RESUMEN
Objectives: Plantar heel pain (PHP) is the most common cause of heel pain and can be debilitating; 20% of patients are refractory to standard of care. The Fascial Distortion Model (FDM), a novel manual diagnostic and treatment strategy, is purported to be effective for chronic pain; however, no rigorous studies document its effectiveness. We assessed the FDM for care of PHP. Design: Single arm prospective effectiveness study. Settings/Location: Outpatient primary care clinic; Fort Gordon, GA. Subjects: Outpatient adults. Interventions: Participants received an FDM-informed diagnostic and treatment strategy to identify fascial "distortions" at the foot based on patient-reported pain patterns and palpatory examination and then to provide distortion-specific manual therapy at baseline and 1 week. Outcome Measures: Primary outcome measure (0, 1, and 16 weeks): the Foot Pain subscale on the validated Foot Health Status Questionnaire (FHSQ; 0-100 points on each of eight separate subscales); secondary outcome measures (0, 1, and 16 weeks): the seven remaining subscales on the FHSQ, visual analog pain scale (VAS, 0-100 points), and plantar fascia thickness of the most effected foot assessed by ultrasound (0 and 16 weeks). Analysis was performed per protocol using repeated-measures analysis of variance. Results: One hundred and ninety-seven participants were screened; 33 were enrolled. Twenty-eight participants received two FDM procedures. Compared with baseline, improvement on the FHSQ Foot Pain (33.8-23.6 points) and Foot Function (23.9-19.8 points) subscales and VAS (44.7-27.7 points) at 16 weeks was statistically significant (all p's < 0.001) and clinically important representing large effect sizes. Relative to baseline, 16-week ultrasound demonstrated reduced average plantar fascia thickness (0.6-0.9 mm [p = 0.001]). Demographic characteristics were unrelated to response. Satisfaction was high. There were no serious adverse events; side effects included consistent mild-to-moderate self-limited pain. Conclusions: Participants with PHP who received FDM-informed care reported significant and sustained improvement on validated foot pain and foot function measures; additional findings included decreased plantar fascial thickness. These results require corroboration in a larger randomized controlled study. Clinical Trial Registration No: DDEAMC17005.