Plantar Fasciitis Treated With Dynamic Splinting

Study Overview
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Brief Summary
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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
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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.

Official Title
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Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: Ankle Dorsiflexion Dynasplint System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>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. | Device: Ankle Dorsiflexion Dynasplint System<br>* Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.<br>* Other names: Cross-Over;|
| Experimental: 2<br>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. | Device: Ankle Dorsiflexion Dynasplint System<br>* Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.<br>* Other names: Cross-Over;|
| Other: 3<br>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. | Device: Ankle Dorsiflexion Dynasplint System<br>* Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living.<br>* Other names: Cross-Over;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Foot Ankle Pain Disability Survey scores |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dynamic Splinting for low-load, prolonged-duration stretch