N/A
N=77
A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain
Plantar Fasciitis
Bottom Line
View on ClinicalTrials.gov: NCT00765843 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Heel Pain — 26.3; 27.9; 26.6; 23.9 score on a survey — p=0.78
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- orthoses (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rosalind Franklin University of Medicine and Science
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heel Pain |
26.3; 27.9; 26.6; 23.9; 22.3; 19.1 | 0.78 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00765843). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.