Plantar Fasciitis Treated With Dynamic Splinting

Dynasplint Systems.

Status: Completed

Conditions: Plantar Fasciitis

Treatments: Device: Ankle Dorsiflexion Dynasplint System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00650884

Dynasplint, DYN1-08-022

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 3 patient groups

1

No Intervention group

Description:

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.

Treatment:

Device: Ankle Dorsiflexion Dynasplint System

2

Experimental group

Description:

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.

Treatment:

Device: Ankle Dorsiflexion Dynasplint System

3

Other group

Description:

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.

Treatment:

Device: Ankle Dorsiflexion Dynasplint System