Efficacy of heel lifts for insertional Achilles tendinopathy (LIFTIT): A randomised feasibility trial.

Objectives: Insertional Achilles tendinopathy is a common and disabling condition. This trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the efficacy of heel lifts compared to a sham intervention for reducing pain intensity associated with insertional Achilles tendinopathy.

Methods: Twenty-six people with insertional Achilles tendinopathy were randomised to either the heel lift group or sham intervention group. Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events and retention. Limited efficacy testing was conducted on secondary outcome measures including pain intensity, function, physical activity, health-related quality of life, use of co-interventions and global rating of change.

Results: Between August 25, 2023, and April 7, 2024, we recruited and tested 26 participants (aged 28-65 years, mean [SD] 51 [8]). The pre-determined thresholds were met for demand, acceptability, adherence, retention, pain intensity, function, quality of life and global rating of change and partly met for adverse events, physical activity and use of co-interventions. Between 47 and 241, participants will be needed for a fully powered randomised trial.

Conclusion: In its current form, a randomised trial of heel lifts compared to a sham intervention is feasible. However, future triallists may need to consider strategies to manage the risk of adverse events and plan to adjust the analyses to account for the use of co-interventions.

Trial Registration: ACTRN12623000721606.