Skip to main content
OpenTrials
Completed

NCT Number: NCT00650884

Plantar Fasciitis Treated With Dynamic Splinting

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente, Sacramento, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ankle Dorsiflexion Dynasplint System

Device

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.

Other names: Cross-Over

Primary outcomes

  1. Change in Foot Ankle Pain Disability Survey scores

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Dynasplint Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 2, 2008
Registry last updated
Apr 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.