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Plantar Fasciitis Treated With Dynamic Splinting

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00650884
Enrollment
66
Registered
2008-04-02
Start date
2008-02-29
Completion date
2009-01-31
Last updated
2012-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis

Keywords

Dynamic Splinting for low-load, prolonged-duration stretch

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.

Interventions

DEVICEAnkle Dorsiflexion Dynasplint System

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.

Sponsors

Dynasplint Systems, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in Foot Ankle Pain Disability Survey scores12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026