BACKGROUND: The aim of this study was to evaluate the efficacy and safety of injection of allogeneic growth factors in patients with plantar fasciitis. METHODS: This study included 150 patients who were randomly divided into 2 equal groups; the patients were locally injected with allogeneic growth factors (GFs) (treatment group) or with saline 0.9% (control group). The patients were assessed using visual analog scale (VAS) and Foot Function Index-Revised short form (FFI-Rs) scores preinjection and 1, 3, 6, and 12 months postinjection. The patients were questioned about their satisfaction. Any adverse effects were recorded. RESULTS: At baseline, there was no significant difference between both groups regarding the mean VAS and FFI-Rs scores. At 3-month follow-up, the reduction in mean VAS score was 87% in the treatment group and 55% in the control group (P < .001), and the reduction in mean FFI-Rs score was 62% in the treatment group and 40% in the control group (P < .001). Treatment group and study visit were significant factors affecting both VAS and FFI-Rs scores. Overall, 92% were satisfied in the treatment group, and 78.2% in the control group. Postinjection pain occurred in 5 patients in the treatment group. CONCLUSION: This study provides Level I evidence regarding the efficacy and safety of allogeneic GF injection in patients with plantar fasciitis. However, additional studies are needed to evaluate their adverse effects, immunogenicity, and microbiological safety. LEVEL OF EVIDENCE: Level I, prospective randomized controlled case series.
BACKGROUND: The aim of this study was to evaluate the efficacy and safety of injection of allogeneic growth factors in patients with plantar fasciitis. METHODS: This study included 150 patients who were randomly divided into 2 equal groups; the patients were locally injected with allogeneic growth factors (GFs) (treatment group) or with saline 0.9% (control group). The patients were assessed using visual analog scale (VAS) and Foot Function Index-Revised short form (FFI-Rs) scores preinjection and 1, 3, 6, and 12 months postinjection. The patients were questioned about their satisfaction. Any adverse effects were recorded. RESULTS: At baseline, there was no significant difference between both groups regarding the mean VAS and FFI-Rs scores. At 3-month follow-up, the reduction in mean VAS score was 87% in the treatment group and 55% in the control group (P < .001), and the reduction in mean FFI-Rs score was 62% in the treatment group and 40% in the control group (P < .001). Treatment group and study visit were significant factors affecting both VAS and FFI-Rs scores. Overall, 92% were satisfied in the treatment group, and 78.2% in the control group. Postinjection pain occurred in 5 patients in the treatment group. CONCLUSION: This study provides Level I evidence regarding the efficacy and safety of allogeneic GF injection in patients with plantar fasciitis. However, additional studies are needed to evaluate their adverse effects, immunogenicity, and microbiological safety. LEVEL OF EVIDENCE: Level I, prospective randomized controlled case series.