Plantar Fasciitis and the Use of Orthotics as Treatment

May 4, 2023 updated by: Talita Cumi Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: George Ampat, MBBS, MS, FRCS
  • Phone Number: 07871590593
  • Email: geampat@gmail.com

Study Contact Backup

Study Locations

  • United Kingdom
    • Merseyside
      • Southport, Merseyside, United Kingdom, PR8 3NS
        • Talita Cumi LTD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
Baseline, 3 weeks, 6 weeks, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 weeks, 6 weeks, 3 months and 6 months
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".
Baseline, 3 weeks, 6 weeks, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Talita Cumi Ltd.

Collaborators

Aetrex Worldwide Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2021

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

January 31, 2023

Study Registration Dates

First Submitted

May 14, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 20, 2021

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FFPETFETS002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing 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.

IPD Sharing Access Criteria

The non-identifiable data will be openly available as a supplementary document to the publication.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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