A randomised pilot equivalence trial to evaluate diamagnetically enhanced transdermal delivery of key ground substance components in comparison to an established transdermal non-steroidal anti-inflammatory formulation in males with prior knee injury.
Bill VicenzinoPeter LawrensonAsaduzzaman KhanAiofe StephensonLuke HealesHeather A E BensonAnthony WrightPublished in: PloS one (2019)
The knee guard device demonstrated equivalence for the KOOS-F measure but not the AFS measure of function over the two week trial period when compared to a widely available NSAID gel that has been shown to be superior to placebo. The knee guard produced a greater reduction in pain report (p = 0.002) than the NSAID gel. Users of the knee guard device experienced more skin irritation than participants using the NSAID gel. Further research is required to fully evaluate the therapeutic potential of this innovative treatment approach.
Keyphrases
- total knee arthroplasty
- study protocol
- knee osteoarthritis
- clinical trial
- phase iii
- anterior cruciate ligament
- anterior cruciate ligament reconstruction
- wound healing
- open label
- anti inflammatory
- phase ii
- placebo controlled
- double blind
- randomized controlled trial
- chronic pain
- drug delivery
- pain management
- spinal cord injury
- anti inflammatory drugs
- replacement therapy