None listed
Conditions
Brief summary
There is currently no disease-modifying agents available for knee osteoarthritis and treatment focuses on relief of symptoms such as pain and stiffness. There is limited placebo controlled randomised clinical trial data for a number of procedures to improve symptoms of knee osteoarthritis to improve function. These include steroid injections into the joint and blocking the nerves that supply the joint. These interventions have not been adequately studied against placebo. This study will look at comparing the effectiveness and safety profile of these two technqiues agents against a shared placebo group to see if they are effective. A further exploratory outcome is how well these interventions compare against each other if they prove effective against placebo.
Interventions
All interventions are once-off only
Arm 1: Genicular nerve block
o Ultrasound used to localise superolateral genicular nerve (SLGN), superomedial genicular nerve (SMGN), and inferomedial genicular nerve (IMGN)
o Subcutaneous injection of a total of 1ml of 1% lignocaine at three needle entry points for comfort
o Continuous 22-gauge needle visualization to the nerve bundle using a long-axis approach to guide perineural injections of 5.7 mg celestone chronodose (1 ml) and 0.5% bupivacaine (3 ml)
All interventions are once-off only Arm 1: Genicular nerve block o Ultrasound used to localise superolateral genicular nerve (SLGN), superomedial genicular nerve (SMGN), and inferomedial genicular nerve (IMGN) o Subcutaneous injection of a total of 1ml of 1% lignocaine at three needle entry points for comfort o Continuous 22-gauge needle visualization to the nerve bundle using a long-axis approach to guide perineural injections of 5.7 mg celestone chronodose (1 ml) and 0.5% bupivacaine (3 ml) at three sites. o Introduction of 3ml of normal saline into the intraarticular space of the knee joint under direct visualisation Arm 2: Intraarticular steroid injection: o Visualisation of the knee joint with bedside ultrasound o Subcutaneous injection of a total of 1ml of 1% lignocaine at three points for comfort and sham, one of which is the entry point for intraarticular injection, the other two being sham injections o Introduction of 80mg of methyl-prednisone (2ml) admixed with 1ml of 1% lignocaine to make 3mls into the intraarticular space of the knee joint under direct visualisation
Sponsors
St George Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age >= 18 years • Able to consent • Has readily accessible XRs of the knees of less than 12 months duration • Knee OA as defined by ACR classification criteria • Chronicity of pain as defined by 4 or more on VAS (1-10) on most days for at least 3 months • Kellgren-Lawrence score of II or III • Intraarticular steroid injection to the knee naive
Exclusion criteria
• Inflammatory arthritis • Allergy to intervention compounds • Pregnancy • Cognitive impairment or short term memory loss • Planned orthopaedic surgery within 6 months
Outcome results
None listed