Measures of Pain Relevant to Knee Osteoarthritis
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Osteoarthritis of the Knee |
Other: Questionnaires |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Cross-Sectional |
| Official Title: | Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee |
- 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. ] [ Designated as safety issue: No ]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.
- Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds) [ 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. ] [ Designated as safety issue: No ]Pain and sensory thresholds will be reported for the affected area (i.e., OA knee) and control areas (e.g., healthy contralateral knee).
| Estimated Enrollment: | 500 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Knee osteoarthritis
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
We aim to recruit a cross section of participants covering a broad spectrum of people with OA of the knee. Community participants will be identified from a cohort of patients who have already agreed to be contacted about future research studies. Additional participants will be identified from clinics at Nottingham University Hospitals and Sherwood Forest Hospitals NHS Foundation Trust, GP surgeries in the local area and patients on a knee OA pathway from Nottingham Healthcare partnership. These sources of recruitment will include those attended rheumatology and orthopaedic specialist clinics for knee OA and rheumatology outpatients at the Queens Medical Centre (QMC)
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
Contacts and Locations| Contact: Bryan J Moreton, PhD | 0115 846 6545 | bryan.moreton@nottingham.ac.uk |
| United Kingdom | |
| Nottingham University Hospitals NHS Trust | Recruiting |
| Nottingham, United Kingdom | |
| Contact: Nadina Lincoln 0115 9515315 | |
| Sherwood Forest Hospitals NHS Trust | Recruiting |
| Nottingham, United Kingdom | |
| Contact: David Walsh 0115 823 1766 | |
| Nottingham Country Health Partnerships | Recruiting |
| Nottingham, United Kingdom | |
| Contact: Bryan Moreton 0115 846 6545 | |
| Principal Investigator: | Bryan Moreton | University of Nottingham |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Nottingham |
| ClinicalTrials.gov Identifier: | NCT01310257 History of Changes |
| Other Study ID Numbers: | 10052, 9227 |
| Study First Received: | March 2, 2011 |
| Last Updated: | October 4, 2012 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Osteoarthritis Osteoarthritis, Knee Arthritis |
Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013