Plantar Fasciitis and the Use of Orthotics as Treatment

NCT04894383 | Completed DMC

• 1 other identifier: FFPETFETS002
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (1)

• 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'.

  Baseline, 3 weeks, 6 weeks, 3 months and 6 months

Secondary Outcomes (2)

• Changes in Foot health status as assessed by the Foot Health Status Questionnaire (FHSQ)

  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)

  Baseline, 3 weeks, 6 weeks, 3 months and 6 months

Study Arms (2)

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

EXPERIMENTAL

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; Device: Aetrex indoor comfort sandal with built-in arch support

Prefabricated Orthotics in shoes only

ACTIVE COMPARATOR

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

Interventions

Aetrex L420 Compete Orthotic DEVICE

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.

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

Aetrex indoor comfort sandal with built-in arch support DEVICE

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 & indoor comfort sandals with built-in arch support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Talita Cumi Ltd.: lead
• Aetrex Worldwide Inc: collaborator

Study Sites (1)

Talita Cumi LTD.

Southport, Merseyside, PR8 3NS, United Kingdom

Location

Related Publications (26)

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• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.

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• Wearing SC, Smeathers JE, Urry SR, Hennig EM, Hills AP. The pathomechanics of plantar fasciitis. Sports Med. 2006;36(7):585-611. doi: 10.2165/00007256-200636070-00004.

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  PMID: 10609710 RESULT

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  PMID: 10229276 RESULT

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  PMID: 18646168 RESULT

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  PMID: 28328852 RESULT

• Riskowski JL, Hagedorn TJ, Hannan MT. Measures of foot function, foot health, and foot pain: American Academy of Orthopedic Surgeons Lower Limb Outcomes Assessment: Foot and Ankle Module (AAOS-FAM), Bristol Foot Score (BFS), Revised Foot Function Index (FFI-R), Foot Health Status Questionnaire (FHSQ), Manchester Foot Pain and Disability Index (MFPDI), Podiatric Health Questionnaire (PHQ), and Rowan Foot Pain Assessment (ROFPAQ). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S229-39. doi: 10.1002/acr.20554. No abstract available.

  PMID: 22588747 RESULT

• Lopez Lopez D, Lopez Martinez NZ, Losa Iglesias ME, Rodriguez Sanz D, Palomo Lopez P, Becerro de Bengoa Vallejo R. Impact on quality of life related to foot health in a sample of menopausal women: a case-control observational study. Climacteric. 2016 Oct;19(5):501-5. doi: 10.1080/13697137.2016.1198314. Epub 2016 Jun 24.

  PMID: 27338169 RESULT

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  PMID: 26816663 RESULT

• Grim C, Kramer R, Engelhardt M, John SM, Hotfiel T, Hoppe MW. Effectiveness of Manual Therapy, Customised Foot Orthoses and Combined Therapy in the Management of Plantar Fasciitis-a RCT. Sports (Basel). 2019 May 28;7(6):128. doi: 10.3390/sports7060128.

  PMID: 31141994 RESULT

• Rome K, Gray J, Stewart F, Hannant SC, Callaghan D, Hubble J. Evaluating the clinical effectiveness and cost-effectiveness of foot orthoses in the treatment of plantar heel pain: a feasibility study. J Am Podiatr Med Assoc. 2004 May-Jun;94(3):229-38. doi: 10.7547/0940229.

  PMID: 15153583 RESULT

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  PMID: 27835963 RESULT

Study Officials

• George Ampat, MBBS, MS, FRCS

  Talita Cumi Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 20, 2021
• Study Start: July 23, 2021
• Primary Completion: November 11, 2022
• Study Completion: January 31, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

GB (1)