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

NCT02212444 | Completed DMC

• 2 other identifiers: 14/P/05114/SW/0116
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis

Keywords

plantar fasciitis; dynamic elastomeric fabric orthoses (DEFO); feasibility; Physiotherapy; Musculoskeletal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual Analogue scales

  Up to 12 weeks

• Ankle Range of Motion

  Up to 12 weeks

• Plantar Fascia thickness

  Up to 12 weeks

• Quality of Life (QoL)

  Up to 12 weeks

Other Outcomes (7)

• Satisfaction

  Up to 24 weeks

• Participant characteristics

  week 1

• Recruitment and drop-out rates

  Up to 24 weeks

Study Arms (2)

Dynamic elastomeric fabric orthoses (DEFO)

EXPERIMENTAL

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)

Off-the-self orthotics

ACTIVE COMPARATOR

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

Interventions

Dynamic elastomeric fabric orthoses (DEFO) DEVICE

A patient customised dynamic elastomeric fabric orthoses (DEFO)

Also known as: DEFO

Dynamic elastomeric fabric orthoses (DEFO)

Off -the-shelf triplanar orthoses DEVICE

Off-the-self orthotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Calcaneal fracture
• Additional neurological or orthopaedic / rheumatological impairments

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Jonathan J Marsden, PhD

  Plumouth University

  STUDY CHAIR

• Richard McKee, B.Sc.(Hons)

  University Hospital Plymouth NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2014
• First Posted: August 8, 2014
• Study Start: June 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-06

Locations

GB (1)