Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | No Intervention | 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. |
|
| 2 | Experimental | 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. |
|
| 3 | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Foot Ankle Pain Disability Survey scores | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dr Mathew M John, DPM | Ankle & Foot Centers, PC | Study Chair |
| Buck Willis, PhD | Dynasplint Systems, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Sacramento | California | 95825 | United States | ||
| Orlando Foot & Ankle Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16415278 | Background | 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. | |
| 12728038 | Background | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D018592 | Cross-Over Studies |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Orlando |
| Florida |
| United States |
| Ankle & Foot Centers, PC | Marietta | Georgia | 30066 | United States |
| Lopez Foot Ankle Clinic | Fort Worth | Texas | 76164 | United States |
| 15134610 | Background | 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. |
| 12160690 | Background | 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. |
| 12381799 | Background | 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. |
| 2928396 | Background | 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. |
| Background | Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53 |
| Background | Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26 |
| 12756315 | Background | 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. |
| 11266478 | Background | 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. |
| 11266484 | Background | 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. |
| 8149440 | Background | Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. doi: 10.1016/s0950-3579(05)80228-6. |
| 2054987 | Background | 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. |
| Background | Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |