PainFACTS2NCT01552746
From ACute To Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy
An observational study of Pain, run by Odense University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital
Who may be able to join
- Patients for elective lobectomy
- 18 years or older at the day of the operation
- Satisfactory abilities to speak and read danish
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departement V of anesthesia and intensive care, Odense University Hospital
Odense, 5000
About this study
Official title: From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy
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.
Read the detailed description
Further study details are provided by Departement V, Odense University Hospital
- Conditions
- Pain
- Keywords
- Postoperative shoulder pain, Persisting postoperative pain
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain
Measured: 12 months
Shoulder range of motion
Shoulder range of motion in: flexion, outward rotation, inward rotation, adduction
Measured: 12 months
Secondary outcomes (4)
Thoracical Pain
Measured: 12 months
Presence of allodynia and hyperalgesia on the shoulder on the operated side.
Presence of allodynia and hyperalgesia on the shoulder on the operated side, compared to the contralateral shoulder.
Measured: 1. postoperative day
Quantitative sensory testing values on the shoulder
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
Measured: 12 months
Hospital Anxiety and Depression Score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vejle Hospital
- Responsible party
- Principal investigator, Morten Rune Eckhardt, Odense University Hospital
- Investigators
- Morten R Eckhardt, MD, Principal investigator, Departement V of anesthesia and intensive care, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01552746
- Sponsor's protocol ID
- FACTS2
- Acronym
- FACTS2
- Status last verified
- Jun 2014
- First submitted
- 2 Mar 2012
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- From Acute to Chronic Postoperative Shoulder Pain in Patients for Elective Lobectomy
- ClinicalTrials.gov ID
- NCT01552746
- Acronym / sponsor ID
- FACTS2 / FACTS2
- Conditions
- Pain
- Keywords
- Postoperative shoulder pain, Persisting postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Vejle Hospital
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Further study details are provided by Departement V, Odense University Hospital
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients, scheduled for elective lobectomy of the lung at Odense University Hospital
Key inclusion criteria (3 listed)
- Patients for elective lobectomy
- 18 years or older at the day of the operation
- Satisfactory abilities to speak and read danish
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
4 secondary outcomes
Thoracical Pain
Time frame: 12 months
Presence of allodynia and hyperalgesia on the shoulder on the operated side.
Time frame: 1. postoperative day
Quantitative sensory testing values on the shoulder
Time frame: 12 months
Hospital Anxiety and Depression Score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Morten R Eckhardt, MD principal investigator
Departement V of anesthesia and intensive care, Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.