Comparing the Effects of Two Foot and Ankle Splints for Foot Pain

Study Overview
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Brief Summary
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Plantar fasciitis (severe pain in the heel) is a common problem that has a significant impact on quality of life. There is some evidence to support the use of orthoses and stretches in the conservative management of plantar fasciitis but current orthotic management may not be optimal. More prolonged stretching with night splints may achieve better results but such splints are clinically not well tolerated. Therefore, there is a potential need to apply prolonged stretching during the day and during dynamic tasks such as walking. This has led to the development of other rigid and semi-rigid splints that have shown promising results in small scale clinical trials. There are disadvantages however with the more rigid bracing and orthoses seen in these types of splints. For example, they are often difficult to accommodate with a person's available shoes; this can be particularly difficult for women and thus limits their compliance with the intervention. Further, more rigid bracing can be uncomfortable during fast walking and running and so limits participation in such activities. Recently a novel orthotic, a customised dynamic elastomeric fabric orthoses (DEFO), has been developed. Being made from lycra® based materials the sock-like splint is lightweight and discrete, allowing it to be accommodated easily into most shoe types and potentially better tolerated when worn at night compared to currently available splints. Its design further allows it to be used comfortably during dynamic tasks such as walking and running as supported by initial anecdotal evidence in athletes. To date there has been no evaluation into the effectiveness of the DEFO in the general population with plantar fasciitis. This study will look at the feasibility of conducting a randomised controlled trial into the use of a DEFO compared to an off-the-shelf orthoses as an adjunct to usual care.

Detailed Description
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Plantar fasciitis is the most common foot and ankle pathology that affects the general population. It affects over 1 million people in the USA equating to  0.2 million in the UK. It is characterized by severe pain felt on the plantar aspect of the heel around the plantar fascia origin which is significantly thicker than normal. Usually conservative treatment comprises a referral to physiotherapy and provision of orthotics. Physiotherapy consists of teaching a home program of calf and plantar fascia stretches in addition to weight management and footwear advice. Orthotic management includes the provision of off-the-shelf orthotics or customised orthotics. Some studies of customised orthoses demonstrate significant improvements in foot pain related function at 3 and 12 months in people with plantar fasciitis compared to a sham intervention. However, a systematic review of the randomised controlled trials found no evidence to support their use on short or long term foot pain, pain related function or disability. Dynamic elastomeric fabric orthoses (DEFOs) have been successfully used in a variety of patient groups. The plantar fasciitis DEFOs is a custom-made close-fitting sock of elastomeric construction. It is worn next to the skin where the sock can exert an external torsional, compressive, and supportive effect, thus positively influencing the biomechanics of the heal.

Official Title
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The Effectiveness of a Dynamic Elastomeric Fabric Orthoses (DEFO) in the Management of Plantar Fasciitis: A Feasibility Study

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Device: Dynamic elastomeric fabric orthoses (DEFO)
* Device: Off -the-shelf triplanar orthoses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 18 years old Plantar heel pain for greater than 3 months Exclusion Criteria: Calcaneal fracture Additional neurological or orthopaedic / rheumatological impairments

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynamic elastomeric fabric orthoses (DEFO)<br>The DEFO will be provided after taking the baseline measures and orthoses measurements at the baseline session   3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks. | Device: Dynamic elastomeric fabric orthoses (DEFO)<br>* A patient customised dynamic elastomeric fabric orthoses (DEFO)<br>* Other names: DEFO;|
| Active Comparator: Off-the-self orthotics<br>Off-the-shelf-Orthotics: Patients in the usual care group will be referred for off -the-shelf triplanar orthoses as indicated by a biomechanical assessment of foot posture while standing / walking on visit 1. The off the shelf orthotic will be provided after taking the baseline measures and orthoses measurements at the baseline session   3 weeks later. The orthoses will be supplied via post and used for a period of 12 weeks. | Device: Off -the-shelf triplanar orthoses<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot and Ankle Ability Measure (FAAM) | This is a patient reported questionnaire asking about the impact of the foot and ankle on 21 activities of daily living and 8-sport related activities. It has demonstrated validity for this client group (correlating with physical function subscales of the SF-36) and shows good test-retest reliability | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue scales | Visual analogue / Numerical rating scales are commonly used to measure pain in clinical trials, having demonstrated good validity, reliability and responsiveness. Patients will indicate (a) their current heel pain and (b) their worst pain over the last 48 hrs using a numerical rating scale. 0 will indicate no pain at all and 10 will indicate their worst imaginable pain and numbers from 0-10 will be shown. | Up to 12 weeks | 
| Ankle Range of Motion | The extensibility of the ankle plantarflexors will be determined by measuring the angle of the tibia to the vertical using an inclinometer during a lunge stretch. | Up to 12 weeks | 
| Plantar Fascia thickness | The thickness of the plantar fascia enthesis will be measured using ultrasound. | Up to 12 weeks | 
| Quality of Life (QoL) | This will be measured using both the Foot Health Status Questionnaire and the EQ-5D. The Foot Health Status Questionnaire measures foot health related quality of life and has demonstrated validity and reliability whilst the EQ-5D is recommended for health economic evaluations (and hence piloting of its use in this feasibility study is of value). | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciitis, dynamic elastomeric fabric orthoses (DEFO), feasibility, Physiotherapy, Musculoskeletal