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Plantar Fasciitis Treated With Dynamic Splinting

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle Dorsiflexion Dynasplint System
Sponsored by
Dynasplint Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis focused on measuring Dynamic Splinting for low-load, prolonged-duration stretch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente
  • Orlando Foot & Ankle Center
  • Ankle & Foot Centers, PC
  • Lopez Foot Ankle Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Other

Arm Label

1

2

3

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Foot Ankle Pain Disability Survey scores

Secondary Outcome Measures

Full Information

First Posted
March 31, 2008
Last Updated
April 27, 2012
Sponsor
Dynasplint Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00650884
Brief Title
Plantar Fasciitis Treated With Dynamic Splinting
Official Title
Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dynasplint Systems, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis
Keywords
Dynamic Splinting for low-load, prolonged-duration stretch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Ankle Dorsiflexion Dynasplint System
Other Intervention Name(s)
Cross-Over
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Foot Ankle Pain Disability Survey scores
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Mathew M John, DPM
Organizational Affiliation
Ankle & Foot Centers, PC
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Buck Willis, PhD
Organizational Affiliation
Dynasplint Systems, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaiser Permanente
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Orlando Foot & Ankle Center
City
Orlando
State/Province
Florida
Country
United States
Facility Name
Ankle & Foot Centers, PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Lopez Foot Ankle Clinic
City
Ft Worth
State/Province
Texas
ZIP/Postal Code
76164
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16415278
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.
Results Reference
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PubMed Identifier
12728038
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. Erratum In: J Bone Joint Surg Am. 2003 Jul;85-A(7):1338.
Results Reference
background
PubMed Identifier
15134610
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.
Results Reference
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PubMed Identifier
12160690
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.
Results Reference
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PubMed Identifier
12381799
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.
Results Reference
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PubMed Identifier
2928396
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.
Results Reference
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Citation
Willis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53
Results Reference
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Citation
Willis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26
Results Reference
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PubMed Identifier
12756315
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.
Results Reference
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PubMed Identifier
11266478
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.
Results Reference
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PubMed Identifier
11266484
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.
Results Reference
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PubMed Identifier
8149440
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.
Results Reference
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PubMed Identifier
2054987
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.
Results Reference
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Citation
Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504
Results Reference
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Links:
URL
http://www.dynasplint.com
Description
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Plantar Fasciitis Treated With Dynamic Splinting

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