Plantar FasciitisPhase 4NCT00189592
Plantar Fasciosis Treatment Using Coblation
A Phase 4 study testing ArthroCare TOPAZ™ MicroDebrider™ using Coblation and Surgical Fasciotomy in people with Plantar Fasciitis, run by ArthroCare Corporation at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use. Read more about this study
- Who is it for?
- Ages 18 to 72 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- ArthroCare TOPAZ™ MicroDebrider™ using Coblation and Surgical Fasciotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Jun 2008
- 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 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of plantar fasciitis/fasciosis by all of the following:
- Tenderness with palpation and local pressure over the medial calcaneal tuberosity on passive dorsiflexion of the foot
- VAS (Visual Analog Scale) pain score of > 5 points on a scale of 0 to 10, during the first few minutes of walking in the morning
- Ultrasound or magnetic resonance imaging (MRI) confirming plantar fasciitis/fasciosis
- Symptoms consistent with plantar fasciitis/fasciosis for at least 6 months as assessed by patient history
- Pain unresponsive to non-steroidal anti-inflammatory drugs (NSAIDs) and any four of the following conservative treatments: rest, taping, orthotics, shoe modifications, night splinting, casting, physical therapy, or local corticosteroid injections for up to 3 months
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- Must be at least 18 years old and no more than 72 years old
- Must sign the Institutional Review Board (IRB) approved informed consent form
- Subject is willing and able to complete required follow-up
Who cannot join
- Body mass index (BMI) > 40
- History or documentation showing type I and type II diabetes mellitus
- Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
- History or documentation showing peripheral vascular disease or autoimmune disease
- Subject has received NSAIDs (e.g., ibuprofen, naproxen) for treatment of plantar fasciitis/fasciosis 2 weeks prior to treatment by this study
- Subject has received NSAIDs (e.g. ibuprofen, naproxen) or oral corticosteroids 2 weeks prior to treatment by this study
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- Subject is receiving worker's compensation
- Subject is currently involved in litigation related to the injury being studied
- Prior surgical treatment of the plantar fascia(s) to be treated by this study
- Subject is currently participating in another drug/device study related to the injured plantar fascia
- Pregnant or pregnant suspected subjects
- Clinically significant bilateral plantar fasciitis/fasciosis with a VAS pain scale of > 5 bilaterally
- Subject is not capable of understanding or responding to study questionnaires.
- Extracorporeal shockwave therapy (ESWT) within 6 months of study treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Weil Foot & Ankle Institute
Des Plaines, Illinois, 60016
About this study
Official title: Plantar Fasciosis Treatment Using Coblation® Prospective, Double-Blind, Randomized Controlled Study
The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use.
Read the detailed description
Severe recalcitrant heel pain, resulting from repetitive trauma to the plantar fascia, is a relatively commonly observed phenomenon. Although this condition is frequently referred to as 'heel spurs', plantar fasciitis (acute inflammatory stage) and plantar fasciosis (chronic degeneration) are currently accepted as the more accurate terms. Symptoms most often occur during the first few steps in the morning but may also be effected during intense activity or with prolonged standing. The source of pain symptoms, which are usually perceived as a gradual onset of burning, is located at the origin of the plantar fascia at the calcaneous (heel bone). Risk factors such as low or high arches or over-pronation of the foot, systemic disease, or obesity may exacerbate pain.
More than two million Americans receive treatment each year for plantar fasciitis and fasciosis. Conservative treatment options for plantar fasciosis include rest, stretching, strengthening, and massage, progressing to non-steroidal anti-inflammatories, steroid injections or iontophoresis with continued recalcitrance. Orthotics, heel cups, night splints and plantar strapping are other conservative options frequently recommended by treating physicians. Patient outcomes and response to conservative measures are usually positive, with non-responsive cases, approximately 10% of all presenting cases, receiving surgical care. Extracorporeal shockwave treatment has recently been advocated for the recalcitrant cases and has shown to be effective in 60-80 percent of the cases. Plantar fascia release, either partial or complete, is commonly the surgical procedure of choice for treating plantar fasciosis. However, this surgery has a risk of complications and is thought to alter the biomechanics of the foot, which may be linked to post-operative lateral column pain and long-term disability. Because of the potential postoperative sequelae with plantar fascia release, it is valuable to examine less invasive surgical techniques for treating recalcitrant plantar fasciosis.
