SPOK
Research type
Research Study
Full title
Sources of Pain in Osteoarthritis of the Knee (SPOK)
IRAS ID
260194
Contact name
Philip G Conaghan
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This is a cross-sectional, observational study of patients with knee osteoarthritis (OA) which aims to determine associations between structural features of the knee and knee pain in patients with knee OA, through ultrasound, supine MRI(while lying on their back) and upright MRI. We also aim to establish any major differences between supine and weight-bearing MR images in patients with osteoarthritis. Currently evidence is limited in demonstrating the association between the structural abnormalities in knee OA and pain symptoms experienced by the patient.
We intend to recruit 100 patients aged over 18 with knee OA, diagnosed radiographically in the last 24 months. Patients should also have knee pain (with a pain score score ≥4 and ≤9 on a visual analogue scale) on the majority of days in the last 3 months. 30 Healthy control participants will also be recruited, who have no knee pain.
Patients will be counselled about the study on first visit where a patient information sheet about the study will be given to them. At the second visit informed consent will be obtained. The patient will be checked against a list of inclusion and exclusion criteria to ensure participation in the study is valid. Patients will then be examined and blood tests taken. At the third visit, patients will complete a questionnaire regarding their symptoms. They will also have an ultrasound scan performed of their affected knee along with a supine MRI scan of their knee. A safety checklist will ensure there is no contraindication to an MRI scan. A fourth visit will involve scanning the patient's knee on an upright MRI machine in order to obtain weight bearing MRI images of the patient's knee. Data collected throughout the visits will be analysed with the help of medical statisticians with the intention of publishing findings in a peer-reviewed journal.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0205
Date of REC Opinion
14 Aug 2019
REC opinion
Further Information Favourable Opinion