Plantar Fasciitis Treated With Dynamic Splinting

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650884
• Other study ID #: Dynasplint, DYN1-08-022
• Status: Completed
• Phase: N/A
• First received: March 31, 2008
• Last updated: April 27, 2012
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: April 2012
• Source: Dynasplint Systems, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.

Locations

Country	Name	City	State
United States	Lopez Foot Ankle Clinic	Ft Worth	Texas
United States	Ankle & Foot Centers, PC	Marietta	Georgia
United States	Orlando Foot & Ankle Center	Orlando	Florida
United States	Kaiser Permanente	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
Dynasplint Systems, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (14)

Dmitri Luke BS. Plantar fasciitis: a new experimental approach to treatment. Med Hypotheses. 2002 Jul;59(1):95-7. Review. — View Citation

Guldemond NA, Leffers P, Sanders AP, Emmen H, Schaper NC, Walenkamp GH. Casting methods and plantar pressure: effects of custom-made foot orthoses on dynamic plantar pressure distribution. J Am Podiatr Med Assoc. 2006 Jan-Feb;96(1):9-18. — View Citation

Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. Review. — View Citation

Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504

Intenzo CM, Wapner KL, Park CH, Kim SM. Evaluation of plantar fasciitis by three-phase bone scintigraphy. Clin Nucl Med. 1991 May;16(5):325-8. — View Citation

Lemont H, Ammirati KM, Usen N. Plantar fasciitis: a degenerative process (fasciosis) without inflammation. J Am Podiatr Med Assoc. 2003 May-Jun;93(3):234-7. — View Citation

MacKay-Lyons M. Low-load, prolonged stretch in treatment of elbow flexion contractures secondary to head trauma: a case report. Phys Ther. 1989 Apr;69(4):292-6. — View Citation

Martin JE, Hosch JC, Goforth WP, Murff RT, Lynch DM, Odom RD. Mechanical treatment of plantar fasciitis. A prospective study. J Am Podiatr Med Assoc. 2001 Feb;91(2):55-62. — View Citation

Ng A, Beegle T, Rockett AK. Atypical presentation of plantar fasciitis secondary to soft-tissue mass infiltration. J Am Podiatr Med Assoc. 2001 Feb;91(2):89-92. — View Citation

Riddle DL, Pulisic M, Pidcoe P, Johnson RE. Risk factors for Plantar fasciitis: a matched case-control study. J Bone Joint Surg Am. 2003 May;85-A(5):872-7. Erratum in: J Bone Joint Surg Am. 2003 Jul;85-A(7):1338. — View Citation

Riddle DL, Schappert SM. Volume of ambulatory care visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004 May;25(5):303-10. — View Citation

Ross M. Use of the tissue stress model as a paradigm for developing an examination and management plan for a patient with plantar fasciitis. J Am Podiatr Med Assoc. 2002 Oct;92(9):499-506. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Foot Ankle Pain Disability Survey scores		12 weeks	No

External Links

•   Link