Pa i n Re l i e f Trea tmen t

Contents

Case Studies ............................................................................. page 14

SpineCor Treatment Results .................................................... page 16

Treatment Cost Information ...................................................... page 18

Patient Stories........................................................................... page 12

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Information on Scoliosis .......................................................... page 3

SpineCor Treatment Information ............................................. page 7

The SpineCor Pain Relief Back Brace .................................... page 4

What is scoliosis?

i) Degenerative Adolescent Idiopathic Scoliosis

ii) De-novo Scoliosis(a degenerative scoliosis spontaneouslyoccurring in adult life)

What is Hyperkyphosis?

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Correction ClinicsSpecialists in spinal correction, stabilisation and pain relief

Spinal

Principally Scoliosis is a sideways (lateral) curvature, combined with a corkscrew like twisting effect of the spine (rotation).

There are two main types affecting adults:

(adult degeneration of a curve thatdevelops in adolescence)

Hyperkyphosis is a condition where the curvature in the thorax (Kyphosis) increases, causing a round back and stooping forwards. Such deformities can develop during growth as a child and worsen during adult life, but often the onset is the result of degenerative changes later on in life. Such imbalance often causes pain and can result in stress fractures.

Healthcare UK Limited has been providing clinical services since 1999.

Healthcare UK Limited's Spinal Correction Clinics have been established to provide optimal treatment to patients with spinal deformity. Our multidisciplinary teams have extensive experience in the treatment and management of spinal deformities in both adults and children.

Patients are fully assessed and only offered appropriate treatment with clearly advised objectives and prognoses.

The SpineCor® Pain Relief Back Brace

IndicationsThe SpineCor® Pain Relief Back Brace is primarily aimed at treating back pain related to:

• Adult De-novo Scoliosis

• Degenerative Adult Adolescent Idiopathic Scoliosis

• Hyperkyphosis

• Postural Scoliosis

• Chronic Antalgic Scoliosis

• Post Traumatic Scoliosis

• Spinal Stenosis related to spinal misalignment

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An innovative approach to spinal treatment in adults, providing targeted pain relief by postural rehabilitation and spinal offloading.

Clinical experience during the two year development of the brace involving 200 patients has demonstrated pain relief within a few hours of being fitted, and in most cases 90% reported relief within six weeks of use. The brace is typically worn 8-16 hours per day in order to initiate changes in posture. After several months of wear, it is often possible to reduce the wearing time and maintain the same level of pain relief.

Additionally the brace may be used to improve posture and potentially to reduce curve progression.

SpineCor® Healthcare UK Ltd offers SpineCor® treatment consisting of a custom-fitted brace system which requires regular review appointments to ensure maximum effectiveness of the treatment.

Treatment Objectives

1. Pain:

2. Posture:

3. Progression:

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The primary treatment of the SpineCor® Pain Relief Back Brace is pain relief. However, postural improvement is directly related to pain relief and is therefore an added benefit.

The postural changes achieved using this brace are patient specific and are defined by the clinical and radiological features of the patient’ s condition. Often, the postural changes seen can result in the stabilisation or correction of progression and reduction in pain.

Correction and stabilisation of spinal deformities or misalignments. In these cases, radiological evaluations are advised to optimise treatment. Radiological objectives may include optimisation of spinal balance, reduction of spinal decompositions and the possible reduction of Cobb angles. Please note, significant correction of Cobb angles in adults will rarely be possible and should not be a significant treatment objective.

Brace Components

The SpineCor® Pain Relief Back Brace is made up of two sections:

It is advised that patients wear a bodysuit under the SpineCor® brace:• To keep the brace cleaner for longer.

•

• To facilitate going to the toilet by detaching the snaps of the bodysuit.

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1PelvicShorts

2Bolero

3Corrective

Bands

The first section consists of the pelvic shorts (1). The shorts act as an anchoring point and supports the actions applied to the patient’ s trunk by the elastic corrective bands.

The second section consists of the bolero (2) and the corrective bands (3). This is designed to apply the corrective movement to the scoliosis/spinal deformity.

The fitting of the corrective bands is specific for each patient and depends on the patient’s type of curve/spinal deformity.

To add comfort by providing a barrier between the brace and thepatient’s body, reducing the likelihood of the brace rubbing.

