Clinical Trial: Plantar Fasciosis Treatment Using Coblation

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Plantar Fasciosis Treatment Using Coblation® Prospective, Double-Blind, Randomized Controlled Study

Brief 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 Summary:

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 postoperat
Sponsor: ArthroCare Corporation

Current 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 ]

Original Primary Outcome:

  • Pain relief:
  • 24 hrs
  • 48 hrs
  • 14 to 20 days
  • 4 to 6 weeks
  • 3 months
  • 6 months
  • 12 months


Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • Compare the number of postoperative complications
  • Evaluate changes in biomechanical function using Ankle-Hindfoot and Midfoot Scale.
  • Assess function and quality of life by the sf-36 questionnaire
  • 4 to 6 weeks
  • 3 months
  • 6 months
  • 1 year


Information By: ArthroCare Corporation

Dates:
Date Received: September 12, 2005
Date Started: August 2005
Date Completion:
Last Updated: August 25, 2015
Last Verified: August 2015