Plantar FasciitisPhase 4NCT01588730
Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
A Phase 4 study testing Ankle Dorsiflexion Dynasplint and Commercially Available Static Night splint in people with Plantar Fasciitis and Plantar Fasciopathy, run by Dynasplint Systems, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of 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, Plantar Fasciopathy
- What is being tested?
- Ankle Dorsiflexion Dynasplint and Commercially Available Static Night splint
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2015
- Phase
- Phase 4
- 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
- All patients will have had a history of at least 3 consecutive months of plantar heel pain well-localized to the plantar fascia.
- All patients will have failed an initial treatment of non-weight bearing plantar and Achilles stretching.
- Diagnosis will be confirmed by physical examination by a single physician (JPF) with a typical point of maximum tenderness over the medial tubercle of the calcaneus
Who cannot join
- rheumatoid arthritis
- local infection
- pregnancy
- patients with tumors
- unresolved fractures
- severe peripheral vascular disease
Show all 10Show fewer
- history of prior plantar fascia surgery
- history of plantar fascia rupture
- age <18 years
- recent ( within 6 weeks) steroid injection
Trial locations and contacts
1 site in 1 country.
United States1 site
SUN Orthopaedic Group Inc
Lewisburg, Pennsylvania, 17837
About this study
The purpose of this study is to compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).
- Conditions
- Plantar Fasciitis, Plantar Fasciopathy
- Being tested
- Ankle Dorsiflexion Dynasplint, Commercially Available Static Night splint
- Keywords
- PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy
- 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 DynasplintDevice
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
Commercially Available Static Night splintProcedure or surgery
A commericially avilable static night splint will be worn for 4-6 hours during rest.
| Study group | Role | What they receive |
|---|---|---|
| Dynasplint | Experimental | 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). Receives: Device: Ankle Dorsiflexion Dynasplint |
| Static Splint | Active comparator | The control group will be treated with a static splint for a minimum of 6 4 hours each night while sleeping with the end goal of 6-8 hours. Receives: Procedure: Commercially Available Static Night splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
FFI score
The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score
Measured: 16 weeks
Secondary outcomes (1)
Pain subscale and SROM questionnaire
Secondary outcome measures will include two month, four month, and twelve month overall heel pain reduction measured by the responses to the following questionnaires:
- Pain subscale of the validated Foot Function Index (PS-FFI)
- A patient-relevant outcome measures (SROM) questionnaire that included generic and condition -specific outcome measures related to pain, function, and satisfaction with the treatment outcome.
Measured: 2, 4 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2012 (estimated)
- Study startJun 2011
- Primary completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dynasplint Systems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Furia, MD, Principal investigator, SUN Orthopaedic Group Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01588730
- Sponsor's protocol ID
- Dyna-PF 2011
- Status last verified
- Aug 2013
- First submitted
- 14 Jul 2011
- Last updated
- 12 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Batt ME, Tanji JL, Skattum N. Plantar fasciitis: a prospective randomized clinical trial of the tension night splint. Clin J Sport Med. 1996 Jul;6(3):158-62.
PubMed 8792046Berlet GC, Anderson RB, Davis H, Kiebzak GM. A prospective trial of night splinting in the treatment of recalcitrant plantar fasciitis: the Ankle Dorsiflexion Dynasplint. Orthopedics. 2002 Nov;25(11):1273-5. doi: 10.3928/0147-7447-20021101-20.
PubMed 12452346Furia JP, Rompe JD .Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis and Achilles tendinopathy.Curr Opin Orthop 2007;18:102-111
Furia JP. The safety and efficacy of high energy extracorporeal shock wave therapy in active, moderately active, and sedentary patients with chronic plantar fasciitis. Orthopedics. 2005 Jul;28(7):685-92. doi: 10.3928/0147-7447-20050701-17.
PubMed 16119283Mizel MS, Marymont JV, Trepman E. Treatment of plantar fasciitis with a night splint and shoe modification consisting of a steel shank and anterior rocker bottom. Foot Ankle Int. 1996 Dec;17(12):732-5. doi: 10.1177/107110079601701203.
PubMed 8973894Powell M, Post WR, Keener J, Wearden S. Effective treatment of chronic plantar fasciitis with dorsiflexion night splints: a crossover prospective randomized outcome study. Foot Ankle Int. 1998 Jan;19(1):10-8. doi: 10.1177/107110079801900103.
PubMed 9462907Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. A prospective randomized study. Clin Orthop Relat Res. 1999 Nov;(368):190-5.
PubMed 10613168Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2514-22. doi: 10.2106/JBJS.I.01651.
PubMed 21048171Sheridan L, Lopez A, Perez A, John MM, Willis FB, Shanmugam R. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010 May-Jun;100(3):161-5. doi: 10.7547/1000161.
PubMed 20479445Wapner KL, Sharkey PF. The use of night splints for treatment of recalcitrant plantar fasciitis. Foot Ankle. 1991 Dec;12(3):135-7. doi: 10.1177/107110079101200301.
