Measures of Pain Relevant to Knee Osteoarthritis

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Other: Questionnaires

• Registration Number: NCT01310257
• Lead Sponsor: University of Nottingham

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-08
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-16
• Last Update Posted: 2014-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Knee osteoarthritis	Questionnaires	Patients will have osteoarthritis (OA) of the knee defined and scored radiologically in Study 1. Patients in Study 2 will also have OA of the knee, but a clinical diagnosis will suffice. All patients will report knee pain.

Primary Outcome Measures

Name	Time	Method
Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.	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 Outcome Measures

Name	Time	Method
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.	Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and control areas (e.g., healthy contralateral knee).

Trial Locations

Locations (3)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom

Nottingham Country Health Partnerships; 🇬🇧 Nottingham, United Kingdom

Sherwood Forest Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom