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Foot & Ankle

Pilot randomised controlled trial of platelet-rich plasma versus normal saline for plantar fasciitis

British Orthopaedic Foot & Ankle Society (BOFAS) November 2016



Abstract

Platelet rich plasma has been advocated for the treatment of plantar fasciitis but there are few good quality clinical trials to support its use. We report a pilot double blind randomised controlled trial of platelet rich plasma versus normal saline.

Methods

Patients with more than 6 months of MRI proven plantar fasciitis who had failed conservative management were invited to participate in this study. Patients were block randomised to either platelet rich plasma injection (intervention) or equivalent volume of normal saline (control). The techniques used for the injection and rehabilitation were standardised for both groups. The patient and independent assessor were blinded. Visual analogue scale for pain (VAS) and painDETECT were recorded pre-op and at 6 months.

Results

Twenty-eight patients (19 females, mean age 50 years) were recruited, with 14 randomised to each arm. At 6 month follow-up, 8 patients (28.6%) were lost to follow-up. There was a significant change in VAS score from baseline to follow-up in both intervention (mean change 37.2, p = 0.008) and control (mean change 42.2, p = 0.003) groups. However there was no difference between the arms in terms of the change in VAS score from baseline to follow-up (p = 0.183). There was no correlation between pre-op PainDETECT score and change in VAS.

Conclusion

This pilot study has failed to show a significant benefit of platelet rich plasma compared to saline injection, although both treatments have shown a significant improvement in symptoms. This may be due to the needling effect of injections. A larger study is required to demonstrate a meaningful change. Loss to follow in this patient group should be considered.