Plantar Fasciitis and the Use of Orthotics as Treatment
Condition: Plantar Fascitis
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      To investigate whether the use of prefabricated Orthotics in shoes, in combination with the
      use of indoor comfort sandals with built-in arch support, benefits the treatment of plantar
      fasciitis more than the sole use of prefabricated Orthotics in shoes alone.
    

Detailed description: 
      The usual symptom of plantar fasciitis is "first-step pain", though plantar heel pain in
      general can be broadly associated with plantar fasciitis. Although most of the cases resolve
      within 10 months, 10% develop chronic plantar fasciitis. The pathomechanics of the condition
      is assumed to be due to excessive tensile loading, exacerbated by abnormal biomechanics of
      the legs such as pes planus, leg length discrepancy, and tightness of calf muscles.

      Foot Orthotics are commonly used in the conservative treatment of plantar fasciitis. It is
      thought that foot Orthotics reduce the symptoms of plantar fasciitis by reducing strain in
      the fascia during standing and ambulation. A handful of randomized controlled trials have
      evaluated the effects of foot Orthotics from a patient's perspective. However, systematic
      reviews of these trials have concluded that the evidence for the effectiveness of foot
      Orthotics in the treatment of plantar fasciitis is poor and that further investigation is
      needed. In addition, the limitation of the success of using orthotics may be because
      Orthotics can only be used in conjunction with shoes. Many people may not wear shoes when at
      home, meaning the Orthotics are not being used during this time. The feet are therefore
      unsupported for a significant number of hours when weight-bearing (walking and standing)
      without shoes. This research, therefore, involves testing the addition of contoured comfort
      sandals with built-in arch support that can be worn while at home, as well as the Orthotics
      which will be worn during the day with shoes. Contemporaneous research on Orthotics is
      limited to only using Orthotics and there are no studies that use both the Orthotics and
      comfort sandal.

      This is a randomised control trial that will be conducted over a 6-month period, during which
      participants will be asked to provide data in the form of completed surveys at 5 points
      throughout the study period. The aim of the study is to investigate whether the use of
      prefabricated Orthotics in shoes, in combination with the use of indoor comfort sandals with
      built-in arch support, benefits the treatment of plantar fasciitis more than the sole use of
      prefabricated Orthotics in shoes alone.

      The study population will include 104 participants who will be randomised into a study and
      control group. Participants in the study group will be asked to insert the Orthotics into
      normal footwear and to use them wherever possible. Participants will also be instructed to
      use the comfort sandal with built-in arch support when not using shoes whilst at home.
      Participants in group B will only be asked to use the Orthotic inserted into daily footwear
      wherever suitable (i.e. when outside of the home). Participants from both groups will be
      asked to continue with normal activities throughout the study period.

      During the 6 month study period, all participants will be asked to complete and submit
      surveys at baseline, 3 weeks, 6 weeks, 3 months and 6 months from entry into the study.
    

Intervention name(s): Aetrex L420 Compete Orthotic; Aetrex indoor comfort sandal with built-in arch support
Intervention type(s): Device; Device
Intervention description(s): An orthotic insole to be inserted into shoes. Orthotic for low arches to flat feet with no forefoot pain, featuring a posted heel to control over-pronation and provide balance. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia.; An indoor comfort sandal with built-in arch support to be used at home. Provides extreme cushioning, shock absorption and durability. Arch support helps to stabilize and align feet and also helps to relieve common foot pain & plantar fasciitis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment