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Plantar Fasciitis and the Use of Orthotics as Treatment

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ClinicalTrials.gov Identifier: NCT04894383
Recruitment Status : Recruiting
First Posted : May 20, 2021
Last Update Posted : October 21, 2022
Sponsor:
Collaborator:
Aetrex Worldwide Inc
Information provided by (Responsible Party):
Talita Cumi Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Plantar Fascitis Device: Aetrex L420 Compete Orthotic Device: Aetrex indoor comfort sandal with built-in arch support Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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
Actual Study Start Date : July 23, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.

Device: 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.
Active Comparator: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Pain as assessed by a Visual Analogue Scale (VAS) [ Time Frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months ]
    Pain will be collected on via a self-report Visual Analogue Scale (VAS) as follows: 0 to 10 where 0 is 'No Pain' and 10 is 'The worst imaginable pain'.


Secondary Outcome Measures :
  1. Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ) [ Time Frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months ]
    Foot Pain & Functionality scores will be collected using the FHSQ or Foot Health Status Questionnaire. The Foot Health Status Questionnaire is designed to assess foot pain, foot health and its relation to quality of life. The questionnaire has four domains consisting of 13 key items. The four domains are; foot pain, foot function, footwear and general foot health. The current study will only use the 2 subsections of Foot Pain and Foot Function. In these subsections, participants will be required to rate foot pain in the last week from 1 (none) to 5 (severe), how often the participant experienced different types of foot pain during the last week from 1 (never) to 5 (always), how much the participants feet interfered with everyday activities in the last week from 1 (not at all) to 5 (extremely) and overall foot health from 1 (excellent) to 5 (poor). Previous research has found the FHSQ to exhibit a strong degree of context, criterion and construct validity with high retest reliability.

  2. Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale) [ Time Frame: Baseline, 3 weeks, 6 weeks, 3 months and 6 months ]
    The Global Rating Scale of Change, or the GROC scale, will be used in the current study to assess participants overall health. This will give further insight into the effectiveness of the interventions. It is an 11 point scale from -5 to + 5. "-5" denotes "very much worse", "0" denotes "unchanged" and "+5" denotes "completely recovered".


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04894383


Contacts
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Contact: George Ampat, MBBS, MS, FRCS 07871590593 geampat@gmail.com
Contact: Jonathan Sims, BSc 01704808703 research@ampat.co.uk

Locations
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United Kingdom
Talita Cumi LTD. Recruiting
Southport, Merseyside, United Kingdom, PR8 3NS
Contact: George Ampat, MBBS, MS, FRCS    07871 590593    geampat@gmail.com   
Contact: Jonathan M Sims, BSc    01704808703    research@ampat.co.uk   
Principal Investigator: George Ampat, MBBS, MS, FRCS         
Sub-Investigator: Jonathan Sims, BSc         
Sub-Investigator: Jaida Madathikethu         
Sub-Investigator: Portia Amoako-Tawaiah         
Sponsors and Collaborators
Talita Cumi Ltd.
Aetrex Worldwide Inc
Investigators
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Principal Investigator: George Ampat, MBBS, MS, FRCS Talita Cumi Ltd.
More Information
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Publications of Results:

Other Publications:
Bennett PJ, Patterson C. The foot health status questionnaire (FHSQ): a new instrument for measuring outcomes of foot care. Australasian J Podiatr Med. 1998;32:55-9.

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Responsible Party: Talita Cumi Ltd.
ClinicalTrials.gov Identifier: NCT04894383    
Other Study ID Numbers: FFPETFETS002
First Posted: May 20, 2021    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: At the end of the study, data will be fully anonymised. Only non-identifiable, anonymised data will be archived along with the publication for use of other researchers. For instance, the age, sex, and study results of participants will be archived indefinitely as a supplementary document to the publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: The data will become available at the completion of the study on 31/12/2022. It will be available for other researchers indefinitely.
Access Criteria: The non-identifiable data will be openly available as a supplementary document to the publication.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases