Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2013 by University of Puget Sound.
Recruitment status was  Not yet recruiting
Information provided by (Responsible Party):
Robert Boyles, University of Puget Sound
ClinicalTrials.gov Identifier:
First received: June 17, 2013
Last updated: June 20, 2013
Last verified: June 2013
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 Intervention
Plantar Fasciitis
Device: Custom PFO
Other: Faux orthosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of a Custom Temporary Foot Orthosis for Plantar Fasciitis Treatment: A Randomized Controlled Trial.

Resource links provided by NLM:

Further study details as provided by University of Puget Sound:

Primary Outcome Measures:
  • Foot Ankle Ability Measure (FAAM) to measure change from Baseline at 4 time frames [ Time Frame: Baseline, 2wks, 4 wks, 12 wks, 6 months ] [ Designated as safety issue: No ]
    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:
  • Global Rating of Change (GRC) to measure perceived change at 4 follow-up periods [ Time Frame: 2 wks, 4 wks, 12 weeks, 6 months ] [ Designated as safety issue: No ]
    The GRC is a 15 point scale used to measure patient's perceived change in their health status compared to baseline.

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01882894

Contact: Robert E Boyles, PT, DSc 253-879-3633 bboyles@pugetsound.edu

United States, Washington
University of Puget Sound Not yet recruiting
Tacoma, Washington, United States, 98416
Contact: Robert E Boyles, PT, DSc    253-879-3633    bboyles@pugetsound.edu   
Sponsors and Collaborators
University of Puget Sound
  More Information

No publications provided

Responsible Party: Robert Boyles, Clinical Associate Professor, University of Puget Sound
ClinicalTrials.gov Identifier: NCT01882894     History of Changes
Other Study ID Numbers: PFO Trial 
Study First Received: June 17, 2013
Last Updated: June 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Puget Sound:
Plantar fasciitis, orthotic, functional outcome

Additional relevant MeSH terms:
Fasciitis, Plantar
Foot Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 08, 2016