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Measures of Pain Relevant to Knee Osteoarthritis

Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01310257
Enrollment
448
Registered
2011-03-08
Start date
2010-12-31
Completion date
2013-09-30
Last updated
2014-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

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.

Interventions

OTHERQuestionnaires

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.

Sponsors

Arthritis Research UK
CollaboratorOTHER
University of Nottingham
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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).

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026