PubMed 1791004
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic and Static Splinting as a Treatment for Plantar Faciiopathy
- ClinicalTrials.gov ID
- NCT01588730
- Acronym / sponsor ID
- Dyna-PF 2011
- Conditions
- Plantar Fasciitis, Plantar Fasciopathy
- Keywords
- PF, Dynasplint, ADFD, AFD, Plantar Fasciitis, plantar Fasciopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Dynasplint Systems, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2015 (estimated)
- First posted
- 1 May 2012 (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 compare the Ankle Dorsiflexion Dynasplint System (DS) to static night splint for the reduction of pain from Plantar Fasciitis (Fasciopathy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynasplint | Experimental | Device: Ankle Dorsiflexion DynasplintDynamic 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). |
| Static Splint | Active comparator | Procedure: Commercially Available Static Night splintThe control group will be treated with a static splint for a minimum of 6 4 hours each night while sleeping with the end goal of 6-8 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients will have had a history of at least 3 consecutive months of plantar heel pain well-localized to the plantar fascia.
- All patients will have failed an initial treatment of non-weight bearing plantar and Achilles stretching.
- Diagnosis will be confirmed by physical examination by a single physician (JPF) with a typical point of maximum tenderness over the medial tubercle of the calcaneus
Key exclusion criteria (10 listed)
- rheumatoid arthritis
- local infection
- pregnancy
- patients with tumors
- unresolved fractures
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 DynasplintDynamic 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 | Dynasplint |
| Commercially Available Static Night splintA commericially avilable static night splint will be worn for 4-6 hours during rest. | Procedure or surgery | Static Splint |
Primary outcome
FFI score
Time frame: 16 weeks
The primary outcome measure will be difference between the pretreatment and two month cumulative Foot Function Index (PS-FFI) score
1 secondary outcome
Pain subscale and SROM questionnaire
Time frame: 2, 4 and 12 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Background: PubMed 8792046Batt ME, Tanji JL, Skattum N. Plantar fasciitis: a prospective randomized clinical trial of the tension night splint. Clin J Sport Med. 1996 Jul;6(3):158-62.
- Background: PubMed 12452346Berlet GC, Anderson RB, Davis H, Kiebzak GM. A prospective trial of night splinting in the treatment of recalcitrant plantar fasciitis: the Ankle Dorsiflexion Dynasplint. Orthopedics. 2002 Nov;25(11):1273-5. doi: 10.3928/0147-7447-20021101-20.
- BackgroundFuria JP, Rompe JD .Extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis and Achilles tendinopathy.Curr Opin Orthop 2007;18:102-111
- Background: PubMed 16119283Furia JP. The safety and efficacy of high energy extracorporeal shock wave therapy in active, moderately active, and sedentary patients with chronic plantar fasciitis. Orthopedics. 2005 Jul;28(7):685-92. doi: 10.3928/0147-7447-20050701-17.
- Background: PubMed 8973894Mizel MS, Marymont JV, Trepman E. Treatment of plantar fasciitis with a night splint and shoe modification consisting of a steel shank and anterior rocker bottom. Foot Ankle Int. 1996 Dec;17(12):732-5. doi: 10.1177/107110079601701203.
- Background: PubMed 9462907Powell M, Post WR, Keener J, Wearden S. Effective treatment of chronic plantar fasciitis with dorsiflexion night splints: a crossover prospective randomized outcome study. Foot Ankle Int. 1998 Jan;19(1):10-8. doi: 10.1177/107110079801900103.
- Background: PubMed 10613168Probe RA, Baca M, Adams R, Preece C. Night splint treatment for plantar fasciitis. A prospective randomized study. Clin Orthop Relat Res. 1999 Nov;(368):190-5.
- Background: PubMed 21048171Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am. 2010 Nov 3;92(15):2514-22. doi: 10.2106/JBJS.I.01651.
- Background: PubMed 20479445Sheridan L, Lopez A, Perez A, John MM, Willis FB, Shanmugam R. Plantar fasciopathy treated with dynamic splinting: a randomized controlled trial. J Am Podiatr Med Assoc. 2010 May-Jun;100(3):161-5. doi: 10.7547/1000161.
- Background: PubMed 1791004Wapner KL, Sharkey PF. The use of night splints for treatment of recalcitrant plantar fasciitis. Foot Ankle. 1991 Dec;12(3):135-7. doi: 10.1177/107110079101200301.
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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.
John Furia, MD principal investigator
SUN Orthopaedic Group Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ankle Dorsiflexion Dynasplint and Commercially Available Static Night splint in people with Plantar Fasciitis and Plantar Fasciopathy, run by Dynasplint Systems, Inc. at 1 site 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
FFI score (time frame: 16 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 NCT01588730, which also lists 10 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 12 Aug 2013.