Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment
1 other identifier
interventional
60
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2013
CompletedFirst Posted
Study publicly available on registry
June 21, 2013
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 21, 2013
June 1, 2013
7 months
June 17, 2013
June 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Foot Ankle Ability Measure (FAAM) to measure change from Baseline at 4 time frames
The FAAM has been shown to be a valid and reliable self-reported outcome measure of lower leg, ankle, and foot function of a range of musculoskeletal disorders in a physical therapy setting
Baseline, 2wks, 4 wks, 12 wks, 6 months
Secondary Outcomes (1)
Global Rating of Change (GRC) to measure perceived change at 4 follow-up periods
2 wks, 4 wks, 12 weeks, 6 months
Other Outcomes (1)
Numeric Pain Rating Scale (NPRS) to measure change from baseline at 4 different time frames
Baseline, 2 wks, 4 wks, 12 wks and 6 months
Study Arms (2)
Custom PFO orthosis
EXPERIMENTALThis is a custom made orthosis
Faux foot orthosis
PLACEBO COMPARATORFoam insert without arch support
Interventions
PFO made out of thermoplastic material molded to the patient's foot
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- current symptoms consistent with a lumbar radiculitis, radiculopathy, or myelopathy, history of foot or ankle fracture with or without the presence of hardware from an open reduction internal fixation, positive tarsal tunnel syndrome test, known or suspected pregnancy, and systemic Rheumatic disease, or those undergoing litigation for any medical condition.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Puget Sound
Tacoma, Washington, 98416, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
June 17, 2013
First Posted
June 21, 2013
Study Start
September 1, 2013
Primary Completion
April 1, 2014
Study Completion
December 1, 2014
Last Updated
June 21, 2013
Record last verified: 2013-06