Clinical trial NCT00650884: Plantar Fasciitis Treated With Dynamic Splinting
Official title: Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: Dynamic Splinting for low-load, prolonged-duration stretch
Lead sponsor: Dynasplint Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in Foot Ankle Pain Disability Survey scores
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Kaiser Permanente
state: California
city: Orlando
country: United States
facility: Orlando Foot & Ankle Center
state: Florida
city: Marietta
country: United States
facility: Ankle & Foot Centers, PC
state: Georgia
city: Ft Worth
country: United States
facility: Lopez Foot Ankle Clinic
state: Texas
Study officials:
affiliation: Ankle & Foot Centers, PC
name: Dr Mathew M John, DPM
role: STUDY_CHAIR
affiliation: Dynasplint Systems, Inc.
name: Buck Willis, PhD
role: STUDY_DIRECTOR
References:
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. doi: 10.7547/0960009.
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(5):872-7. doi: 10.2106/00004623-200305000-00015.
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. doi: 10.1177/107110070402500505.
citation: Dmitri Luke BS. Plantar fasciitis: a new experimental approach to treatment. Med Hypotheses. 2002 Jul;59(1):95-7. doi: 10.1016/s0306-9877(02)00120-2.
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. doi: 10.7547/87507315-92-9-499.
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. doi: 10.1093/ptj/69.4.292.
citation: Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53
citation: Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26
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. doi: 10.7547/87507315-93-3-234.
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. doi: 10.7547/87507315-91-2-55.
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. doi: 10.7547/87507315-91-2-89.
citation: Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. doi: 10.1016/s0950-3579(05)80228-6.
citation: 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. doi: 10.1097/00003072-199105000-00006.
citation: Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504