The concept of using a plasma RF-based microsurgical approach as a viable modality for treating tendinosis, and now, recalcitrant plantar fasciosis, was originally drawn from the research work conducted in patients treated for congestive heart failure using laser or RF-based transmyocardial revascularization (TMR). The mechanism of action behind the clinical success observed with laser and RF-based TMR was theorized to be associated with the localized angiogenic healing response noted to occur following the procedure. Localized angiogenesis had not been observed previously using mechanical devices for TMR, which were also less successful clinically. To substantiate adopting a TMR-like approach for treating tendinosis, the capability of plasma RF-based microsurgery for initiating an angiogenic healing response was examined in vivo using histology and biochemical analysis. The sum of several studies provides good evidence to suggest that plasma RF-based microsurgery can promote an angiogenic healing response using an appropriate application.
Preliminary clinical experience following plasma RF-based micro-tenotomy has demonstrated excellent success in treating chronic, refractive tendinosis. The investigators reported that this technique was technically simple to perform and was much less invasive than conventional surgery. Patients had a rapid and uncomplicated recovery and reported minimal to no pain 7-10 days following the procedure; their pain relief persisted or improved through 24 months. Magnetic resonance imaging correlated well with clinical results. These promising clinical findings, as well as the evidence from the basic research studies, led us to consider evaluating this plasma RF-based approach for treating symptomatic, chronic, recalcitrant heel pain resembling plantar fasciosis. The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recalcitrant plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use, such as reduced incidence of postoperative complications and improved function, compared to conventional surgery.
- Conditions
- Plantar Fasciitis
- Being tested
- ArthroCare TOPAZ™ MicroDebrider™ using Coblation, Surgical Fasciotomy
- Keywords
- plantar fascia, plantar fasciitis, Coblation, fasciotomy, conventional surgical fasciotomy, heel spur, heel pain, aponeurosis, plasma based radiofrequency, angiogenesis
- Medical subject headings
- Fasciitis, Plantar, Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArthroCare TOPAZ™ MicroDebrider™ using CoblationDevice
Percutaneous treatment of plantar fascia using the Topaz device. No incision performed.
Surgical FasciotomyProcedure or surgery
Standard surgical fasciotomy using an incision to treat the plantar fascia.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Percutaneous Fasciotomy Receives: Device: ArthroCare TOPAZ™ MicroDebrider™ using Coblation |
| 2 | Active comparator | Standard Fasciotomy Receives: Procedure: Surgical Fasciotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Measured: at 24 hours, 48 hours, 7 to 14 days, 4 to 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes (3)
Compare the number of postoperative complications
Measured: When and if they occur
Evaluate changes in biomechanical function using Ankle-Hindfoot and Midfoot Scale
Measured: 4 to 6 weeks, 3 months, 6 months and 1 year
Assess function and quality of life by the sf-36 questionnaire
Measured: at 4 to 6 weeks, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- ArthroCare Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lowell S. Weil, Sr., DPM, Principal investigator, Weil Foot & Ankle Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00189592
- Sponsor's protocol ID
- A0105WW
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2005
- Last updated
- 26 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Fasciosis Treatment Using Coblation® Prospective, Double-Blind, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00189592
- Acronym / sponsor ID
- A0105WW
- Conditions
- Plantar Fasciitis
- Keywords
- plantar fascia, plantar fasciitis, Coblation, fasciotomy, conventional surgical fasciotomy, heel spur, heel pain, aponeurosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- ArthroCare CorporationUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 19 Sep 2005 (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 evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recurring plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use.
Detailed description
Severe recalcitrant heel pain, resulting from repetitive trauma to the plantar fascia, is a relatively commonly observed phenomenon. Although this condition is frequently referred to as 'heel spurs', plantar fasciitis (acute inflammatory stage) and plantar fasciosis (chronic degeneration) are currently accepted as the more accurate terms. Symptoms most often occur during the first few steps in the morning but may also be effected during intense activity or with prolonged standing. The source of pain symptoms, which are usually perceived as a gradual onset of burning, is located at the origin of the plantar fascia at the calcaneous (heel bone). Risk factors such as low or high arches or over-pronation of the foot, systemic disease, or obesity may exacerbate pain.
More than two million Americans receive treatment each year for plantar fasciitis and fasciosis. Conservative treatment options for plantar fasciosis include rest, stretching, strengthening, and massage, progressing to non-steroidal anti-inflammatories, steroid injections or iontophoresis with continued recalcitrance. Orthotics, heel cups, night splints and plantar strapping are other conservative options frequently recommended by treating physicians. Patient outcomes and response to conservative measures are usually positive, with non-responsive cases, approximately 10% of all presenting cases, receiving surgical care. Extracorporeal shockwave treatment has recently been advocated for the recalcitrant cases and has shown to be effective in 60-80 percent of the cases. Plantar fascia release, either partial or complete, is commonly the surgical procedure of choice for treating plantar fasciosis. However, this surgery has a risk of complications and is thought to alter the biomechanics of the foot, which may be linked to post-operative lateral column pain and long-term disability. Because of the potential postoperative sequelae with plantar fascia release, it is valuable to examine less invasive surgical techniques for treating recalcitrant plantar fasciosis.
The concept of using a plasma RF-based microsurgical approach as a viable modality for treating tendinosis, and now, recalcitrant plantar fasciosis, was originally drawn from the research work conducted in patients treated for congestive heart failure using laser or RF-based transmyocardial revascularization (TMR). The mechanism of action behind the clinical success observed with laser and RF-based TMR was theorized to be associated with the localized angiogenic healing response noted to occur following the procedure. Localized angiogenesis had not been observed previously using mechanical devices for TMR, which were also less successful clinically. To substantiate adopting a TMR-like approach for treating tendinosis, the capability of plasma RF-based microsurgery for initiating an angiogenic healing response was examined in vivo using histology and biochemical analysis. The sum of several studies provides good evidence to suggest that plasma RF-based microsurgery can promote an angiogenic healing response using an appropriate application.
Preliminary clinical experience following plasma RF-based micro-tenotomy has demonstrated excellent success in treating chronic, refractive tendinosis. The investigators reported that this technique was technically simple to perform and was much less invasive than conventional surgery. Patients had a rapid and uncomplicated recovery and reported minimal to no pain 7-10 days following the procedure; their pain relief persisted or improved through 24 months. Magnetic resonance imaging correlated well with clinical results. These promising clinical findings, as well as the evidence from the basic research studies, led us to consider evaluating this plasma RF-based approach for treating symptomatic, chronic, recalcitrant heel pain resembling plantar fasciosis. The purpose of this study is to evaluate the effectiveness of Coblation-based fasciotomy for relieving pain associated with recalcitrant plantar fasciosis and, secondarily, to determine whether there may be additional potential benefits stemming from its use, such as reduced incidence of postoperative complications and improved function, compared to conventional surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: ArthroCare TOPAZ™ MicroDebrider™ using CoblationPercutaneous Fasciotomy |
| 2 | Active comparator | Procedure: Surgical FasciotomyStandard Fasciotomy |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of plantar fasciitis/fasciosis by all of the following:
- Must be at least 18 years old and no more than 72 years old
- Must sign the Institutional Review Board (IRB) approved informed consent form
- Subject is willing and able to complete required follow-up
Key exclusion criteria (14 listed)
- Body mass index (BMI) > 40
- History or documentation showing type I and type II diabetes mellitus
- Physical findings and documentation of coagulopathy, infection, tumor or other systemic disease(s)
- History or documentation showing peripheral vascular disease or autoimmune disease
- Subject has received NSAIDs (e.g., ibuprofen, naproxen) for treatment of plantar fasciitis/fasciosis 2 weeks prior to treatment by this study
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 |
|---|---|---|
| ArthroCare TOPAZ™ MicroDebrider™ using CoblationPercutaneous treatment of plantar fascia using the Topaz device. No incision performed. | Device | A |
| Surgical FasciotomyStandard surgical fasciotomy using an incision to treat the plantar fascia. | Procedure or surgery | 2 |
Primary outcome
Pain relief
Time frame: at 24 hours, 48 hours, 7 to 14 days, 4 to 6 weeks, 3 months, 6 months, 12 months
3 secondary outcomes
Compare the number of postoperative complications
Time frame: When and if they occur
Evaluate changes in biomechanical function using Ankle-Hindfoot and Midfoot Scale
Time frame: 4 to 6 weeks, 3 months, 6 months and 1 year
Assess function and quality of life by the sf-36 questionnaire
Time frame: at 4 to 6 weeks, 3 months, 6 months, 1 year
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 26 Aug 2015.
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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.
Lowell S. Weil, Sr., DPM principal investigator
Weil Foot & Ankle Institute
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 ArthroCare TOPAZ™ MicroDebrider™ using Coblation and Surgical Fasciotomy in people with Plantar Fasciitis, run by ArthroCare Corporation 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 9 inclusion and 14 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 26 Aug 2015. 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 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?
Pain relief (time frame: at 24 hours, 48 hours, 7 to 14 days, 4 to 6 weeks, 3 months, 6 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2015.