Plantar Fasciitis Treated With Dynamic Splinting

NCT00650884 | Completed DMC

• 1 other identifier: Dynasplint, DYN1-08-022
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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).

Conditions

Plantar Fasciitis

Keywords

Dynamic Splinting for low-load, prolonged-duration stretch

Outcome Measures

Primary Outcomes (1)

• Change in Foot Ankle Pain Disability Survey scores

  12 weeks

Study Arms (3)

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.

Device: Ankle Dorsiflexion Dynasplint System

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.

Device: Ankle Dorsiflexion Dynasplint System

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.

Device: Ankle Dorsiflexion Dynasplint System

Interventions

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.

Also known as: Cross-Over

1; 2; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dynasplint Systems, Inc.: lead

Study Sites (4)

Kaiser Permanente

Sacramento, California, 95825, United States

Location

Orlando Foot & Ankle Center

Orlando, Florida, United States

Location

Ankle & Foot Centers, PC

Marietta, Georgia, 30066, United States

Location

Lopez Foot Ankle Clinic

Fort Worth, Texas, 76164, United States

Location

Related Publications (14)

• 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.

  PMID: 16415278 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.

  PMID: 12728038 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.

  PMID: 15134610 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.

  PMID: 12160690 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.

  PMID: 12381799 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.

  PMID: 2928396 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

  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.

  PMID: 12756315 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.

  PMID: 11266478 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.

  PMID: 11266484 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.

  PMID: 8149440 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.

  PMID: 2054987 BACKGROUND

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

  BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Cross-Over Studies

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Dr Mathew M John, DPM

  Ankle & Foot Centers, PC

  STUDY CHAIR

• Buck Willis, PhD

  Dynasplint Systems, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 2, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 30, 2012

Record last verified: 2012-04

Locations

US (4)