Plantar Fasciitis and the Use of Orthotics as Treatment
NCT ID: NCT04894383
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2021-07-23
2023-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support
Participants from Group A will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en\_US) and an Aetrex comfort sandal with built-in arch support (https://www.aetrex.com/aetrex-flips-black-L3000M.html?lang=en\_US or https://www.aetrex.com/fiji-flips-women-watermelon-L7009W.html?lang=en\_US) according to participants shoe size. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the orthotic/comfort sandal wherever possible.
Aetrex L420 Compete Orthotic
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.
Aetrex indoor comfort sandal with built-in arch support
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.
Prefabricated Orthotics in shoes only
Group B will receive an L400 Compete Orthotic (https://www.aetrex.com/search?q=l420\&search-button=\&lang=en\_US) alone. The investigators will send an instruction sheet along with the Orthotic in the post, explaining how to use it. Alternatively, an online video tutorial on how to use the Orthotic will also be available throughout the study. The group will be asked to continue with usual activities, using the Orthotic wherever possible.
Aetrex L420 Compete Orthotic
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.
Interventions
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Aetrex L420 Compete Orthotic
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.
Aetrex indoor comfort sandal with built-in arch support
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.
Eligibility Criteria
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Inclusion Criteria
* Aged 19-75 years old
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
Yes
Sponsors
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Aetrex Worldwide Inc
INDUSTRY
Talita Cumi Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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George Ampat, MBBS, MS, FRCS
Role: PRINCIPAL_INVESTIGATOR
Talita Cumi Ltd.
Locations
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Talita Cumi LTD.
Southport, Merseyside, United Kingdom
Countries
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References
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Pfeffer G, Bacchetti P, Deland J, Lewis A, Anderson R, Davis W, Alvarez R, Brodsky J, Cooper P, Frey C, Herrick R, Myerson M, Sammarco J, Janecki C, Ross S, Bowman M, Smith R. Comparison of custom and prefabricated orthoses in the initial treatment of proximal plantar fasciitis. Foot Ankle Int. 1999 Apr;20(4):214-21. doi: 10.1177/107110079902000402.
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Other Identifiers
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FFPETFETS002
Identifier Type: -
Identifier Source: org_study_id
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