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Plantar Fasciitis and the Use of Orthotics as Treatment

Primary Purpose

Plantar Fascitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Aetrex L420 Compete Orthotic
Aetrex indoor comfort sandal with built-in arch support
Sponsored by
Talita Cumi Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Talita Cumi LTD.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support

Prefabricated Orthotics in shoes only

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in Pain as assessed by a Visual Analogue Scale (VAS)
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

Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)
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.
Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale)
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".

Full Information

First Posted
May 14, 2021
Last Updated
May 4, 2023
Sponsor
Talita Cumi Ltd.
Collaborators
Aetrex Worldwide Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04894383
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
November 11, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Talita Cumi Ltd.
Collaborators
Aetrex Worldwide Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prefabricated Orthotics in shoes & indoor comfort sandals with built-in arch support
Arm Type
Experimental
Arm Description
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.
Arm Title
Prefabricated Orthotics in shoes only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aetrex L420 Compete Orthotic
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Aetrex indoor comfort sandal with built-in arch support
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pain as assessed by a Visual Analogue Scale (VAS)
Description
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'.
Time Frame
Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)
Description
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.
Time Frame
Baseline, 3 weeks, 6 weeks, 3 months and 6 months
Title
Changes in overall health as assessed by The Global Rating Scale of Change (GROC scale)
Description
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".
Time Frame
Baseline, 3 weeks, 6 weeks, 3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Ampat, MBBS, MS, FRCS
Organizational Affiliation
Talita Cumi Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Talita Cumi LTD.
City
Southport
State/Province
Merseyside
ZIP/Postal Code
PR8 3NS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Plantar Fasciitis and the Use of Orthotics as Treatment

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