Treatment of Plantar Fasciitis With Xeomin
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 4

Summary: 
      The plantar fascia is an inelastic, broad band of tissue on the plantar or undersurface of
      the foot.

      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.

      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical
      treatment modalities. Surgical treatment of plantar fasciitis is indicated only if
      nonsurgical means fail.

      A newer method of treating plantar fasciitis before resorting to surgery is the use of
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Treatment of plantar fasciitis
      with Xeomin is important, as there are limited studies on the subject to date. The purpose of
      this study is to examine the long-term results of using Xeomin to treat plantar fasciitis in
      one physician's (J.A.) practice at Rothman Institute Orthopaedics through a
      placebo-controlled, randomized, double-blinded study.
    

Detailed description: 
      The plantar fascia is an inelastic, broad band of muscle on the plantar or undersurface of
      the foot. It runs from the plantar surface of the calcaneus or heel bone to the plantar
      surface of all 5 toes. The plantar fascia maintains the arch shape of the plantar foot. It
      also helps with shock absorption upon weight bearing activities such as walking and running.

      Plantar fasciitis is an inflammation of the plantar fascia that causes heel and foot pain.
      This inflammation is often caused by over activity, improper shoes, flat feet, or excessive
      weight on the feet.

      The current standard orthopaedic management of plantar fasciitis begins with nonsurgical
      treatment modalities. Such methods include daily stretching of the fascia, foot orthotics or
      inserts to provide arch support, night splinting, and shock-wave therapy. Surgical treatment
      of plantar fasciitis is indicated only if nonsurgical means fail. However, surgery does have
      risks, which include but are not limited to bleeding, infection, and nerve injury.

      A newer method of treating plantar fasciitis before resorting to surgery is the use of
      Botulinum Toxin or Xeomin (incobotulinum toxin A, Merz USA). Xeomin can only be delivered via
      direct injection into the targeted muscle. It takes effect in 2 to 3 days and generally lasts
      up to 3 to 6 months. Some doctors give Xeomin injections every 3 months or longer for
      treating spastic muscles. However, others provide single injections to help achieve a
      specific goal.

      Treatment of plantar fasciitis with Xeomin is important, as there are limited studies on the
      subject to date. Much of the existing research involves BoTox A and non-controlled studies
      with less than 1 year of patient follow-up. To date, there is only 1 placebo-controlled,
      randomized, double-blinded study regarding BoTox A to treat plantar fasciitis. However, this
      study limits its follow-up to 8 weeks. The purpose of this study is to examine the long-term
      results of using Xeomin to treat plantar fasciitis in one physician's (J.A.) practice at
      Rothman Institute Orthopaedics through a placebo-controlled, randomized, double-blinded
      study.
    

Intervention name(s): Xeomin
Intervention type(s): Drug
Intervention description(s): Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: plantar fascia; plantar fascitis; botulinum toxin; Xeomin