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From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy (FACTS2)

This study has been completed.
Vejle Hospital
Information provided by (Responsible Party):
Morten Rune Eckhardt, Odense University Hospital Identifier:
First received: March 2, 2012
Last updated: June 16, 2014
Last verified: June 2014

Shoulder pain is a well known problem after thoracical surgery. The pathogenesis of the pain is uncertain, but mainly a mix of referred pain and mechanical strain to the shoulder. It is believed to last a few days. Persisting shoulder pain after thoracical surgery is a problem 1 year after surgery, but it is unknown if it is related to acute postoperative shoulder pain.

The purpose of the study is to systematically describe postoperative shoulder pain after lobectomy and examine the time progress up to 1 year after surgery.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Shoulder Pain [ Time Frame: 12 months ]
  • Shoulder range of motion [ Time Frame: 12 months ]
    Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction

Secondary Outcome Measures:
  • Thoracical Pain [ Time Frame: 12 months ]
  • Presence of allodynia and hyperalgesia on the shoulder on the operated side. [ Time Frame: 1. postoperative day ]
    Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder.

  • Quantitative sensory testing values on the shoulder [ Time Frame: 12 months ]

    Quantitative sensory testing values in referred pain area compared to contralateral side and preoperative values.

    The following quantitative sensory tests are performed:

    Cold Detection Threshold,Warm Detection Threshold, Cold Pain Threshold, Heat Pain Threshold, Mechanical detection Threshold, Mechanical Pain Threshold, Mechanical Pain Sensitivity, Allodynia, Wind-Up Ratio, Vibration Detection Threshold, Pressure Pain Threshold

  • Hospital Anxiety and Depression Score [ Time Frame: 12 months ]

Enrollment: 60
Study Start Date: January 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:
Further study details are provided by Departement V, Odense University Hospital

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
Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital

Inclusion Criteria:

  • Patients for elective lobectomy
  • 18 years or older at the day of the operation
  • Satisfactory abilities to speak and read danish

Exclusion Criteria:

  • Previous Thoracical Surgery.
  • Patients with diseases in the nervous system.
  • Patients with preoperative shoulder pain, neuropathies or sensory disturbances in the arm or shoulder.
  • Patients who are reoperated in the thorax in the study period or any other body-region within the first 4 postoperative days.
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Please refer to this study by its identifier: NCT01552746

Departement V of anesthesia and intensive care, Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital
Vejle Hospital
Principal Investigator: Morten R Eckhardt, MD Departement V of anesthesia and intensive care, Odense University Hospital
  More Information

Responsible Party: Morten Rune Eckhardt, Afdelingslæge, Ph.d.-studerende, Odense University Hospital Identifier: NCT01552746     History of Changes
Other Study ID Numbers: FACTS2
Study First Received: March 2, 2012
Last Updated: June 16, 2014

Keywords provided by Odense University Hospital:
Postoperative shoulder pain
Persisting postoperative pain

Additional relevant MeSH terms:
Shoulder Pain
Joint Diseases
Musculoskeletal Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on April 28, 2017