Plantar Fasciitis Treated With Dynamic Splinting

This study has been completed.
Sponsor:
Information provided by:
Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier:
NCT00650884
First received: March 31, 2008
Last updated: April 27, 2012
Last verified: April 2012

March 31, 2008
April 27, 2012
February 2008
January 2009   (final data collection date for primary outcome measure)
Change in Foot Ankle Pain Disability Survey scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00650884 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Plantar Fasciitis Treated With Dynamic Splinting
Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Plantar Fasciitis
Device: Ankle 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.
Other Name: Cross-Over
  • No Intervention: 1
    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.
    Intervention: Device: Ankle Dorsiflexion Dynasplint System
  • Experimental: 2
    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.
    Intervention: Device: Ankle Dorsiflexion Dynasplint System
  • 3
    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.
    Intervention: Device: Ankle Dorsiflexion Dynasplint System

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00650884
Dynasplint, DYN1-08-022
Yes
Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
Not Provided
Study Chair: Dr Mathew M John, DPM Ankle & Foot Centers, PC
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
Dynasplint Systems, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP