COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery (PSOASS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01621555
Recruitment Status : Unknown
Verified June 2012 by Tony Davis, NHS Fife.
Recruitment status was:  Not yet recruiting
First Posted : June 18, 2012
Last Update Posted : June 18, 2012
Information provided by (Responsible Party):
Tony Davis, NHS Fife

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.

Condition or disease
Anomaly; Shoulder

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery
Study Start Date : August 2012
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

PSOASS Patients
Patients undergoing elective arthroscopic shoulder surgery

Primary Outcome Measures :
  1. Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. • The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting for elective arthroscopic shoulder surgery

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01621555

Layout table for location contacts

Layout table for location information
United Kingdom
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Contact: ANTHONY H DAVIS, MBCHB FRCA    01592 643355 ext 27942   
Sponsors and Collaborators
NHS Fife
Layout table for investigator information
Principal Investigator: ANTHONY H DAVIS, MBCHB FRCA NHS Fife

Layout table for additonal information
Responsible Party: Tony Davis, Dr Anthony Davis, NHS Fife Identifier: NCT01621555    
Other Study ID Numbers: PSOASS1
First Posted: June 18, 2012    Key Record Dates
Last Update Posted: June 18, 2012
Last Verified: June 2012
Keywords provided by Tony Davis, NHS Fife:
shoulder surgery
Pain sensitivity
Rowe score
Constant Score
Surgical Outcome
Postoperative pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Immune System Diseases