Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery (PSOASS)
Tracking Information | |||||
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First Received Date ICMJE | June 14, 2012 | ||||
Last Updated Date | June 14, 2012 | ||||
Start Date ICMJE | August 2012 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery | ||||
Official Title ICMJE | Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery | ||||
Brief 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. |
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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. |
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Study Type ICMJE | Observational | ||||
Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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Biospecimen | |||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Patients presenting for elective arthroscopic shoulder surgery |
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Condition ICMJE | Anomaly; Shoulder | ||||
Intervention ICMJE | |||||
Study Group/Cohort (s) | PSOASS Patients
Patients undergoing elective arthroscopic shoulder surgery |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE | 200 | ||||
Estimated Completion Date | November 2014 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria: All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent. Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE |
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Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT01621555 | ||||
Other Study ID Numbers ICMJE | PSOASS1 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Tony Davis, NHS Fife | ||||
Study Sponsor ICMJE | NHS Fife | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | NHS Fife | ||||
Verification Date | June 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |