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Orthotic

Custom PFO orthosis for Plantar Fibroma

N/A
Waitlist Available
Research Sponsored by University of Puget Sound
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be able to tolerate the physical examination and treatment procedures, have symptoms greater than four weeks, able to read, write, and speak sufficient English to be able to complete the outcome tools, plus two of three of the following: symptom reproduction with palpation of the proximal plantar fascia insertion and/or mid substance of plantar fascia, positive Windlass test and/or first step pain after period of inactivity
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 wks, 4 wks, 12 weeks, 6 months
Awards & highlights

Study Summary

The aim of this randomized control trial is to identify the possible effectiveness of the temporary use of an inexpensive, custom-made plantar fascia orthotic (PFO).

Eligible Conditions
  • Plantar Fibroma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 wks, 4 wks, 12 weeks, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 wks, 4 wks, 12 weeks, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Foot Ankle Ability Measure (FAAM) to measure change from Baseline at 4 time frames
Secondary outcome measures
Global Rating of Change (GRC) to measure perceived change at 4 follow-up periods
Other outcome measures
Numeric Pain Rating Scale (NPRS) to measure change from baseline at 4 different time frames

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Custom PFO orthosisExperimental Treatment1 Intervention
This is a custom made orthosis
Group II: Faux foot orthosisPlacebo Group1 Intervention
Foam insert without arch support

Find a Location

Who is running the clinical trial?

University of Puget SoundLead Sponsor
4 Previous Clinical Trials
147 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment
Robert Boyles 2013. "Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01882894.
All > Plantar Fasciitis
~5 spots leftby Apr 2025
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