SpineCor Treatment Information

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SpineCor Assessment Appointment

An initial assessment appointment is required to confirm your suitability for SpineCor treatment.

A detailed assessment will be made of your medical history. Your x-rays will be reviewed and clinical examinations will be undertaken.

Recent x-rays of the spine are necessary to determine the treatment suitability. If recent x-rays are unavailable, then x-rays can be arranged to be taken at the time of the assessment appointment if required.

A letter of referral from your GP or Spinal Consultant will be required prior to this appointment to confirm whether you will be suitable to proceed with treatment.

During the treatment appointment, we will carry out more detailed evaluations before fitting the SpineCor brace:

SpineCor Treatment Appointment

Clinical evaluation: to evaluate any postural abnormalities.

X-ray evaluation: to evaluate your type of curve.

Postural Evaluation: to evaluate your postural abnormalities by visual evaluation of your spine and simple measurements being taken, using a laser plumbline, scoliometer, protractor and ruler.

SpineCor® Assistant Software: a computer will record data from all our evaluations and calculate your specific curve classification. The software will also specify the exact brace fitting details for you.

SpineCor® Physiotherapy Programme

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At the end of the visit we will explain how to fit and take off the brace (don't worry, it is very easy!).

It is recommended that patients visit their clinician for regular readjustments to the brace for the duration of their treatment.

To further enhance and improve the treatment, we may recommend that the patient undergoes a physiotherapy programme.

If required, patients may also be prescribed a shoe lift at the time of the brace fitting.

To optimise the dynamic effect of the brace, we would encourage patients to perform any type of sport WEARING the brace (except for swimming).

The SpineCor Physiotherapy Programme has been designed to complement the effects of the brace and reinforce the patient’s treatment.

Each patient will be prescribed precise exercises for their specific type of curve.

Patients should only carry out the exercises exclusively designed for their type of curve, according to the nature of their specific spinal deformation and postural disorganisation.

Frequently Asked Questions

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Is the SpineCor® Pain Relief Back Brace available on the NHS?This treatment is not yet available in the NHS. All consultations and scoliosis treatments are provided on a private basis only. In addition to the price quoted for bracing, separate fees will be payable for Spinal Consultant Surgeon consultations, x-rays and physiotherapy, when required.

Do patients need a GP referral?Yes. A referral is required from either a GP or Spinal Consultant prior to an assessment appointment.

Which treatment or treatment combinations will patients be offered?During the assessment appointment patients will be offered a treatment plan most suited to their needs, taking into account their preferences. If SpineCor treatment is not advised, then patients will be recommended to seek further advice from a Spinal Consultant.

Do patients need an assessment appointment prior to treatment?Yes. Our Clinical Specialists will review your medical history and make an assessment of whether SpineCor brace treatment may be an appropriate treatment for you.

Will patients be suitable for non-surgical treatment?Suitability can only be determined after an assessment appiontment and review of all necessary investigations by our specialist Spinal Clinicians.

Will patients need x-rays during the assessment and treatment?Yes. Unless patients already have relevant recent x-rays that they are able to bring with them to their assessment.

Related to:

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Adult De-novo ScoliosisDegenerative Adult Adolescent Idiopathic Scoliosis Hyper KyphosisPostural ScoliosisChronic Antalgic ScoliosisPost Traumatic ScoliosisSpinal Stenosis related to Spinal misalignment

Pain Posture Progression

What are the indications for SpineCor® treatment in adults?The basic Indications are spinal deformity:

How does the SpineCor® Pain Relief Back Brace work?It changes the patient’s posture from one which mechanically drives progression of the curve to one that minimises it. This is achieved by postural rehabilitation which not only changes posture and spinal shape but also spinal loading, therefore reducing pain often caused by abnormal spinal loading.

How long do patients need to wear a SpineCor® brace for?This depends upon the severity of the problem and the treatment objective. Generally there will need to be some intensive periods of wear followed by a reduced period of daily wear. Wearing can vary from a few hours a day to virtually full time.

Will patients need an MRI scan?Possibly. This will be advised during the patient’s initial assessment appointment.

How long does it take to establish suitability for SpineCor® treatment?Assessment visits normally take around 45 minutes excluding time taken for x-rays.

How long does it take to fit the SpineCor® brace?This depends upon the complexity of the case, but anything from one and half hours to three hours.

