Treatment of Medial Tibial Stress Syndrome using an Investigational Lower Leg Device. A Randomised Controlled Trial.
Authors: William J McNamara MD, Thomas Longworth MBBS, Joo Y Sunwoo MD, Syed SMT Rizvi, Christopha J Knee, Patrick Lam MD PhD, Brandi Cole MBBS PhD.
Objective: Medial tibial stress syndrome is common and often difficult to treat. The purpose of this study was to examine the effect of an investigational device on MTSS symptoms compared to a placebo.
Design: A prospective double-blinded randomised placebo-controlled trial.
Setting: The study was conducted in two private sports medicine practices.
Participants: Included were those with symptomatic MTSS lasting 6 weeks or more. Excluded were those with other lower limb or systemic pathologies. Fourteen participants formed the study cohort.
Interventions: Participants were required to wear the devices daily for up to 2hrs, before and after exercise. Additional treatment modalities were recorded.
Main Outcome Measures: Participants completed a standardised MTSS Severity Score at the initial assessment and 1-6, 8, 12, and 24 weeks.
Results: Comparison of scores between groups from 5-24 weeks demonstrated a significantly lower score in the device group (p < 0.03). Comparison within the placebo group did not demonstrate a statistically significant difference at any time point (p > 0.05) and the device group yielded a significant reduction in MTSS severity from 0-5 weeks (p < 0.03), 0 to 12 weeks (p < 0.03), and 0-24 weeks respectively (p < 0.03). Ordinal logistic regression analysis did not identify any significant confounders.
Conclusion: The investigational device demonstrated a significant reduction in MTSS symptoms from 5 weeks that was sustained over 6 months compared to the placebo. Clinically, it has potential to benefit patients with MTSS as a useful adjunct to current treatment modalities. Further investigation regarding efficacy is indicated.
Note: Results were presented at the 2019 ASICS Sports Medicine Australia Conference in the Foot & Ankle Papers session. Pending publication in a clinical journal.
Treatment of Reduced Ankle Range of Motion using an Investigational Lower Leg Device.
Authors: William J McNamara MD, Joo Y Sunwoo MD, Benjamin JR Lindsay, Rosa M Miller, Genevieve SE Ho, Brandi Cole MDDS PhD.
Introduction:Medial tibial stress syndrome (MTSS) is a common and frustrating overuse injury for patients and clinicians that can be difficult to treat. Reduced ankle range of motion (ROM) secondary to soleus muscle tightening is a well-established risk factor. The purpose of this study was to determine if an investigational device affected ankle ROM as defined by a knee to wall test.
Methods:Participants were prospectively randomised to wear the investigational device on one leg. The contralateral leg was used as a control. Participants were included in this study if they did not exhibit any lower limb pathology. Participants underwent a standardised tape-measure knee to wall test bilaterally. Participants wore the device for one hour whilst being allowed to rest or complete light exercise. After one hour, the device was removed and the knee to wall test was repeated bilaterally. The device resembled a sleeve with three rubber ellipsoids compressing the musculotendinous junctions of the soleus.
Results:The study cohort consisted of 16 male and 14 female participants of with a mean age of 24 ±0.5 years. The mean pre-test ankle ROM for the device leg was 9.85cm ± 0.8cm (range 5 – 13.5cm) and the mean post-test ankle ROM was 11.63cm ± 0.7cm (range 8.3 – 16cm). This represented an average improvement of 21% (p < 0.0001). The mean pre-test ankle ROM for the control leg was 9.25cm ± 0.74cm (range 4 – 12cm) and the mean post-test ankle ROM was 9.5cm ± 0.8 cm (range 4 – 12cm). Ankle ROM improved by 3%, however, this difference was not statistically significant (p > 0.05). When comparing ankle ROM improvement between groups the device group had a significantly greater improvement (p < 0.0001) despite a statistically similar pre-test result (p > 0.05).
Discussion:The investigational device demonstrated significantly improved ankle ROM after one hour of use compared to the control.Clinically it has potential, as an adjunct, to benefit several lower limb disorders where improving ankle ROM can reduce symptoms or play a role in preventing or slowing disease pathophysiology. A limitation of this study is a lack of long-term observation of ankle ROM. Further investigation regarding efficacy is indicated.
Note: Results were presented at the 2019 ASICS Sports Medicine Australia Conference in the poster presentation session. Pending publication in a clinical journal.