Barefoot Science insoles show remarkable benefits within an NHS study

Originally published on All About Balance UK by Dr. Stuart Gordon

In an NHS Innovation approved study 999 out of 1000 patients chose to buy Barefoot Science insoles rather than receive free NHS orthotics.

Steps towards modernising the treatment of musculoskeletal pathomechanics

A study within the NHS Innovations programme by Mr Neil Frame DPodM MChS – Podiatry Specialist (Biomechanics) – November 2015

The Project and Need

Technological advancement drives our approach to healthcare more today than ever. There is growing awareness in the NHS that treatment protocol and pathways redesign requires pace matching with technological reformatory advancements. There is a developing and necessary theme to find solutions that address the ‘cause’ rather than accommodating the symptoms. 

Following the introduction of Barefoot Science proprioceptive stimulating insoles as a treatment over 3 years ago, it has become apparent that due to the insoles benefits, future work (beyond this 3 year observational period) will build on the introduction of such technology, working to uptake universally throughout the NHS, to (allow all patient groups the alternative of experiencing the benefits) enable more groups of patients to benefit from it’s rehabilitative and preventative capacities.

Considering that musculoskeletal conditions can encompass as many as 200 disorders affecting joints, bones, muscles, and soft tissues, with the prevalence of these conditions rising with age 1,2, this system will be of wide patient benefit. To give an indication of the demographic benefits that Barefoot Science technology may bring, it is estimated that there are just over 3 million adults in the United Kingdom who are disabled by a musculoskeletal condition. Furthermore, musculoskeletal disorders were the most common type of self-reported chronic illness in all recent General Household Surveys (GHS) with 16.3% of women and 12.2% men (14.3% of all adults) affected.

The duration of treatment for such chronic musculoskeletal conditions can range from several months to years or even permanency and this should be taken into account when considering the impact and viability of alternate care pathway such as Barefoot Science technology. It is estimated that in Lancashire-12 districts, there are approximately 77,168 males and 109,029 females in just this demographic, with musculoskeletal conditions (Parsons et al) 3.
Prevalence increases with age with 1 in 5 adults aged 50–59 to almost 1 in every 2 adults aged 80+ having painful osteoarthritis in one or both knees (Peat et al, 2008) 4. There are approximately 20,000 new cases of rheumatoid arthritis in the UK every year. There are around 400,000 adults in the UK with rheumatoid arthritis.

With the UK population aged over 50 projected to rise by 32% between 2008 and 2030, this trend is expected to continue. It is estimated that in 2008, up to 1 in 4 general practice consultations were for musculoskeletal problems at a total cost of over £186 million to the NHS. Disease ‘burden’ can be defined not only by the number of people affected, i.e. incidence and prevalence, but also by its social, economic and personal impact. The Health and Safety Executive estimate 8.8 million working days in 2008 were lost due to musculoskeletal conditions. Benefit data show that, in the first quarter of 2009, 12% of those on the incapacity claims system were claiming for musculoskeletal conditions.

Project Partners

Barefoot Science, a company based in Toronto, Canada, was founded in 1997 to further explore, patent, and market insole technology to the foot care industry. Over one million insoles (historically aka ‘Dynopro’) have been dispensed.

Objective supportive data of product’s efficacy from companies and equipment supplied by:

1. Tekscan (F-Scan System), 307 West First Street, South Boston, Massachusetts 02127-1309, USA. (Under Foot Pressure and Impact Observations using a F-Scan Data Collection System) – File 1 attached2. U.S Military, Project Report: Special Operations Medical Association (Barefoot Science Verified and Validated). Noraxon U.S.A. Inc, 15770 North Greenway-Hayden Loop, Suite 100 Scottsdale, Arizona 85260, USA. (Project Report: Special Operations Medical Association – Barefoot Science Verified & Validated). 21 December 2012
– File 2 attached

3. Microgate (Optogait/Gyko), 13284 Pond Springs Rd, #102 Austin, Texas 78729, USA
– File 3 attached

Research emanating from:

1. University of Huddersfield, Queensgate, Huddersfield, UK. 30 October 2010. – File 4 attached

2. On the use of insoles to alter walking ground reaction forces, 3D kinematics and EMG following an 8 week intervention. Janessa Drake, Brendan Cotter, Alison Schinkel-Ivy. York University, Toronto, Ontario, Canada. 2015, – File 6 attached

3. Staffordshire University, College Road, Stoke-on-Trent, Staffordshire. Due 2016.

Recognised practitioners have embraced this technology globally for twenty years.

Project Delivery

Barefoot Science was first presented as a treatment alternative in August 2012 when it was first available in the UK, being introduced as an option to patients being treated for common musculoskeletal symptoms associated with proprioceptive deterioration, pathomechanics, systemic conditions and resultant pathologies.

