Plantar Fasciosis Treatment Using Coblation

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.

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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