Chronic Postoperative PainNCT02924519
Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery
An observational study of Chronic Postoperative Pain, run by University of Aarhus.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Chronic Postoperative Pain
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Oct 2018
- 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 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for ambulatory (outpatient) arthroscopic shoulder surgery
Who may be able to join
- Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).
Who cannot join
- • < 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
About this study
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.
Read the detailed 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.
- Conditions
- Chronic Postoperative Pain
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hours after surgery
Secondary outcomes (7)
Acute postoperative pain
Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain
Measured: 1 week 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
Measured: 3 month after surgery
Preoperative psychological predictors for chronic pain
Hospital Anxiety and Depression Scale (HADS)
Measured: 6 months after surgery
Preoperative psychological predictors for chronic pain
State-Trait Anxiety
Measured: 6 months after surgery
Preoperative psychological predictors for chronic pain
Pain Catastrophizing Scale (PCS)
Measured: 6 months after surgery
Preoperative physical predictors for chronic pain
Cold pressure test
Measured: 6 months after surgery
Preoperative comorbidity
Other places than the shoulder
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startMay 2014
- Primary completionOct 2016 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924519
- Sponsor's protocol ID
- 1-10-72-103-14
- Status last verified
- Aug 2016
- First submitted
- 9 Aug 2016
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Ambulatory Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT02924519
- Acronym / sponsor ID
- 1-10-72-103-14
- Conditions
- Chronic Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Regionshospitalet Horsens
- Study start
- May 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 5 Oct 2016 (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 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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for ambulatory (outpatient) arthroscopic shoulder surgery
Key inclusion criteria (1 listed)
- Arthroscopic shoulder surgery (subacromial decompression and acromioclavicular joint resection).
Key exclusion criteria (8 listed)
- • < 18 years
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
Chronic postoperative pain
Time frame: 6 months after surgery
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
Acute postoperative pain
Time frame: 24 hours after surgery
Measured on a numerical rating scale (NRS; 0=no pain and 10=worst possible pain. NRS>3= acute postoperative pain
7 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postoperative Pain, run by University of Aarhus.
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 1 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Chronic postoperative pain (time frame: 6 months after surgery). 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 5 Oct 2016.