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How often do patients need follow-up on their treatment progress/brace adjustment?For adults an initial follow-up is generally recommended between 4 - 6 weeks, following this 3 – 6 monthly reviews may be advised depending on the severity of the problem.

Can physiotherapy alone benefit scoliosis?In some cases yes, however most patients in our clinics have already tried physiotherapy and found it to be of limited value on its own. In mild cases we may still advise physiotherapy alone prior to bracing if it is felt this might be sufficient. Sometimes physiotherapy is necessary prior to commencement of bracing in order for it to be effective. Generally physiotherapy is most effective when used in conjunction with bracing.

Will patients be recommended surgery?For some patients surgery may be overwhelmingly the best treatment and the provision of non-surgical treatment may even be negative. In such cases, patients will be advised to discuss this with a Spinal Consultant.

Is Physiotherapy treatment essential with SpineCor® treatment?No. In many cases SpineCor® treatment is sufficient. However, in some cases additional physiotherapy may be extremely beneficial, in which case it will be prescribed.

How do patients make an appointment?Contact one of our Clinic Co-ordinators on 01246 454682 who will assist you in making a convenient appointment to see one of our Clinical Specialists.

Patient Stories

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Siobhan's Story

After being diagnosed with scoliosis at age 14, I was given a choice of wearing a Milwaukee brace or taking part in a trial that entailed using a traction attached to my bed. Being a teenager, I opted for what I thought would be the easier option of the traction - at least no one would see me using it, I thought. All in all, it was not a good experience. I kept the traction for about three years, but I hardly ever used it properly. I was just delighted not to be wearing a brace! Naturally, in my case at least, the trial was not a success and I ended up having a Harrington Rod inserted just before my 21st birthday.

My right-sided thoracic curve was pretty bad by this time and after the initial surgery, I had to have two further operations to straighten out my ribs, which had become very 'humped'. The effect was good and I was discharged after a couple of years without any advice as to what might happen in the future - in effect, I thought I was cured and that was the end of it. I sailed through my twenties and most of my thirties without any problems at all and it was only after my second pregnancy at age 38 that I began to notice quite serious changes. My left-sided lumbar curve, which had always been much less serious than the thoracic one, had become much worse. I had a lot of lower back pain and one hip was higher than the other, as well as the whole pelvis seeming to shift to one side. I went to my GP who offered me painkillers and suggested I might need further surgery in the future. Having two young children, I was very keen to improve my quality of life, but wanted to avoid surgery at all costs.

I began to research scoliosis on the Internet, not sure what I was hoping to find. When I happened upon information about Spinecor, it seemed to make a lot of sense. I knew I was too old to hope for a correction of my scoliosis,but I wanted to do everything I could to prevent it becoming any worse, or at least slow its deterioration. I was also hoping for some reduction in pain.

After my initial consultation, I was fitted with my brace. When I was strapped into it for the first time, I thought that there was no way I would be able to tolerate it. All the way home on the train I felt very uncomfortable and couldn't wait to get home so that I could remove it. However,the next day, I decided I had to give it a chance so I put it on and went off to work. By the end of the week, I was almost unaware that I was wearing it. From the first day,my back pain disappeared completely. I have not had to take a single painkiller for back pain in the three years I have been wearing the brace.

In addition,my hips stay largely where they should,so I feel less like The Leaning Tower of Pisa! The only downside for me is that, especially during very hot weather, the brace limits my choice of clothing;however,this small problem is far outweighed by the benefits. I wear my brace for between twelve to fourteen hours a day now without a second thought. If I leave it off for a couple of hours, I do tend to start leaning again so,for me, I think I will not be able to reduce my hours. This does not mean, however, that I never allow myself a little brace 'holiday' now and again. If I want to wear a sleeveless dress for an evening out, I just take my brace off, secure in the knowledge that I can regain the benefits the next day.

I feel it's such a shame that I only happened to stumble on this treatment by chance. My GP and physiotherapist had not heard of it and were not encouraging when I mentioned giving it a try. I hope that this attitude is changing and that more people will be able to gain the benefits I have. I am fifty years old now and feel far more optimistic about my future. I do everything I want to: play badminton, swim, do all my own housework, and all without a twinge. I only wish I had heard of SpineCor years ago.

