%0 Journal Article %A William McNamara %A Thomas Longworth %A Joo Y Sunwoo %A Syed MT Rizvi %A Christopha J Knee %A Brandi F Cole %T Treatment of medial tibial stress syndrome using an investigational lower leg brace. A pilot for a randomised controlled trial. %D 2023 %R 10.1136/bmjinnov-2022-001054 %J BMJ Innovations %P bmjinnov-2022-001054 %X Objective Medial tibial stress syndrome (MTSS) is common and often difficult to treat. The purpose of this study was to examine the effect of a lower leg brace on MTSS symptoms compared to a placebo.Methods A pilot of a prospective double-blinded randomised placebo-controlled trial conducted in two private sports medicine practices. Included were those with symptomatic MTSS lasting 6 weeks or more. Excluded were those with other lower limb pathologies. Fourteen participants formed the study cohort who wore the brace or placebo. The brace applied counterforce pressure to the musculotendinous junctions of the soleus, compressed periosteum at the distal third of the posteromedial tibia and applied inferomedial torsion to the soleus muscle. Additional treatment modalities were recorded. Participants completed a standardised MTSS Severity Score at 0–6, 8, 12 and 24 weeks and recorded return to full activity.Results The brace group demonstrated a significantly reduced MTSS severity score from 5 to 24 weeks (p<0.03) and had returned to full activity within 5 weeks. MTSS score in the placebo group remained unchanged (p >0.05), all participants experienced MTSS recurrence and none returned to full activity over 24 weeks.Conclusion The lower leg brace demonstrated a reduction in MTSS symptoms from 5 weeks that was sustained over 6 months with a lower rate of MTSS recurrence compared with the placebo. If similar results are seen in a larger cohort, it has potential to benefit patients with MTSS as an adjunct to current treatment modalities. Further investigation regarding efficacy is needed.Trial registration number ACTRN12620000906954. %U https://innovations.bmj.com/content/bmjinnov/early/2023/04/27/bmjinnov-2022-001054.full.pdf