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Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01882894
Recruitment Status : Unknown
Verified June 2013 by Robert Boyles, University of Puget Sound.
Recruitment status was:  Not yet recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
Robert Boyles, University of Puget Sound

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).

Condition or disease Intervention/treatment Phase
Plantar Fasciitis Device: Custom PFO Other: Faux orthosis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment: A Randomized Controlled Trial.
Study Start Date : September 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

Arm Intervention/treatment
Experimental: Custom PFO orthosis
This is a custom made orthosis
Device: Custom PFO
PFO made out of thermoplastic material molded to the patient's foot

Placebo Comparator: Faux foot orthosis
Foam insert without arch support
Other: Faux orthosis
Foam cut out

Primary Outcome Measures :
  1. Foot Ankle Ability Measure (FAAM) to measure change from Baseline at 4 time frames [ Time Frame: Baseline, 2wks, 4 wks, 12 wks, 6 months ]
    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

Secondary Outcome Measures :
  1. Global Rating of Change (GRC) to measure perceived change at 4 follow-up periods [ Time Frame: 2 wks, 4 wks, 12 weeks, 6 months ]
    The GRC is a 15 point scale used to measure patient's perceived change in their health status compared to baseline.

Other Outcome Measures:
  1. Numeric Pain Rating Scale (NPRS) to measure change from baseline at 4 different time frames [ Time Frame: Baseline, 2 wks, 4 wks, 12 wks and 6 months ]
    THe NPRS is a 11 point self report measure for rating the patient's pain. Will will be using the NPRS to rate first step pain.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01882894

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Contact: Robert E Boyles, PT, DSc 253-879-3633

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United States, Washington
University of Puget Sound
Tacoma, Washington, United States, 98416
Contact: Robert E Boyles, PT, DSc    253-879-3633   
Sponsors and Collaborators
University of Puget Sound
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Responsible Party: Robert Boyles, Clinical Associate Professor, University of Puget Sound Identifier: NCT01882894    
Other Study ID Numbers: PFO Trial
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013
Keywords provided by Robert Boyles, University of Puget Sound:
Plantar fasciitis, orthotic, functional outcome
Additional relevant MeSH terms:
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Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases