Measures of Pain Relevant to Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310257
• Other study ID #: 10052
• Secondary ID: 9227
• Status: Completed
• Phase: N/A
• First received: March 2, 2011
• Last updated: January 16, 2014
• Start date: December 2010
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: University of Nottingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Questionnaires
Patients will be given questionnaires relevant to their condition to complete. In Study 2 and a sub-study of Study 1, patients will be invited to take part in Quantitative Sensory Testing.

Locations

Country	Name	City	State
United Kingdom	Nottingham Country Health Partnerships	Nottingham
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Sherwood Forest Hospitals NHS Trust	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
University of Nottingham	Arthritis Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.	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.	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.	No
Secondary	Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds)	Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and control areas (e.g., healthy contralateral knee).	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.	No

External Links

•   Arthritis Research UK Pain Centre