for chronic pain
time frame: 6 months after surgery
Preoperative physical predictors for chronic pain
time frame: 6 months after surgery
Preoperative comorbidity
time frame: 6 months after surgery

Eligibility Criteria

Male or female participants from 18 years up to 110 years old.

Inclusion Criteria: - Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection). Exclusion Criteria: - • < 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

Additional Information

Official title Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery
Description This study is a prospective cohort with 6 months follow-up. Patients receive 5 questionnaires (preoperatively, 24 hours, 1 week, 3 months, 6 months, 1 and 2 years after surgery). The questionnaires contain questions about: - Preoperative shoulder pain (type, intensity and duration) - Preoperative pain in other areas besides the shoulder - Brief Pain Inventory (BPI) - Western Ontario Rotator Cuff Index (WORC) - Single Assessment Numeric Evaluation (SANE) - 3 validated physiological questionnaires: - State Trait Anxiety (STAI) - Pain Catastrophizing Scale (PCS) - Hospital Anxiety and Depression Scale (HADS) In addition a cold pressor test is performed on the day of surgery to test the patients' threshold and ability to repress pain.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by University of Aarhus.