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Clinical Trials/NCT03378440
NCT03378440
Completed
Not Applicable

Psychosocial Predictors of Poor Outcomes After a Knee Arthroplasty: Prospective Observational Study.

University of Barcelona1 site in 1 country115 target enrollmentDecember 17, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis, Knee
Sponsor
University of Barcelona
Enrollment
115
Locations
1
Primary Endpoint
Disability / Limitations
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this study is to explore the association between the psychosocial variables: pain catastrophizing, fear of movement, coping skills, pain attitudes, anxiety and depression with postoperative outcomes (pain, health functioning, physical performance, and quality of life) after a knee arthroplasty (KA). The prevalence of KA has increased dramatically during the last two decades, its popularity can be attributed to its evident success regarding pain improvement, deformity correction and disability reduction in knee osteoarthritis subjects. However, only a third of the patients report no functional problems after surgery, the 20% of them are unsatisfied with its functional skills and around a 20% are experiencing pain, high disability degrees and a significant quality of life reduction. This results cannot be fully explained by mechanical processes, surgical procedures or surgery variations, but seems to be related to other psychological aspects. Chronic pain subjects often develop maladaptive thoughts and behaviours (i.e. pain catastrophism, kinesiophobia, activity avoidance) which contribute to make the subject suffer physically as well as emotionally, and affect on the intensity and persistency of pain.

This study is a single centre, prospective observational study of subjects undergoing primary KA. The study is designed and aimed to examine the relationship between postoperative psychosocial factors and the development of post-operative persistent pain and disability.

Registry
clinicaltrials.gov
Start Date
December 17, 2018
End Date
September 8, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Marc Terradas Monllor

Marc Terradas-Monllor, PhD Student

University of Barcelona

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Disability / Limitations

Time Frame: Change from baseline to 1, 3 and 6 months after surgical intervention

Western Ontario and McMaster University Osteoarthritis Index (WOMAC) (Spanish version) will be used to assess patient´s physical function. This questionnaire can be completed in less than 5 minutes. It's a widely used, reliable, valid and responsive measure of outcome in people with osteoarthritis of the hip or knee.

Self-reported Pain

Time Frame: Change from baseline to 1, 3 and 6 months after surgical intervention

Participants will be asked to rate their pain at resting, walking and flexing their knee on a horizontal 100-mm Visual Analogue Scale (VAS). The horizontal line anchors will be "no pain" and "worst imaginable pain". The VAS is a valid and reliable instrument compared with other pain rating scales, and has been well established in clinical practice and research for measuring pain levels in arthritis populations.

Secondary Outcomes

  • Self-reported Quality of life(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Range of Motion(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Kinesiophobia(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Pain Attitudes(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Walking Speed(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Depression and anxiety(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Function(1 week, 1 month, 3 months and 6 months after surgical intervention)
  • Pain Catastrophism(1 week, 1 month, 3 months and 6 months after surgical intervention)

Study Sites (1)

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