Clinical trial NCT01310257: Measures of Pain Relevant to Knee Osteoarthritis
Official title: Evaluation of Questionnaire Measures for Patients With Osteoarthritis of the Knee
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of the Knee
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: Arthritis Research UK
First posted: 2011-03-08
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.


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

Primary outcomes:
measure: Questionnaire set assessing physical symptoms, cognitive and emotional factors, and quality of life in knee OA.
timeFrame: 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.
Secondary outcomes:
measure: Quantitative Sensory Testing assessing pain and sensory thresholds for a noxious stimulus (Pain Pressure Thresholds)
timeFrame: 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.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Country Health Partnerships
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Nottingham
country: United Kingdom
facility: Sherwood Forest Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: Bryan Moreton
role: PRINCIPAL_INVESTIGATOR
References: