A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
1 other identifier
interventional
77
1 country
2
Brief Summary
This is a study investigating treatment of plantar fasciitis (heel pain). Physicians commonly prescribe specialized orthoses (shoe inserts) to treat heel pain. This study will evaluate the reduction in heel pain associated with three types of orthoses. It is hypothesized that custom made orthoses will significantly decrease pain and improve foot function in comparison to prefabricated insoles and sham insoles.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2008
Longer than P75 for not_applicable
2 active sites
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
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 2, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedJuly 21, 2014
June 1, 2014
3.9 years
October 2, 2008
April 28, 2014
June 19, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heel Pain
Overall foot pain as determined by the Foot Function Index-Revised (FFI-R) survey. Foot pain is assessed by answering 11 questions regarding foot pain experienced over the past week. Scores may range from 11 to 66. Higher scores are indicative of greater foot pain.
baseline, one month and three months
Study Arms (3)
custom foot orthoses
ACTIVE COMPARATORSubjects will receive custom fabricated orthoses created from casts of the feet and according to individualized prescriptions. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
pre-fabricated orthoses
ACTIVE COMPARATORSubjects will be provided pre-fabricated (non-customized) orthoses. These orthoses are to be used in the standardized shoes provided to all subjects in the study. for use in their shoes.
sham insoles
SHAM COMPARATORSubjects will receive sham orthoses that are soft and pliable, but not designed to relieve pain. These orthoses are to be used in the standardized shoes provided to all subjects in the study.
Interventions
orthoses are provided for use in standardized shoes that all subjects receive
Eligibility Criteria
You may qualify if:
- Patients will be included if they present for each of the following:
- Pain at plantar fascial attachment to calcaneal tubercle and/or pain distal from tubercle along plantar fascial band
- Typical post-static dyskinesia. Pain first steps in morning or when getting up after being seated for a period of time
- Patients will be ambulatory with an age range of 18-75 with plantar heel pain present for no more than one year.
- They will not have previous injection within 6 months or currently use prescription custom foot orthoses.
- Patient history, exam, x-rays, and ultrasound will rule out other etiologies of heel pain including proximal or local nerve entrapment, arthritis, bone cyst or tumor, or stress fracture. Since most patients will likely self-treat this condition prior to seeking care, the investigators will allow a washout period (appendix) and acetaminophen rescue analgesia provision.
You may not qualify if:
- Proximal musculoskeletal pathology (i.e., knee or hip arthritis, sciatica secondary to back pathology, significant limb length discrepancy.
- Use of gait assistive devices (crutches, canes, walkers).
- Inability to wear supportive closed toed shoes.
- Lack of range motion at the first metatarsophalangeal joint or subtalar joint.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Advocate Health Care
Chicago, Illinois, 60618, United States
Scholl Foot and Ankle Center
North Chicago, Illinois, 60064, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ryan Crews
- Organization
- Rosalind Franklin University of Medicine and Science
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Fleischer, DPM, MPH
Center for Lower Extremity Ambulatory Research (CLEAR)
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 2, 2008
First Posted
October 3, 2008
Study Start
October 1, 2008
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
July 21, 2014
Results First Posted
July 21, 2014
Record last verified: 2014-06