Journal Article

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

Lawrenson, Peter, Wright, Anthony, Khan, Asaduzzaman, Vicenzino, Bill, Stephenson, Aiofe, Heales, Luke, Benson, Heather A. E.

2019

Overview

This pilot study assessed the efficacy of a knee guard device, which used magnetophoresis to transdermally deliver Glucosamine, Chondroitin and Hyaluronic Acid in a cohort of individuals with prior knee injury. The aim was to determine if the change in physical function and pain with the knee guard device was equivalent to the change produced by an established topical NSAID formulation containing diclofenac sodium 1%. A randomized, controlled, equivalence trial evaluated outcomes following treatment with the knee guard device or NSAID formulation. The study recruited 114 male participants (aged 40-55 years). Participants were randomly allocated to wear the knee guard device or to use a NSAID gel daily for two weeks. The primary outcomes were the knee injury osteoarthritis function score (KOOS-F) and an aggregated function score (AFS). The lower extremity functional scale (LEFS), pain numerical rating scale (PNRS), global rating of change (GROC) and other KOOS scores were also evaluated. Multiple linear regression analyses indicated that there were no significant differences between the interventions for changes in the primary outcomes of AFS and KOOS_F. The 95% confidence interval (-2.89 to 5.15) of the estimated treatment difference for KOOS-F was within the lower (-5.61) and upper (5.61) bounds of the 7% equivalence margin for that measure, The mean value for the AFS was within, but the 95% CI (-3.11 to 7.37) exceeded the 7% equivalence margin (-2.97 to 2.97) for that measure. There was a significant difference in PNRS, which favored the knee guard device. 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.

• Publisher: Public Library of Science,Public Library of Science (PLoS)
• Subject: Acids / Adult / Analysis / Anti-inflammatory agents / Anti-Inflammatory Agents, Non-Steroidal - administration & dosage / Anti-Inflammatory Agents, Non-Steroidal - therapeutic use / Arthritis / Bioavailability / Biocompatibility / Biology and Life Sciences / Biomedical materials / Care and treatment / Chondroitin / Chondroitin - administration & dosage / Chondroitin - therapeutic use / Clinical trials / Confidence intervals / Control methods / Development and progression / Diamagnetism / Diclofenac / Dosage and administration / Drug Compounding / Drug delivery / Duloxetine / Equipment Design - instrumentation / Equivalence / Exercise / Glucosamine / Glucosamine - administration & dosage / Glucosamine - therapeutic use / Humans / Hyaluronic acid / Hyaluronic Acid - administration & dosage / Hyaluronic Acid - therapeutic use / Inflammation / Injuries / Irritation / Knee / Knee injuries / Knee Injuries - therapy / Magnetic fields / Magnetic Phenomena / Male / Males / Medical innovations / Medicine and Health Sciences / Metabolism / Middle Aged / Nonsteroidal anti-inflammatory agents / Nonsteroidal anti-inflammatory drugs / Osteoarthritis / Pain / Pain management / Pain Measurement / Patient outcomes / Peptides / Pharmaceuticals / Pharmacy / Physical fitness / Physical Sciences / Physical therapy / Pilot Projects / Prevalence studies (Epidemiology) / Randomization / Regression analysis / Rehabilitation / Research and Analysis Methods / Skin / Sodium / Statistical analysis / Topical analgesics / Transdermal drug delivery systems / Transdermal medication / Treatment Outcome