NCT01621555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

June 18, 2012

Status Verified

June 1, 2012

First QC Date

June 14, 2012

Last Update Submit

June 14, 2012

Conditions

Anomaly; Shoulder

Keywords

shoulder surgeryPain sensitivityRowe scoreConstant ScoreSurgical OutcomePostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Degree of correlation between Pain Sensitivity Questionnaire score and 6 month postoperative Rowe/Constant Score.

    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).

    6 months

  • • The degree of correlation between AUC for postoperative pain and 6 month Constant/Rowe score.

    6 months

Study Arms (1)

PSOASS Patients

Patients undergoing elective arthroscopic shoulder surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting for elective arthroscopic shoulder surgery

You may qualify if:

  • All patients aged 18 years or older, attending for arthroscopic shoulder surgery (stabilisation, rotator cuff repair, arthrolysis, subacromial decompression), able to give informed consent.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS FIFE

Kirkcaldy, Fife, KY2 5AH, United Kingdom

Location

MeSH Terms

Conditions

Congenital AbnormalitiesPain, Postoperative

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • ANTHONY H DAVIS, MBCHB FRCA

    NHS Fife

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ANTHONY H DAVIS, MBCHB FRCA

CONTACT

01592643355ANTHONYDAVIS@NHS.NET

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anthony Davis

Study Record Dates

First Submitted

June 14, 2012

First Posted

June 18, 2012

Study Start

August 1, 2012

Study Completion

November 1, 2014

Last Updated

June 18, 2012

Record last verified: 2012-06

Locations

GB(1)