Objectives: To compare the clinical effectiveness of focused extracorporeal shockwave therapy (fESWT) and prefabricated insoles among patients suffering from plantar fasciitis (PF).

Study design: Pragmatic randomized open-label trial.

Setting: Rehabilitation Medicine outpatient clinic at a medical school hospital in Bangkok, Thailand.

Subjects: Patients suffering from subacute or chronic PF.

Methods: Participants were randomly allocated (1:1) to receive either 3 weekly sessions of fESWT (2,000 shocks/session of at least 0.2 mJ/mm2) or to wearing prefabricated insoles. All participants were advised to perform stretching of the plantar fascia and gastrocnemius muscle. The clinical outcome measured was an improvement in Foot Function Index (FFI) at 12 weeks. An analysis was done based on the intention-to-treat principle.

Results: Twenty-nine participants were enrolled and randomly assigned to either the fESWT (n = 14) or the insole group (n = 15). A mean and standard deviation (SD) of the improvement in total FFI at 12 weeks was 65 (25.8) points for fESWT and 65.2 (39.2) points for prefabricated insoles with an adjusted mean difference between two interventions of 14.9 (95%CI: -15.4 to 45.2).

Conclusions: The fESWT did not improve FFI compared with prefabricated insoles among patients with subacute and chronic plantar fasciitis. However, the results should be interpreted with caution because of inadequate statistical power.