None listed
Conditions
Brief summary
This study aims to address gaps in the current literature and Australian treatment guidelines for knee osteoarthritis by conducting a high quality randomised control trial to compare the impact of intra-articular botulinum toxin A injections with intra-articular corticosteroid injections on knee pain and function. It is hypothesised that the intra-articular botulinum toxin A injection will significantly reduce knee pain and improve function compared with the intra-articular corticosteroid injection. It is also hypothesised that the intra-articular botulinum toxin A injection group will require less analgesia for knee pain post-injection than the intra-articular corticosteroid injection group. Finally it is hypothesised that there will be no difference in adverse event rate between groups.
Interventions
Intervention group
Intra-articular injection with botulinum toxin A (100 units) reconstituted with 0.9% normal saline (5ml) - once only.
The intra-articular injection will be administered by a radiologist under ultrasound guidance.
Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-injection at outpatient clinic appointments. Patients will be required to complete questionnaires, an adverse event logbook and an analgesia record and bring these to each app
Intervention group Intra-articular injection with botulinum toxin A (100 units) reconstituted with 0.9% normal saline (5ml) - once only. The intra-articular injection will be administered by a radiologist under ultrasound guidance. Patients will be followed up at 2 weeks, 6 weeks, 3 months, 6 months and 12 months post-injection at outpatient clinic appointments. Patients will be required to complete questionnaires, an adverse event logbook and an analgesia record and bring these to each appointment.
Sponsors
Stephanie Babic
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age more than or equal to 40 years. 2. Diagnosis of knee OA confirmed on clinical exam and radiologically by Kellgren-Lawrence Grading Scale (Grade III or IV); 3. Symptoms present for more than or equal to 6 months; and 4. Ability to understand and participate in the trial.
Exclusion criteria
1. Age less than 40 years; 2. Any intra-articular injection within the past 12 months; 3. History of trauma to the knee within the past 12 months; 4. History of surgery to the knee within the past 12 months; 5. Neuromuscular disorders (for example, myasthenia gravis, Lambert-Eaton, amyotrophic lateral sclerosis et cetera); 6. Other knee arthropathy (for example, RA, gout et cetera); 7. Lower extremity dysfunction due to a neurological or medical cause (for example, due to a cerebrovascular accident or traumatic brain injury, diabetic neuropathy et cetera); 8. Serious coagulation disorders or anticoagulant use; and 9. Pregnancy or breastfeeding.
Outcome results
None listed