Zoe's Story

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Diagnosed at 14 although suspected at 11,

Milwaukee brace for two years (under Sheffield Children's Hospital), then I was discharged at the age of 16. There was no follow up treatment in those days. It felt a bit weird initially, but after a few months I don't recall having any major issues.

Over the years of my 20s I did find I needed extra treatment for aches and pains and I sought those from various disciplines; physio, then chiro probably till mid thirties.

In my 30s I had occasional bad spells, e.g lower back pain. One bout was significant enough for my Doctor to refer me back to Sheffield Children's Hospital. I saw Mr Douglas again; he was actually the in-coming consultant at the time of my regular visits during my teenage years and he recognised his own correspondence on my notes.

Now seeing me as an adult he did confirm (after an x-ray) that the pain I was experiencing was due to degeneration of the lower discs, but was of the opinion that nothing could be done for this lower back pain, other than see if Pain Killers could ease it. I was not accepting this and due to my persistence he did refer me to the Physio department to see if they could help. They introduced me to Pilates & after 12 months I was sorted; in much better fettle, and pain reduced considerably without the use of pain control. Other than that episode of lower back pain my main area of discomfort, if I was ever to encounter any, was usually mid-thoracic, around the area at the sharpest part of my curve. Have nicknamed "that" muscle as my "scoliosis muscle".

At 39 pregnancy & natural childbirth went very well. ....6 months post pregnancy the "scoliosis muscle" was up to its usual tricks...but far more frequently & severely than ever before.

Surfing the Internet I came across the SpineCor brace and read as many articles as I could. spoke to Tim Cook at length and my Pilates teacher, before deciding to go ahead and try it out. It was like it was made for me and I could not believe no-one had mentioned it before.

Amazingly, prior to coming across the SpineCor Brace I had asked if there were any braces out there, because I would be happy to go back into one. I really felt like I needed support. After further discussions we decided to give it a go... nothing to lose, but if we didn't give it a go there was nothing to gain. I already had x-rays and copies of my MRI scan that were useful during the consultation process.

I found the first month of wearing the brace a little disappointing as I did not feel much pain relief initially, so became a little despondent. However at my next appointment I was able to report differently and was relieved to be starting to experience some pain relief in the brace.

My overall opinion is that it has been a "Life Saver" for me... . I don't mind the discomfort in the slightest.. it far outweighs the pain I was suffering before. Now that I am over 12 months into this project and the Clinicians are happy with the results of the initial few months I now wear my brace when I chose... which is most work days.

At the weekends , if it is a day at home, I always start off in my brace because I am invariably doing jobs. If I am out then I don't wear it, but may put it on when I come back home.

Getting this more widely exposed has got to be the way forward if there are loads of other adult scoliosis pain sufferers out there.

This 26 year old female had a painful adolescent idiopathic scoliosis as an adult (ASA1). Her pain prior to SpineCor® treatment was rated as an average daily pain of 7/10.

Using the SpineCor® Pain Relief Back Brace, daily 8 to 12 hours for 3 months, she had a gradual relief of her pain to an average 2/10.

The initial x-ray shows a 32° right thoracic scoliosis. In the SpineCor® Pain Relief Brace 1 month after fitting the x-ray shows an improvement of 8° to 24°.

Her pain relief of 1-2/10 and spinal correction have been maintained for over 2 years by using the SpineCor® Pain Relief Brace on an occasional basis.

Pre-bracing Age 26 years

Female

First with brace x-ray

Case StudiesPatient 1

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This 47 year old female had a Degenerative De-Novo Adult Scoliosis. Her pain prior to treatment was rated as an average daily pain of 8/10.

In the SpineCor® Back Brace she had an immediate relief of her pain to 3/10. The initial x-ray shows a 40° degenerative lumbar scoliosis. In the SpineCor® Pain Relief Back Brace x-rays show an improvement of 7° to a 33° curve.

Her pain relief of 0-3/10 and spinal correction have been maintained for over 2 years by using the SpineCor® Pain Relief Brace on a daily basis. Note the improved left lateral shift showing “spinal off loading”.