Patients are now counselled regarding this option availability, care being taken to clearly explain that there is a traditional approach, one that may result in free insole provision and Barefoot Science insoles only being available via self-funding.

The counselling during consultation would take the format of a full description of the two options; the new insole being described as engaging the musculoskeletal system through a parasympathetic ‘switch’ that progressively and semi-permanently redefines the functional parameters of the body during movement. On the other hand, traditional insoles involve ground reaction force modification, through a wedging and foot arch realignment to alter functionality, allowing the foot to be protected and heal whilst in situ. The new insole delivers a progressive, functional realignment with the primary advantage of removing the necessity of having to wear the insole continually. It has the affect of positive, postural realignment emanating from foot level, thus allowing the body to ‘learn’ through the stimulation of the neuromuscular receptors in the plantar surface of the feet to maintain functional efficiency, on it’s own volition5.

Presently, patients are unable to obtain the new alternative free of charge in the NHS and are required to purchase direct from the commercial supplier.

This new approach to an age-old affliction the feet losing their ability to self-support caused by the wearing of footwear, obesity, pregnancy, occupation and disease can now be treated by a safe and effective alternative.

This technology, through prevention or resolution has the potential to improve safety of care, encourage a culture of prevention, rehabilitate more effectively and as a natural consequence reduce NHS pharmacology spend (while dramatically reducing repeat visits.) This case study aims to propose a modern alternative in the treatment of commonly occurring musculoskeletal pathologies treated in the NHS, ensuring all regulatory conditions are met and evidence base practice is recognised and addressed through the reformulation of relevant NICE (National Institute for Health and Care Excellence) guidelines.

This excursion into a new philosophy of treating conditions that are a consequence of over pronating feet, systemic conditions and a plethora of functionally related pathomechanics are now being treated with this safe and effective insole; the patient expressing their own preference by purchasing the Barefoot Science insole option.

Patient benefits, including any patient reported feedback

The prescription of the proposed insole will enable patients requiring musculoskeletal rehabilitation and those looking for injury prevention to receive effective remedial intervention that promotes safe, independent mobility, including high risk, vulnerable people, thus reducing the burden on professional input, outpatient services and budgets.

Shortages of therapists, trained exercise instructors and pressures on the delivery of NHS services urgently require the development of new methods of working in order to meet health needs of the population. A progressive exercise and rehabilitation intervention, that is safe to undertake for all is required to assist therapy staff, one that would be more cost effective and pro-active, promoting a preventative approach to improve function and quality of life.

Sample patient letter (prior permission for publication granted):

"Thank you for introducing me to the ‘Barefoot Science’ system of shoe inserts – they have changed my life completely. As a young man I enjoyed ‘outward bound’ adventures with HM Armed Forces and later as a civilian; mountain and country walking.

Fifteen years ago I started living with Rheumatoid Arthritis and in due course I couldn’t walk without the aid of walking sticks. My lower left leg bones (fibula, tibia and ankle) started to become deformed.

ln 2005 both my knee joints were replaced and eventually my life started to change and I began to be able to walk without walking sticks again.

Both my feet have also been affected by the Rheumatoid Arthritis and having seen various chiropodists I was referred to yourself as a ‘biomech’ by my GP and you introduced me to bespoke shoe inserts made in your workshop, which ‘made a difference’, but in due course you suggested that I became involved in a ‘trial’ using the’ Barefoot Science’ system.

By the Barefoot Science method of using adjustable thicknesses of ‘flexible shims’ with the shoe inserts, the Barefoot science system has enabled me to find my personal levels of adjustments that I needed, to enable me to walk better than I have been able to walk for years.

You have recently transferred me from the Barefoot Science General Purpose system to the Therapeutic System and also how to select the necessary Barefoot Science method of ‘therapy’ for each foot separately and independently from each.

During the past two years I have been able to enjoy some very short country walks again and since being introduced to the Barefoot Science system I am now able to walk 5 mile walks with rambling groups. I have recently led 3 different 5 mile walks with different walking groups too.

Because I still live with the ‘energy disease’ rheumatoid arthritis, following a 5 mile country walk, it takes menthe whole of the following day to recover from the energy consumption of the walk on the previous day – but my feet don’t really suffer at all.

Thank you again"

Terence David Moore
Stockport NHS FT Hospital Governor & Manchester NHS University FT Hospitals Trust Member

– File 7 attached.

System benefits including any cost savings

User involvement has already been engaged in the preparation of this proof of concept project.

• Discharge numbers have increased due to the resolution of the initial presenting pathomechanical related symptoms and perceived patient autonomy and self-care.
• Common musculoskeletal conditions such as osteoarthritis are the dominant cause of chronic pain, disability and work loss in the UK, more than 6 million people having painful osteoarthritis in one or both knees.
• Prescription of this technology will be suitable for patients with a wide range of pathomechanical related musculoskeletal conditions including;
• early onset osteoarthritis,
• rheumatoid arthritis and
• diabetes.
• Barefoot Science insole stands to improve the prognosis of patients with diabetes, where in the UK alone 3.3 million cases of type 2 diabetes are diagnosed annually, requiring 10% of NHS medication funding for the care and control of their condition. As a result of diabetes and systemic complications, 130 amputations are recorded weekly in the UK (statistics from Diabetes UK).

