A Trial of Custom Foot Orthoses for the Treatment of Plantar Heel Pain

Rosalind Franklin University of Medicine and Science

Status: Completed

Conditions: Plantar Fasciitis

Treatments: Device: orthoses

Study type: Interventional

Funder types: Other

Identifiers

NCT00765843

ORT 067

Details and patient eligibility

About

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.

Enrollment: 77 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

---

77 participants in 3 patient groups

custom foot orthoses

Active Comparator group

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.

Treatment:

Device: orthoses

pre-fabricated orthoses

Active Comparator group

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.

Treatment:

Device: orthoses

sham insoles

Sham Comparator group

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.

Treatment:

Device: orthoses