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Case Study 1:
“A new treatment for the agony of stiffness”
This time last year, Angela Martin, 63, was in so much pain that she even contemplated suicide. In 1994, the keen golfer had been diagnosed with the incurable tendon and ligament disorder, fibromyalgia. Over time, her symptoms worsened until she suffered from agonising stiffness and pain throughout her body. “I had to give up golf because I could no longer bend down to pick up the ball,” recalls Mrs Martin, a widow who lives alone in Bewdley in Worcestershire. “The pain was constant and unbearable. I went to see my doctor but he said there was nothing more he could do. I was in complete despair and I could not see a way out of my misery.”
Now, she is almost pain free, thanks to an innovative device which is due to be unveiled at the annual Pain Society meeting in Manchester later this month. (30 March). Mrs Martin is one of the first chronic pain sufferers in the UK to try out an Electronic Nerve Modulator, (ENM), developed by GP, Dr John Royle. At the meeting, Dr Royle, who practises in Great Harwood in Lancashire, will announce the results of a double blind placebo controlled trial, which show that the new technology can dramatically ease severe pain by nearly 40 per cent after just one week's treatment. Conventional drug treatments rarely achieve this kind of improvement, and the relief often comes with a host of nasty side effects. Delegates will also learn that 87 per cent of patients in the trial derived benefit from the device, either through pain control or better sleep.
The announcement comes at a time when one in seven people in the UK suffer from chronic pain, according to the Pain in Europe 2003 survey. Around 56 per cent of chronic pain sufferers are women and over half of them endure pain every day of their lives. Not surprisingly, a quarter of pain sufferers have been diagnosed with depression.
The ENM device works on a simple principle. When we feel pain, nerve signals are sent from the injury site through the spinal cord and finally to the brain. Electrical energy can interrupt nerve signals on their way through the spinal cord, effectively blocking the ache. This is the basis for a complex and expensive surgical procedure known as Spinal Column Stimulation, where wires are implanted directly into the spine. Very few NHS patients are offered this tried and tested treatment, partly due to the expense- around £15,000 - and also because of the potential hazards.
The ENM achieves the same result, but without any need for invasive surgery. Instead of wires inside the backbone, electrodes are placed on the surface of the skin, over the spinal column. Patients wear the device for half an hour twice a day. This is sufficient to block painful stimuli for the entire 24 hour period. Dr Royle has modified the waveforms so that the electrical current penetrates up to five centimetres through tissue to the central nervous system.
Although it uses electric impulses, the ENM is different from TENs machines, which are low voltage and only stimulate the nerves just under the skin. “I realised that we needed something which would penetrate much deeper,” says Dr Royle. “TENS machines provide a form of distraction therapy and work because they cause a localised tingle. I wanted to actually block pain signals on their journey.”
Dr Royle's device delivers 2700 bursts of high energy every second. Patients feel no sensation because each burst only lasts for 30 millionths of a second- not enough time to register on the peripheral nerves. There is also no local tissue damage or burning.
The ENM devices, which are the size of small personal stereos, are also very cost effective. They each cost around £150 and use an inbuilt rechargeable battery, a bit like a mobile phone. Patients can easily use them on themselves, without the help of a nurse. One electrode, on a sticky pad, is placed on the lower spinal column, the second at the base of the neck. Studies also suggest that the pain relief is just as effective if the two pads are placed either side of the neck. Another advantage is that patients can get relief without the use of drugs. Non-steroidal anti-inflammatory drugs are commonly prescribed for people suffering from chronic pain, but they can cause nasty long term side effects such as internal bleeding and ulcers. 60 per cent of people who are prescribed these drugs say that they are “somewhat effective” at best.
Certainly, Angela Martin, who is not even popping the odd Paracetamol these days, is in no hurry to give hers back. “It changed my life. I was at my wits end, and now I can do things I used to enjoy like arranging the church flowers. I wouldn't do without my ENM for all the tea in China.”
The above case study formed the basis of an article printed in the Daily Telegraph on 31st March 2004.
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