Back to resultsA Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Primary Purpose
Plantar Fasciitis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
orthoses
Sponsored by
About this trial
This is an interventional treatment trial for Plantar Fasciitis focused on measuring heel pain
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Sites / Locations
- Advocate Health Care
- Scholl Foot and Ankle Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Arm Label
custom foot orthoses
pre-fabricated orthoses
sham insoles
Arm Description
Subjects 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.
Subjects 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.
Subjects 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00765843
First Posted
October 2, 2008
Last Updated
June 19, 2014
Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Advocate Health Care
1. Study Identification
Unique Protocol Identification Number
NCT00765843
Brief Title
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Official Title
A Randomized Controlled Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rosalind Franklin University of Medicine and Science
Collaborators
Advocate Health Care
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
heel pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
custom foot orthoses
Arm Type
Active Comparator
Arm Description
Subjects 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.
Arm Title
pre-fabricated orthoses
Arm Type
Active Comparator
Arm Description
Subjects 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.
Arm Title
sham insoles
Arm Type
Sham Comparator
Arm Description
Subjects 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.
Intervention Type
Device
Intervention Name(s)
orthoses
Other Intervention Name(s)
shoe insert
Intervention Description
orthoses are provided for use in standardized shoes that all subjects receive
Primary Outcome Measure Information:
Title
Heel Pain
Description
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.
Time Frame
baseline, one month and three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Fleischer, DPM, MPH
Organizational Affiliation
Center for Lower Extremity Ambulatory Research (CLEAR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advocate Health Care
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60618
Country
United States
Facility Name
Scholl Foot and Ankle Center
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.CLEAR-Scholl.org
Description
Center for Lower Extremity Ambulatory Research
Learn more about this trial
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
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