Plantar Fasciosis Treatment Using Coblation
Condition: Plantar Fasciitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): ArthroCare TOPAZ™ MicroDebrider™ using Coblation; Surgical Fasciotomy
Intervention type(s): Device; Procedure
Intervention description(s): Percutaneous treatment of plantar fascia using the Topaz device. No incision performed.; Standard surgical fasciotomy using an incision to treat the plantar fascia.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plantar fascia; plantar fasciitis; Coblation; fasciotomy; conventional surgical fasciotomy; heel spur; heel pain; aponeurosis; plasma based radiofrequency; angiogenesis