Precis - Spinal cord stimulator

NEW SPINAL CORD STIMULATOR OFFERS EFFECTIVE ALTERNATIVE TO LONG TERM USE OF
PAIN RELIEVING DRUGS

The release of a new breakthrough in drug free pain relief is announced this week by Acticare, a Bristol based medical company. The device, called Acticare TSE, is a pocket sized nerve stimulator which works directly on the central nervous system using pads placed over the spine. Invented by Dr Alex Macdonald and Dr Tim Coates, a study completed this month indicates that the device may be a significant advance in non-drug treatment for chronic pain.

Dr Macdonald explains “We studied 150 patients who used Acticare TSE over a period of two months or more. Of these people, more than 3 out of 4 (79%) said that they had 50% or more relief of pain. This is an excellent result
considering the average duration of pain reported was 9 ½ years and the conditions they suffered represented some of the most difficult to treat. Of average age 66 years, most of the patients had already tried many different pain interventions, both conventional and alternative in an attempt to manage their pain. We hope people will use this method in the very early phases of their condition to prevent such suffering in the future”.

An additional benefit is that that people using TSE need to see their GP less frequently, research has indicated a 38% drop in GP visits, and also report an improvement in mood.

Chronic pain affects one in five of adults in the UK, many sufferers feel so bad that they become depressed and imprisoned in their homes due to lack of mobility. New treatments for chronic pains are of crucial importance in the light of the current controversy over long term use of pain relieving drugs. Gastric problems associated with long term use of non-steroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and aspirin are of concern to many doctors and patients. This spurred the development of a new class of NSAIDS known as Cox-2 inhibitors or coxibs, which were originally thought to be safer. However, last September, Merck withdrew it’s coxib,Vioxx, when a study suggested a risk of heart attacks and strokes. In contrast, electrotherapy techniques such as 'TENS' (Transcutaneous Electrical Nerve Stimulation) offer good relief for conditions such as nerve pains without the risk of side effects.

Dr Macdonald continues “A problem with TENS machines is that pain relief is localised in the region of the pads. We were looking for a therapy with the convenience of TENS that offered pain relief anywhere in the body without drugs or surgery. We first devised a bed-side electrical spinal stimulator that was very effective in a clinical trial. However, our patients needed a portable unit, which we developed in 1997, but at the time the semiconductor technology was not sufficiently advanced to allow us to deliver the therapy at full power. Nevertheless, around 8,000 patients benefited and 150 pain clinics across the UK used it.”

“The new Acticare device, launched today, has taken two years and cost more than £500,000 to develop. It is the first machine that has the power it needs to be as effective as possible, together with the portability that makes it easy to use at home.”

Spinal Stimulators that use electrodes surgically implanted in the spinal canal are in common use for the treatment of severe chronic pains. However, this is the first electrical therapy that acts on the central nervous system through electrodes placed on the skin. In recognition of this, Drs Macdonald and Coates were granted patents on the therapy in the UK and USA.

TSE stands for Transcutaneous (through the skin) Spinal Electroanalgesia (electronic pain relief). It works by suppressing pain signals in the spinal cord using very short but intense electronic pulses via electrode pads on the back or neck. Even though the device produces ten times the power of a typical TENS device you can buy in the shops, only a mild tingling sensation is felt during treatment. This is because the impulses are so short that the nerves cannot react quickly enough to ‘feel’ them.

“It’s taken many years of effort to get where we are today, but thanks to all those involved we believe the new Acticare TSE device represents a significant advance in the technology of pain management. There are three major advantages of the method: it works on multiple pains anywhere in the body with standardised pad locations over the spine; it can be used in addition to any other form of therapy – for example, it does not interfere with drugs, manipulation, acupuncture etc – in fact it tends to make other forms of therapy more likely to be effective; and above all it can be used at home without any practitioner being directly involved, whenever it is needed”.

“Previously we believed that TSE was only effective for chronic pain. But the new Acticare TSE device has an increased power output that allows it to treat both chronic pain and acute pain from new injury - even when
inflammation is present.”

Caroline Harrison, 38, from Clevedon near Bristol, tried Acticare TSE recently following a shoulder injury sustained when she fell from her horse. Caroline said: “I aggravated my collar bone that I broke at 18 when I fell from my horse; I was in severe pain, so much so that I had to struggle to drive to work. A friend offered me the use of a TSE machine, placing the electrodes across my neck. After about an hour I was surprised that the pain had gone away as if by magic. I remained pain free for two days following that first treatment. Acticare TSE allowed me to get straight back to my busy life.”

Dr Tim Coates, co-inventor, said: "We are very excited with the results we are achieving with this new device. TSE is simple to use for self treatment at home. We also offer a telephone helpline staffed by medically trained personnel for those that need advice”.

TSE devices are available at the introductory price of £149 from
www.acticare.com <http://www.acticare.com/> or 0800 028 1400.

Notes

The age of modern electrotherapy started in 1967 when Drs Pat Wall and Ron Melzack described their 'gate control' theory of pain reduction that led to the development of the first 'TENS' devices. TENS is now widely used to treat chronic pain, although patients can require many hours of treatment and may find the tingling sensation produced uncomfortable. Controlling chronic pain by stimulating the spinal cord was achieved shortly afterwards using implanted stimulators. These 'SCS' (Spinal Cord Stimulation) devices are increasingly used, particularly in the USA.

Acticare TSE is a product of a Bristol based company, Bioinduction Ltd, trading under the name Acticare. Bioinduction Ltd owns the patents to TSE therapy, which have been granted in the UK and USA with further patents are pending world-wide. Drs Macdonald and Coates are shareholders in the company, which was formed in 2002 with Mr Ivor Gillbe as Managing Director. The inventors take a keen interest in management of the company. Bioinduction employs seven people at its Bristol office. It has also just opened a new office in Brisbane Australia with another in the pipeline in Canada.

The effects of TSE include relief from all types of chronic pain and an improvement in mood. A controlled study of 60 patients conducted in the University of Westminster revealed significant changes in mood when electrodes were placed over the spinal cord. Following high intensity stimulation, TSE subjects felt “significantly more elated, leisurely and less tense”.

A formal, randomised, double blind, crossover clinical trial performed by Macdonald and Coates comparing TSE (at a frequency of 10kHz) with a control form of stimulation (TENS) for the relief of chronic pain, showed the analgesic effects of TSE to be significantly superior.

Another study of 60 patients showed that people using TSE needed to see their GP's less frequently; the reduction in the GP consultation rate of people using TSE was 38.7%.

The simplicity of this therapy enables patients to assume control of their own pain management. It provides an appropriate and cost effective alternative approach to pain management that in many cases can reduce the
dependence of the patient on medical resources.

For further details and contact Ivor Gillbe at Bioinduction Ltd on 0117 377 5275 or mobile 07860 679 359 or ivor@acticare.com .

Address:
Bioinduction Ltd
178-180 Hotwell Road
Bristol BS8 4RP United Kingdom
Tel: 0117 377 5275
Fax: 0117 377 5405

(1/2/05)