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

NCT ID: NCT02212444

Last Updated: 2016-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2016-01-31

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.

Conditions

Plantar Fasciitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: SINGLE

Study Groups

Dynamic elastomeric fabric orthoses (DEFO)

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.

Group Type: EXPERIMENTAL

Dynamic elastomeric fabric orthoses (DEFO)

Intervention Type: DEVICE

A patient customised dynamic elastomeric fabric orthoses (DEFO)

Off-the-self orthotics

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.

Group Type: ACTIVE_COMPARATOR

Off -the-shelf triplanar orthoses

Intervention Type: DEVICE

Interventions

Dynamic elastomeric fabric orthoses (DEFO)

A patient customised dynamic elastomeric fabric orthoses (DEFO)

Intervention Type: DEVICE

Off -the-shelf triplanar orthoses

Intervention Type: DEVICE

Other Intervention Names

DEFO

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan J Marsden, PhD

Role: STUDY_CHAIR

Plumouth University

Richard McKee, B.Sc.(Hons)

Role: PRINCIPAL_INVESTIGATOR

University Hospital Plymouth NHS Trust

Locations

Plymouth Hospitals NHS Trust

Plymouth, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

14/SW/0116

Identifier Type: OTHER

Identifier Source: secondary_id

14/P/051

Identifier Type: -

Identifier Source: org_study_id