Clinical trial NCT04894383: Plantar Fasciitis and the Use of Orthotics as Treatment
Official title: A Study Into the Use of Prefabricated Orthotics in Shoes, in Combination With Using Indoor Comfort Sandals With built-in Arch Support vs. the Sole Use of Prefabricated Orthotics in Shoes Alone, for the Treatment of Plantar Fasciitis. A Randomised Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Lead sponsor: Talita Cumi Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Aetrex Worldwide Inc
First posted: 2021-05-20
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Have been experiencing symptoms of Plantar Fasciitis for at least 2 months. A diagnosis of plantar fasciitis will be made on the criteria that the pain is located on the medial aspect of the heel on palpation and the pain is worst the first thing in the morning.
* Aged 19-75 years old

Exclusion Criteria:

* Prior operations on the foot,
* Prior treatments apart from analgesia in the last 12 months e.g. corticosteroid injections,
* Congenital or acquired foot and ankle abnormalities which prevent the use of normal footwear.

Primary outcomes:
measure: Changes in Pain as assessed by a Visual Analogue Scale (VAS)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Secondary outcomes:
measure: Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
measure: Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale)
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Southport
country: United Kingdom
facility: Talita Cumi LTD.
state: Merseyside
Study officials:
affiliation: Talita Cumi Ltd.
name: George Ampat, MBBS, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
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