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

PLoS One. 2019 Feb 22;14(2):e0211999. doi: 10.1371/journal.pone.0211999. eCollection 2019.

Abstract

Objective: 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%.

Methods: 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.

Results: 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.

Conclusion: 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.

Publication types

  • Comparative Study
  • Equivalence Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage*
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use
  • Chondroitin / administration & dosage
  • Chondroitin / therapeutic use
  • Drug Compounding
  • Equipment Design / instrumentation*
  • Glucosamine / administration & dosage
  • Glucosamine / therapeutic use
  • Humans
  • Hyaluronic Acid / administration & dosage
  • Hyaluronic Acid / therapeutic use
  • Knee Injuries / therapy*
  • Magnetic Phenomena
  • Male
  • Middle Aged
  • Pain Measurement
  • Pilot Projects
  • Treatment Outcome

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Hyaluronic Acid
  • Chondroitin
  • Glucosamine

Grants and funding

The trial was funded by OBJ Ltd through a contractural arrangement with UNIQuest. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.