Initial without brace x-ray Age 47 years

Female

First with brace x-ray

Patient 2

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Treatment Results

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How Much Does it Cost? A new simplified transparent pricing policy has been introduced, together with a staged payment plan to make SpineCor treatment more accessible to patients without insurance. Treatment for both adults and children is now charged at the same simple all inclusive price covering 12 months of treatment, regardless of complexity, number of follow up visits required or replacement parts required due to either growth or reasonable wear and tear.

12 Month SpineCor Treatment Plan * - £150 deposit plus 12 x £150 During your initial bracing appointment further detailed clinical measurements will be taken to establish baseline readings for optimising brace adjustment and future ongoing progress monitoring. The Brace will be fitted and adjusted according to clinical measurements prior to adjusted x-ray confirmation of efficient brace fitting. For children x-ray confirmation is always carried out on the day of brace fitting for adult patients x-rays are usually taken once the treatment has had time make some changes. Brace training is carried out to ensure the user and parent or carer fully understands the wearing program and how to fit the brace correctly. The cost of this treatment session including 12 months ongoing treatment follow-up for essential routine brace adjustments, maintenance and replacement parts is in total £1950, with two payment options;

1. £150 deposit (paid in advance of 1st appointment) plus 12 further monthly payments of £150 =£1950

2. £150 deposit (paid in advance of 1st appointment) plus balance of £1800 = £1950(payable on commencement of treatment)

In exceptional circumstances it may be necessary to combine the assessment and brace fitting appointments. A £300 deposit must be paid in advance of the appointment. Combination of scoliosis assessment and treatment appointments is only advised where there is reasonable certainty of treatment suitability.

* A Scoliosis Assessment is essential before treatment is commenced to establish suitability of treatment and the patients curve specific treatment plan.

Treatment Cost Information

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Scoliosis Assessment * - £150 Detailed review of the patient’s medical history, x-rays and clinical examinations is necessary to determine suitability for SpineCor treatment. Most patients seeking treatment will have already have been seen by a consultant spinal surgeon and have had their diagnosis confirmed, however this does not absolutely confirm suitability for treatment. Patients who have not recently seen a consultant spinal surgeon should obtain a referral letter from their GP providing relevant medical information to scoliosis clinician prior to assessment. Recent spinal x-rays of the patient’s spine are necessary for determination of treatment suitability; if recent x-rays are unavailable then further x-rays will need to be taken prior the assessment appointment. The cost of assessment is £150 (payable in advance of the appointment).

What is included? Scoliosis assessment, clinical base line measures, brace fitting, user brace education, routine brace follow-up appointments according to our protocols and complete brace including two body suits and all replacement brace components necessary due to growth or wear and tear.

What is excluded?a) Inclusive treatment costs cover your SpineCor Clinical Specialist only. Should referral need to be made to consultant surgeon or other specialist, then their charges will be billed separately.

b) The number of review appointments shall normally follow treatment protocol guidelines, inexceptional circumstances and at the sole discretion of your SpineCor Clinical Specialist, additionalreviews may be provided free of charge. Patient demands for additional reviews outside of protocolmay still be charged.

c) Replacement brace components shall be provided at the sole discretion of your SpineCor ClinicalSpecialist when judged necessary due to growth or wear and tear affecting the performance of thebrace. Body suits are not included in the free replacement policy due to wear and tear. Bracecomponents shall not be replaced purely for aesthetic reasons.

d) The cost of x-rays and any other imaging or diagnostic procedure are excluded from this plan all suchcharges will be billed to the patients directly by the hospital or imaging centre providing the service.

How much will x-rays cost?X-Ray fees range from £120 to £225, depending on the number of films required. These fees are set by the radiology company and are payable to their own offices.

How much will a Consultant Spinal Surgeon charge?Fees for a Spinal Consultations are approximately £200 and are payable to the Consultant's own offices.

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Healthcare© 2010 Healthcare UK LimitedAll rights reserved. No part of the contents of this manual or any images therein may be reproduced or transmitted in any other form or by any means without the written permission of Healthcare UK Limited.™SpineCor is a registered trademark of The SpineCorporation Limited

London, Sheffield, CambridgeHead OfficeMillennium House, Peak Business Park,Foxwood Road, Chesterfield S41 9RF

Tel No: 01246 454682 Email: info@healthcare.uk.netWeb: www.healthcare.uk.net

SpinalCorrection ClinicsSpecialists in spinal correction, stabilisation and pain relief

Manufactured in the UK