Plantar Fasciitis Treated With Dynamic Splinting

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Device: Ankle Dorsiflexion Dynasplint System

• 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

Arm && Interventions

Group	Intervention	Description
1	Ankle Dorsiflexion Dynasplint System	ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CONTROL PATIENTS will only be treated with Standard of Care during this 12 week trial, but will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch after completion of this study.
2	Ankle Dorsiflexion Dynasplint System	ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). EXPERIMENTAL PATIENTS will also be treated with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.
3	Ankle Dorsiflexion Dynasplint System	ALL PATIENTS WILL BE TREATED WITH STANDARD OF CARE (Orthoses, NSAIDs, Home therapy instructions). CROSS-OVER patients will be initially treated only with Standard of Care, and after six weeks, they will be Crossed-Over and fit with the Ankle Dorsiflexion Dynasplint System which delivers a low-load, prolonged-duration stretch while sleeping.

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

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

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