Barefoot Science Technology, under clinical supervision will:

• deliver safe, preventative and effective care pathways – that includes patients that have complex needs requiring rehabilitation – thus reducing hospital length of stay,
• make effective use of ‘the appropriate first point of contact practitioners i.e. general practitioners (GP) promoting effective triage pathways that reduce waiting times,
• reduce the number of expensive specialist referrals for pathologies such as falls, pes planus and the related ankle to shoulder misalignment issues associated with a dysfunctional foundation and lack of proprioceptive stimulation. Effective in the treatment of for example; plantar fasciitis, Achilles tendinopathy, ankle and shin syndromes, patella femoral maltracking, iliotibial band symptoms,
• effective education to the masses as it relates to the importance and role of a healthy, strong, functional biomechanics.
• reduce dependency on health and social care support and associated costs,
• deliver significant cost savings and reduce longer-term support costs,

• deliver high impact change to healthcare that requires new ways of working to ensure effective rehabilitation can be delivered to patients with long-term conditions,

• it can be anticipated that the introduction of Barefoot Science insoles at primary care level has the potential to help prevent the effects of conditions including multi-joint osteoarthritic pathologies and those resulting from the diabetes complications that involve the musculoskeletal system and thereby benefit symptoms, function, reduce medication with quicker response times to intervention with additional cost savings to the NHS.

• QIPP- aiding to demonstrate Quality Innovation Productivity and Prevention agenda – assisting in fall prevention, improving recovery times post surgical procedures to the lower limb,

• Supports QOF (Quality and Outcome Framework) – improve clinical care, enhances organisational excellence through better information for patients; education and training; and practice management, improve patient experience,

• Demonstrate the use of evidence based practice.

Next steps to a sustainable project

• The next steps will circle around education and patients about the role and benefits of introducing enhanced proprioception to the foot,

• insole accessibility is necessary through successful Drug Tariff application and NHS Supply Chain, entering the existing podiatry insole category,

• a user friendly curriculum and continuing education programme will be made available to GP and musculoskeletal front line practitioners,

• effective web portals will be available to empower patients, encouraging further research of the technology, feed-back and participation,

• ongoing additional peer studies with NHS supported research teams will be a continual project,

• keynote speakers will to be integrated into the nationwide healthcare conferences and seminars,

• a drive for continuing collaboration with global companies, such as Microgait that have integrated their gait, balance, alignment and posture technologies into assessment and rehabilitation clinics,

• an approach utilising technology moving healthcare to an accountable, evidence based, ‘assess, implement change and re-assess’ model needs to be adopted, with Barefoot Science integrated as one of the key components in the core tools at the ‘implement change’ phase,

• Arthritis Research UK have recently awarded funding to the Keele University CAT Bank for a large review study on the treatment of plantar fasciitis, the author being a podiatry member of this group. The Keele CAT Bank comprises of a group of clinicians and academics from the Keele centre and local PCTs that look at answering clinical questions. These are called critically appraised topics (CATs). They are then made available to staff and researchers and help to inform clinical practice and the formulation of new research questions within the centre. This may prove to be an ideal test bed for the Barefoot Science insole technology; it’s application and treatment for common musculoskeletal pathologies, such as plantar fasciitis.

Healthcare in the UK is moving into a rapid transitional phase and at such a pace that the timely exploration of innovation such as Barefoot Science insole Technology presents us with an opportunity to close the widening gap between technological advancement and the practitioner.

REFERENCES
1. Office for National Statistics (2009). Statistical Bulletin. General Lifestyle Survey – Health Tables 2009. Tables 7.11,

2. Arthritis Care (2011). Report. Understanding Arthritis,

3. Estimate of Musculoskeletal conditions in Lancashire (based on 2011 Census resident population),

4. Gender difference in symptomatic radiographic knee osteoarthritis in the Knee Clinical Assessment – CAS(K): A prospective study in the general population. Rosie J Lacey, Elaine Thomas, Rachel C Duncan and George Peat,

5. McKeon PO, et al. Br J Sports Med 2015; 49:290. doi:10.1136/bjsports-2013-092690 – File 5 attached,

APPENDIX

Further trials:

1. Toronto East General Hospital ER Nurses and Doctors pain and fatigue study. Ned Amendola MD Surgeon Sports Medicine Orthopaedics Duke University, Dr. Peter Fowler Chief Medical Officer for the Qatar Orthopaedic & Sports Medicine Hospital, Corinne Hodgins MSc, CSH Associates – File 8 attached,