Plantar FasciitisNCT00650884
Plantar Fasciitis Treated With Dynamic Splinting
A study testing Ankle Dorsiflexion Dynasplint System in people with Plantar Fasciitis, run by Dynasplint Systems, Inc. at 4 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Ankle Dorsiflexion Dynasplint System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- Feb 2008to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lopez Foot Ankle Clinic
Fort Worth, Texas, 76164
Ankle & Foot Centers, PC
Marietta, Georgia, 30066
Orlando Foot & Ankle Center
Orlando, Florida
Kaiser Permanente
Sacramento, California, 95825
About this study
Official title: Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study
The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).
Read the 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.
- Conditions
- Plantar Fasciitis
- Being tested
- Ankle Dorsiflexion Dynasplint System
- Keywords
- Dynamic Splinting for low-load, prolonged-duration stretch
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle Dorsiflexion Dynasplint SystemDevice
Also called Cross-Over
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Ankle Dorsiflexion Dynasplint System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Foot Ankle Pain Disability Survey scores
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Dr Mathew M John, DPM, Study chair, Ankle & Foot Centers, PCBuck Willis, PhD, Study director, Dynasplint Systems, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650884
- Sponsor's protocol ID
- Dynasplint, DYN1-08-022
- Status last verified
- Apr 2012
- First submitted
- 31 Mar 2008
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16415278Riddle 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.
PubMed 12728038Riddle 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.
PubMed 15134610Dmitri 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.
PubMed 12160690Ross 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.
PubMed 12381799MacKay-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.
PubMed 2928396Willis 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
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.
PubMed 12756315Martin 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.
PubMed 11266478Ng 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.
PubMed 11266484Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. doi: 10.1016/s0950-3579(05)80228-6.
PubMed 8149440Intenzo 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.
PubMed 2054987Hepburn, G. Contracture and Stiff Joint Management with Dynasplint®. J Ortho Sports Phys Ther. 1987;8(10): 498-504
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Fasciopathy Treated With Dynamic Splinting: A Randomized, Controlled, Cross-Over Study
- ClinicalTrials.gov ID
- NCT00650884
- Acronym / sponsor ID
- Dynasplint, DYN1-08-022
- Conditions
- Plantar Fasciitis
- Keywords
- Dynamic Splinting for low-load, prolonged-duration stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | Device: Ankle Dorsiflexion Dynasplint SystemALL 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 | Device: Ankle Dorsiflexion Dynasplint SystemALL 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 | Device: Ankle Dorsiflexion Dynasplint SystemALL 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Achilles tendon injury
- Acute traumatic rupture of the plantar fascia
- Calcaneal bursitis
- Calcaneal neuritis
- Calcaneal stress fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle Dorsiflexion Dynasplint SystemAlso: Cross-OverDynamic 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. | Device | 1, 2, 3 |
Primary outcome
Change in Foot Ankle Pain Disability Survey scores
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
- Background: PubMed 16415278Guldemond 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.
- Background: PubMed 12728038Riddle 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.
- Background: PubMed 15134610Riddle 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.
- Background: PubMed 12160690Dmitri 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.
- Background: PubMed 12381799Ross 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.
- Background: PubMed 2928396MacKay-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.
- BackgroundWillis B, John M. Dynamic Splinting Increases Flexion for Hallux Rigidus. BioMechanics, 2007 Sept;14(9), pg49-53
- BackgroundWillis B. Post-TBI Gait Rehabilitation. Applied Neurol. 2007 Jul;3(7):25-26
- Background: PubMed 12756315Lemont 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.
- Background: PubMed 11266478Martin 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.
- Background: PubMed 11266484Ng 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.
- Background: PubMed 8149440Hart LE. Exercise and soft tissue injury. Baillieres Clin Rheumatol. 1994 Feb;8(1):137-48. doi: 10.1016/s0950-3579(05)80228-6.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Mathew M John, DPM study chair
Ankle & Foot Centers, PC
Buck Willis, PhD study director
Dynasplint Systems, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle Dorsiflexion Dynasplint System in people with Plantar Fasciitis, run by Dynasplint Systems, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Foot Ankle Pain Disability Survey scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00650884, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2012.