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Ultrasound guided injection of dexamethasone versus placebo for treatment of plantar fasciitis: Protocol for a randomised controlled trial

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journal contribution
posted on 28.05.2021, 01:59 by AM McMillan, Karl LandorfKarl Landorf, Mark GilheanyMark Gilheany, Adam BirdAdam Bird, AD Morrow, Hylton MenzHylton Menz
Background: Plantar fasciitis is the most commonly reported cause of chronic pain beneath the heel. Management of this condition commonly involves the use of corticosteroid injection in cases where less invasive treatments have failed. However, despite widespread use, only two randomised trials have tested the effect of this treatment in comparison to placebo. These trials currently offer the best available evidence by which to guide clinical practice, though both were limited by methodological issues such as insufficient statistical power. Therefore, the aim of this randomised trial is to compare the effect of ultrasound-guided corticosteroid injection versus placebo for treatment of plantar fasciitis.Methods: The trial will be conducted at the La Trobe University Podiatry Clinic and will recruit 80 community-dwelling participants. Diagnostic ultrasound will be used to diagnose plantar fasciitis and participants will be required to meet a range of selection criteria. Participants will be randomly allocated to one of two treatment arms: (i) ultrasound-guided injection of the plantar fascia with 1 mL of 4 mg/mL dexamethasone sodium phosphate (experimental group), or (ii) ultrasound-guided injection of the plantar fascia with 1 mL normal saline (control group). Blinding will be applied to participants and the investigator performing procedures, measuring outcomes and analysing data. Primary outcomes will be pain measured by the Foot Health Status Questionnaire and plantar fascia thickness measured by ultrasound at 4, 8 and 12 weeks. All data analyses will be conducted on an intention-to-treat basis.Conclusion: This will be a randomised trial investigating the effect of dexamethasone injection on pre-specified treatment outcomes in people with plantar fasciitis. Within the parameters of this protocol, the trial findings will be used to make evidence-based recommendations regarding the use of corticosteroid injection for treatment of this condition.Trial Registration: Australian New Zealand Clinical Trials Registry. ACTRN12610000239066. © 2010 McMillan et al; licensee BioMed Central Ltd.

Funding

This study is funded by the Australian Podiatry Education and Research Foundation (APERF). AMM is currently an Australian Postgraduate Award scholarship holder. HBM is currently a National Health and Medical Research Council fellow (Clinical Career Development Award, ID: 4333049). Consumables used in the trial have been donated by Briggate Medical Company (Victoria 3195, Australia).

History

Publication Date

16/07/2010

Journal

Journal of Foot and Ankle Research

Volume

3

Issue

1

Article Number

ARTN 15

Pagination

8p.

Publisher

BMC

ISSN

1757-1146

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