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Clinical Trials/NCT01310257
NCT01310257
Completed
Not Applicable

Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee

University of Nottingham3 sites in 1 country448 target enrollmentDecember 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Osteoarthritis of the Knee
Sponsor
University of Nottingham
Enrollment
448
Locations
3
Primary Endpoint
Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

The aim is to improve understanding of the assessment of pain experience in patients with osteoarthritis (OA) of the knee. The current study will be divided into two parts. In Study 1, the investigators will analyse existing questionnaires relevant to the mechanisms and therapeutic targets of knee OA to establish discrete dimensions that discriminate between the different mechanisms of pain. On the basis of this analysis, the investigators will refine the questionnaires to maximise their sensitivity to knee OA. In Study 2, the investigators will seek to confirm the factor structure identified in the questionnaires in Study 1 and explore potential mediator and moderator variables between pain and quality of life using the refined measures. The investigators will also evaluate Quantitative Sensory Testing as a predictor of OA knee pain.

Registry
clinicaltrials.gov
Start Date
December 2010
End Date
September 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Participants in Study 1 will have OA of the knee defined and scored radiologically and will report knee pain. Participants in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice.

Exclusion Criteria

  • Inability to speak or understand English
  • Under the age of 18 years old
  • knee joint surgery within three months prior to participation
  • Diagnosed Rheumatoid Arthritis, Psoriatic Arthritis, Gout or any other inflammatory arthritis disorder
  • The participants in Study 2 will also be excluded if they participated in Study 1

Outcomes

Primary Outcomes

Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.

Time Frame: Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee. All patients will be assessed at enrollment into the study.

Patients will be given a questionnaire set assessing pain (nociceptive and neuropathic), anxiety, depression, fatigue, illness belief, pain self-efficacy, coping, helplessness and quality of life, associated with OA of the knee. The psychometric properties of the questionnaire set will be reported, including results from Rasch Analysis, Cronbach's Alpha and results from Factor Analysis.

Secondary Outcomes

  • Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds)(Patients will be assessed after diagnosis of OA of the knee. There is no specific time point after diagnosis, because we are interested in a broad spectrum of patients with OA of the knee.)

Study Sites (3)

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