Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis. (October 2018)

• Record Type: Journal Article
• Authors: Cazzell, Shawn; Stewart, Jordan; Agnew, Patrick S.; Senatore, John; Walters, Jodi; Murdoch, Douglas; Reyzelman, Alex; Miller, Stuart D.
• Is Part Of: Foot & ankle international. Volume 39:Number 10(2018)
• Page Start: 1151
• Page End: 1161
• Publication Date: 2018-10
• Subjects: dehydrated human amnion/chorion membrane -- chronic pain -- plantar fasciitis; Foot -- Abnormalities -- Periodicals; Ankle -- Abnormalities -- Periodicals; Orthopedics -- Periodicals; 617.585
• DOI: 10.1177/1071100718788549
• Languages: English
• ISSNs: 1071-1007

Abstract

Background: Failure of conservative management to reduce/eliminate symptoms of plantar fasciitis (PF) may indicate need for advanced treatments. This study reports Level 1 evidence supporting 3-month safety and efficacy of micronized dehydrated human amnion/chorion membrane (dHACM) injection as a treatment for PF. Methods: A prospective, single-blind, randomized controlled trial was conducted at 14 sites in the United States. Subjects were randomized to receive 1 injection, in the affected area, of micronized dHACM (n=73) or 0.9% sodium chloride placebo (n=72). Safety/efficacy assessments were conducted at 4 weeks, 8 weeks, 3 months, 6 months, and 12 months postinjection, using visual analog scale (VAS) for pain, Foot Function Index–Revised (FFI-R) score, and presence/absence of adverse events. Primary outcome was mean change in VAS score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Secondary outcome was mean change in FFI-R score between baseline and 3 months expressed as difference in means for treatment versus control subjects. Results: Baseline VAS scores were similar between groups. At the 3-month follow-up, mean VAS scores in the treatment group were 76% lower compared with a 45% reduction for controls ( P < .0001), FFI-R scores for treatment subjects had mean reduction of 60% versus baseline, whereas control subjects had mean reduction of 40% versus baseline ( P = .0004). Of 4 serious adverse events, none were related to study procedures. Conclusion: Pain reduction and functional improvement outcomes were statistically significant and clinically relevant, supporting use of micronized dHACM injection as a safe and effective treatment for PF. Level of Evidence: Level I, prospective randomized trial.