Status:
COMPLETED
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Lead Sponsor:
Rosalind Franklin University of Medicine and Science
Collaborating Sponsors:
Wake Forest University Health Sciences
Conditions:
Plantar Fasciitis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00765843
Start Date
October 1 2008
End Date
September 1 2012
Last Update
July 21 2014
Active Locations (2)
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1
Advocate Health Care
Chicago, Illinois, United States, 60618
2
Scholl Foot and Ankle Center
North Chicago, Illinois, United States, 60064