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

Shawn Cazzell, Jordan Stewart, Patrick S. Agnew, John Senatore, Jodi Walters, Douglas Murdoch, Alex Reyzelman, Stuart Miller

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)1151-1161
Number of pages11
JournalFoot and Ankle International
Volume39
Issue number10
DOIs
StatePublished - Oct 1 2018
Externally publishedYes

Fingerprint

Plantar Fasciitis
Chorion
Amnion
Randomized Controlled Trials
Placebos
Injections
Membranes
Visual Analog Scale
Foot
Therapeutics
Safety
Pain Measurement
Sodium Chloride
Pain

Keywords

  • chronic pain
  • dehydrated human amnion/chorion membrane
  • plantar fasciitis

ASJC Scopus subject areas

  • Surgery
  • Orthopedics and Sports Medicine

Cite this

Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis. / Cazzell, Shawn; Stewart, Jordan; Agnew, Patrick S.; Senatore, John; Walters, Jodi; Murdoch, Douglas; Reyzelman, Alex; Miller, Stuart.

In: Foot and Ankle International, Vol. 39, No. 10, 01.10.2018, p. 1151-1161.

Research output: Contribution to journalArticle

Cazzell, Shawn ; Stewart, Jordan ; Agnew, Patrick S. ; Senatore, John ; Walters, Jodi ; Murdoch, Douglas ; Reyzelman, Alex ; Miller, Stuart. / Randomized Controlled Trial of Micronized Dehydrated Human Amnion/Chorion Membrane (dHACM) Injection Compared to Placebo for the Treatment of Plantar Fasciitis. In: Foot and Ankle International. 2018 ; Vol. 39, No. 10. pp. 1151-1161.
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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.",
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AU - Stewart, Jordan

AU - Agnew, Patrick S.

AU - Senatore, John

AU - Walters, Jodi

AU - Murdoch, Douglas

AU - Reyzelman, Alex

AU - Miller, Stuart

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AB - 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.

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