Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery (PSOASS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2012 by NHS Fife
Sponsor:
Information provided by (Responsible Party):
Tony Davis, NHS Fife
ClinicalTrials.gov Identifier:
NCT01621555
First received: June 14, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
  Purpose

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
Anomaly; Shoulder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pain Sensitivity and Outcome in Arthroscopic Shoulder Surgery

Further study details as provided by NHS Fife:

Primary Outcome Measures:
  • Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • • The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2012
Estimated Study Completion Date: November 2014
Groups/Cohorts
PSOASS Patients
Patients undergoing elective 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting for elective arthroscopic shoulder surgery

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621555

Contacts
Contact: ANTHONY H DAVIS, MBCHB FRCA 01592643355 ext 27942 ANTHONYDAVIS@NHS.NET

Locations
United Kingdom
NHS FIFE Not yet recruiting
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Contact: ANTHONY H DAVIS, MBCHB FRCA    01592 643355 ext 27942    anthonydavis@nhs.net   
Sponsors and Collaborators
NHS Fife
Investigators
Principal Investigator: ANTHONY H DAVIS, MBCHB FRCA NHS Fife
  More Information

No publications provided

Responsible Party: Tony Davis, Dr Anthony Davis, NHS Fife
ClinicalTrials.gov Identifier: NCT01621555     History of Changes
Other Study ID Numbers: PSOASS1
Study First Received: June 14, 2012
Last Updated: June 14, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Fife:
shoulder surgery
Pain sensitivity
Rowe score
Constant Score
Surgical Outcome
Postoperative pain

ClinicalTrials.gov processed this record on July 29, 2014