Clinical trial NCT02212444: Comparing the Effects of Two Foot and Ankle Splints for Foot Pain
Official title: The Effectiveness of a Dynamic Elastomeric Fabric Orthoses (DEFO) in the Management of Plantar Fasciitis: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis
dynamic elastomeric fabric orthoses (DEFO)
feasibility
Physiotherapy
Musculoskeletal
Lead sponsor: University Hospital Plymouth NHS Trust
Sponsor class: OTHER
First posted: 2014-08-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years old
* Plantar heel pain for greater than 3 months

Exclusion Criteria:

* Calcaneal fracture
* Additional neurological or orthopaedic / rheumatological impairments

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: Up to 12 weeks
Secondary outcomes:
measure: Visual Analogue scales
timeFrame: Up to 12 weeks
measure: Ankle Range of Motion
timeFrame: Up to 12 weeks
measure: Plantar Fascia thickness
timeFrame: Up to 12 weeks
measure: Quality of Life (QoL)
timeFrame: Up to 12 weeks
Other outcomes:
measure: Satisfaction
timeFrame: Up to 24 weeks
measure: Participant characteristics
timeFrame: week 1
measure: Recruitment and drop-out rates
timeFrame: Up to 24 weeks
measure: Feasibility
timeFrame: Up to 24 weeks
measure: Effectiveness of blinding
timeFrame: Up to 12 weeks
measure: Cost
timeFrame: Up to 24 weeks
measure: Adherence
timeFrame: Up to 24 weeks
Locations:
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
state: Devon
Study officials:
affiliation: Plumouth University
name: Jonathan J Marsden, PhD
role: STUDY_CHAIR
affiliation: University Hospital Plymouth NHS Trust
name: Richard McKee, B.Sc.(Hons)
role: PRINCIPAL_INVESTIGATOR
References: