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
  Purpose

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


Condition Intervention
Plantar Fasciitis
Device: Ankle Dorsiflexion Dynasplint System

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study

Resource links provided by NLM:


Further study details as provided by Dynasplint Systems, Inc.:

Primary Outcome Measures:
  • Change in Foot Ankle Pain Disability Survey scores [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650884

Locations
United States, California
Kaiser Permanente
Sacramento, California, United States, 95825
United States, Florida
Orlando Foot & Ankle Center
Orlando, Florida, United States
United States, Georgia
Ankle & Foot Centers, PC
Marietta, Georgia, United States, 30066
United States, Texas
Lopez Foot Ankle Clinic
Ft Worth, Texas, United States, 76164
Sponsors and Collaborators
Dynasplint Systems, Inc.
Investigators
Study Chair: Dr Mathew M John, DPM Ankle & Foot Centers, PC
Study Director: Buck Willis, PhD Dynasplint Systems, Inc.
  More Information

Additional Information:
Publications:
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53
Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26
Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504

Responsible Party: Buck Willis, PhD: Clinical Research Director, Dynasplint Systems, Inc.
ClinicalTrials.gov Identifier: NCT00650884     History of Changes
Other Study ID Numbers: Dynasplint, DYN1-08-022
Study First Received: March 31, 2008
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Dynasplint Systems, Inc.:
Dynamic Splinting for low-load, prolonged-duration stretch

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases

ClinicalTrials.gov processed this record on July 29, 2014