UP-KNEE study is a feasibility, double-blind, placebo-controlled randomised parallel study in participants with radiographically defined knee OA, and with self-reported chronic knee pain.
Osteoarthritis (OA) of the knee joint is a common cause of chronic pain, disability and impaired quality of life. Knee OA affects \~ 1 in 5 adults over 45 years, with many requiring major knee surgery to alleviate pain and restore mobility. However, \> 1 in 5 patients will continue to suffer from pain despite surgery. It remains largely unknown who will fail to respond, and why. Chronic postoperative pain may be linked to a particular type of pain, that is not only driven by the joint damage itself but by changes in the central nervous system (central pain). Several lines of evidence support this idea, but there is a need for a better understanding of the underlying mechanisms as well as a better tool to differentiate between peripherally- and centrally-augmented knee pain in order to identify who will benefit the most from knee surgery. To this end, the proposed research is a feasibility study aiming to provide proof of concept for a future main trial. The study combines the diagnostic power of non-invasive imaging with experimental approaches to investigate central pain by modelling the peripheral effects of knee surgery. This will provide novel insights into the contribution of peripheral and central pain mechanisms in knee OA which can pave the way for better treatment results. This study is expected to last for one year. It is funded by Versus Arthritis Pain Centre and forms part of a wider scientific project aiming at increasing knowledge and understanding of OA pain.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
50
25 participants will be allocated to the bupivacaine arm.
25 participants will be allocated to the placebo arm.
The change from baseline in pain score during the six-minute walk test
The change from baseline in pain score using the Visual Analogue Scale during the six-minute walk test. (visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)
Time frame: From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo
The change from baseline in pain score at rest
The change from baseline in pain score using the Visual Analogue Scale at rest. (visual analogue scale ranges from 0-100; 0 meaning no pain and 100 worst imaginable pain)
Time frame: From baseline to approximately one hour after intra-articular injection with bupivacaine or placebo
Quantitative sensory testing (QST)
Correlations between change of pain score and QST findings will be assessed.
Time frame: Baseline and within 30 minutes after intra-articular injection with bupivacaine or placebo
Brain functional magnetic resonance imaging (fMRI)
Correlations between the change of pain score and brain network activity using predefined seeds in the pain processing regions will be assessed.
Time frame: Baseline and 1 hour after intra-articular injection with bupivacaine or placebo
Magnetic Resonance Imaging Knee Osteoarthritis Score (MOAKS)
Correlations between the change of pain score and the level of joint damage quantified by MOAKS will be assessed. Higher MOAKS indicate worse outcome.
Time frame: Baseline
The number of eligible participants who are recruited and randomised to the study
To assess the feasibility of recruitment, the number of eligible participants who are recruited and randomised to the study will be measured.
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Time frame: Through study completion, an average of 6 months
A study-specific checklist to assess the feasibility of the randomisation process
Evaluation of effective randomisation of participants to the study arms using a study-specific checklist and assessment of the randomisation protocol throughout the study.
Time frame: Through study completion, an average of 6 months
A study-specific questionnaire to assess the acceptability of the trial methods
A study-specific questionnaire will be administered to participants to assess the acceptability of the study design and research process.
Time frame: Assessed immediately after the final intervention