Plantar Fasciitis Treated With Dynamic Splinting

Not Applicable

Completed

• Conditions: Plantar Fasciitis

• Registration Number: NCT00650884
• Lead Sponsor: Dynasplint Systems, Inc.

Brief Summary

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).

Detailed Description

To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-03-31
• Study First Submitted QC: 2008-03-31
• Study First Posted: 2008-04-02
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-27
• Last Update Posted: 2012-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:

• Pain on the bottom of the heel
• Pain that is usually worse upon arising or after long periods of non weight bearing
• Pain that increases over a period of months
• Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
• Morning mobility limitations
• Preference of patients to "walk on their toes"
• Paresthesias after non weight bearing (while sitting or lying down or both)
• Nocturnal pain
• Patients must be willing and able to sign the informed consent

Exclusion Criteria

• Achilles tendon injury
• Acute traumatic rupture of the plantar fascia
• Calcaneal bursitis
• Calcaneal neuritis
• Calcaneal stress fracture
• Lumbosacral radiculopathy of S1 nerve root
• Retrocalcaneal bursitis
• Tarsal tunnel syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Foot Ankle Pain Disability Survey scores	12 weeks

Trial Locations

Locations (4)

Kaiser Permanente; 🇺🇸 Sacramento, California, United States

Orlando Foot & Ankle Center; 🇺🇸 Orlando, Florida, United States

Ankle & Foot Centers, PC; 🇺🇸 Marietta, Georgia, United States

Lopez Foot Ankle Clinic; 🇺🇸 Ft Worth, Texas, United States