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

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.

Comparison of measures of large-fiber nerve function in patients with chronic nerve compression and neuropathy.

Measurement of large-fiber peripheral nerve function is critical to the assessment of patients with nerve injury, chronic nerve compression, and neuropathy. We evaluated the Semmes-Weinstein nylon monofilament (SWM), vibrometry, and the Pressure-Specified Sensory Device (PSSD) (Sensory Management Services LLC, Baltimore, Maryland) prospectively on the plantar surface of the hallux, bilaterally, in 35 patients with peripheral nerve problems related to nerve compression and neuropathy. Five patients had carpal tunnel syndrome and, therefore, had normal hallux measurements. Normative data for the SWM were obtained for 59 age-stratified people. A moderately strong Pearson product moment correlation was found for large-fiber nerve function between the PSSD and the SWM and between the PSSD and vibrometry. However, when these functions were compared with normative values for each neurosensory testing technique, sensitivity for detecting the presence of a peripheral nerve problem was 100% for the PSSD, 63% for the SWM, and 30% for vibrometry. False-positive test results were obtained for the hallux in 0% of normal feet when the PSSD was used, in 20% when vibrometry was used, and in 30% when the SWM was used as the test instrument. The PSSD was the most sensitive in identifying the presence of a large-fiber peripheral nerve problem in patients with pain or paresthesia in the foot related to the posterior tibial nerve.