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

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02212444
• Other study ID #: 14/P/051
• Secondary ID: 14/SW/0116
• Status: Completed
• Phase: N/A
• First received: August 4, 2014
• Last updated: June 2, 2016
• Start date: June 2014
• Est. completion date: January 2016

Study information

• Verified date: June 2016
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: National Health ServiceUnited Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Over 18 years old

• Plantar heel pain for greater than 3 months

Exclusion Criteria:

• Calcaneal fracture

• Additional neurological or orthopaedic / rheumatological impairments

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Device:
• Dynamic elastomeric fabric orthoses (DEFO)
A patient customised dynamic elastomeric fabric orthoses (DEFO)
• Off -the-shelf triplanar orthoses

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction	A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.	Up to 24 weeks	No
Other	Participant characteristics	The following patient characteristics and risk factors for the development of plantar fasciitis will be taken at baseline: Age, gender; Duration of plantar fasciitis; Body mass index; Occupation and average hours standing per day; Physical activity (International Physical Activity Questionnaire; The number and type of hip / trunk exercises prescribed after the initial assessment by the treating therapist.	week 1	No
Other	Recruitment and drop-out rates	Data on recruitment and attrition rates will be entered into a database. Where possible, reasons for dropping out will be ascertained; Percentage of completed measures at each time-point: The percentage of completed measures at each time-point for each participant will be entered onto a database	Up to 24 weeks	No
Other	Feasibility	At the end of the study participants and PHNT staff will complete a questionnaire on the feasibility of the study and provide suggestions that may aid the running of future trials	Up to 24 weeks	No
Other	Effectiveness of blinding	Following each measurement time point the assessor (RM) will be asked to indicate which group they think the participant was allocated to.	Up to 12 weeks	No
Other	Cost	Unit cost of each orthotic intervention (off-the-shelf orthotic Vs DEFO) will be gathered to help inform future economic evaluations. This will include an estimate of the time required to take the different measures required for fitting and ordering each orthosis.	Up to 24 weeks	No
Other	Adherence	A questionnaire, developed for the purposes of this study, will ascertain people's satisfaction with the DEFO/orthoses and their adherence to treatment over the previous week. This will be assessed 12 and 24 weeks (via post) after issuing the orthotic.	Up to 24 weeks	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Plantar Fascia thickness	The thickness of the plantar fascia enthesis will be measured using ultrasound.	Up to 12 weeks	No
Secondary	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	No