Extracorporeal shock wave therapy versus corticosteroid injection for chronic plantar fasciitis: A protocol of randomized controlled trial

BACKGROUND: The outcomes of corticosteroid injection (CSI) and extracorporeal shock wave therapy (ESWT) as primary treatment of plantar fasciitis have been debated. This study was conducted to compare and evaluate the therapeutic effects of ultrasound-guided CSI versus medium frequency ESWT in the treatment of plantar fasciitis among Chinese population. METHODS: This study was a single-center, randomized, and double-blinded trial. The study protocol was approved by local ethics committee board and subsequently registered in Research Registry. Eighty patients with unilateral plantar fasciitis were randomized to receive either ESWT (3 times once per week) (n = 40) or CSI treatment (a single 1-mL dose of betamethasone sodium plus 0.5 mL of prilocaine under ultrasound guidance by injection into the plantar fascia) (n = 40). The primary outcome measures were visual analog scale and Foot Function Index scores. Secondary outcome measures included the heel tenderness index score and plantar fascia thickness as obtained by ultrasound examination. All of the assessments were performed at baseline and 1, 3, and 6 months after treatment. RESULTS: This is a randomized controlled trial evaluating the efficacy of CSI versus ESWT in the treatment of plantar fasciitis. This study has limited inclusion and exclusion criteria and a well-controlled intervention. CONCLUSIONS: The results of this trial will provide more evidence on which method can better treat plantar fasciitis. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5428).