Anomaly; ShoulderPSOASSNCT01621555
Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery
An observational study of Anomaly; Shoulder, run by NHS Fife at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anomaly; Shoulder
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Nov 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting for elective arthroscopic shoulder surgery
Who may be able to join
- All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.
Who cannot join
- Unable to give informed consent
- Documented sensory abnormality (e.g. peripheral neuropathy)
- Contraindication to proposed anaesthetic/analgesic regimen
- No telephone or unable to communicate in English
- Documented psychiatric disorder
- Documented/suspected substance abuse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS FIFE
Kirkcaldy, Fife, KY2 5AH
ANTHONY H DAVIS, MBCHB FRCA, 01592 643355 ext. 27942, anthonydavis@nhs.net
About this study
The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.
Read the detailed description
Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.
The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.
- Conditions
- Anomaly; Shoulder
- Keywords
- shoulder surgery, Pain sensitivity, Rowe score, Constant Score, Surgical Outcome, Postoperative pain
- Medical subject headings
- Congenital Abnormalities, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PSOASS Patients | Patients undergoing elective arthroscopic shoulder surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.
Measured: 6 months
Secondary outcomes (2)
The degree of correlation between Pain Sensitivity Questionnaire scores and 'Area Under the Curve (AUC)' for postoperative pain experienced (generated from the VAS scores over 4 postoperative days).
Measured: 6 months
• The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study startAug 2012
- Study completionNov 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anomaly; ShoulderStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Fife
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Tony Davis, NHS Fife
- Investigators
- ANTHONY H DAVIS, MBCHB FRCA, Principal investigator, NHS Fife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621555
- Sponsor's protocol ID
- PSOASS1
- Acronym
- PSOASS
- Status last verified
- Jun 2012
- First submitted
- 14 Jun 2012
- Last updated
- 18 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery
- ClinicalTrials.gov ID
- NCT01621555
- Acronym / sponsor ID
- PSOASS / PSOASS1
- Conditions
- Anomaly; Shoulder
- Keywords
- shoulder surgery, Pain sensitivity, Rowe score, Constant Score, Surgical Outcome, Postoperative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS FifeOther government
- Study start
- Aug 2012
- Study completion
- Nov 2014 (estimated)
- First posted
- 18 Jun 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.
The purpose of this study is to investigate whether there is a correlation between a patients pain sensitivity and their subsequent post-operative pain and surgical outcome in arthroscopic shoulder surgery.
Detailed description
Arthroscopic shoulder surgery is increasingly performed on a daycase basis. Optimal pain relief is the goal as this not only improves patient comfort and allows expedient discharge from hospital, but also reduces the risk of developing postoperative chronic pain and may improve surgical outcome. However, optimal postoperative pain control in daycase surgery remains a challenge. There is considerable variation in the level of postoperative pain experienced between individuals and subsequent analgesia requirements. Previous studies have attempted to predict the level of postoperative pain an individual will experience, using a variety of complex preoperative pain and psychological assessments. Other investigators have focused on a simpler approach, by testing an individual's pain threshold to a single preoperative nociceptive (painful) stimulus, e.g. heat or pressure. Recent work has produced a simple questionnaire alternative to pain intensity testing, the Pain Sensitivity Questionnaire (PSQ). We hypothesise that a patient's pain sensitivity preoperatively may both affect the level of pain they experience postoperatively and their final surgical outcome.
The aim of our study is to correlate a patient's pain sensitivity, as measured by the Pain Sensitivity Questionnaire, with the degree of acute postoperative pain (first 4 days) they experience and subsequent surgical outcome at 6 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSOASS Patients | – | –Patients undergoing elective arthroscopic shoulder surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting for elective arthroscopic shoulder surgery
Key inclusion criteria (1 listed)
- All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.
Key exclusion criteria (6 listed)
- Unable to give informed consent
- Documented sensory abnormality (e.g. peripheral neuropathy)
- Contraindication to proposed anaesthetic/analgesic regimen
- No telephone or unable to communicate in English
- Documented psychiatric disorder
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
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.
Time frame: 6 months
2 secondary outcomes
The degree of correlation between Pain Sensitivity Questionnaire scores and 'Area Under the Curve (AUC)' for postoperative pain experienced (generated from the VAS scores over 4 postoperative days).
Time frame: 6 months
• The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2012.
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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.
ANTHONY H DAVIS, MBCHB FRCA principal investigator
NHS Fife
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 Anomaly; Shoulder, run by NHS Fife at 1 site in United Kingdom.
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 6 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 18 Jun 2012. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ANTHONY H DAVIS, MBCHB FRCA (01592643355 ext. 27942, ANTHONYDAVIS@NHS.NET), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score. (time frame: 6 months). 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 18 Jun 2012.