Is electric stimulation therapy a viable alternative when compression therapy is not tolerated?
That’s the current focus of a La Trobe University pilot randomised controlled trial investigating whether people with venous disease would tolerate an alternate regimen and, further, would they see benefit from it.
Studies have shown that for some patients compression therapy is not a tolerable option. Although extremely effective, common concerns include stockings or bandages being too tight, unattractive, itchy and hard to get on and off.
“The more compression you tolerate, the better the squeeze and the better the venous return,” Charne Miller, research fellow at the La Trobe University Alfred Health Clinical School says, highlighting that there are also many non-client focused reasons including cost, medical assessment and so on.
“The idea is that perhaps the people who are [unwilling or unable] to tolerate compression … might [find this] a more acceptable treatment.”
Electric stimulation is achieved through the use of a small portable device, in the case of this study the Bodyflow electrostimulation device. The manufacturers recommend use four times a day, about 20 minutes per session.
Benefits include, amongst others, improved systemic and peripheral circulation, promotion of muscle recovery and venous return and the reduction of risk of developing deep vein thrombosis and lung embolism.
Before the start of the current trial, the group of researchers at La Trobe undertook a case study, the findings of which were presented at the European Wound Management Association conference in Spain earlier this year.
The study focused on three clients who were all using low or no compression. Researchers found the treatment was well accepted and implemented with few difficulties.
Mrs E, aged 62 years, had been dealing with a venous leg ulcer for five months. She has been suffering from a wound about 2.5cm2 in size and using tubular compression intermittently. Using the electric stimulation therapy only twice a day for 20 minutes each session – less than the recommended use – her wound healed throughout the study.
Mrs J – 58 years old – had two wounds. She had one of 62cm2 on her left leg and one of 90cm2 on the right. She had been living with both for more than five years. Whilst her usage of the electric stimulation therapy varied, after 20 weeks she showed considerable improvement. The wounds decreased in size to 15cm2 on her left leg and 13cm2 on her right.
Although not healed completely by the end of the study – Mrs J did go on to heal entirely afterwards.
Mrs M, the third participant, was 84 with a wound of 21cm2. She was the one out of the group that didn’t observe a healing trend – the wound continued to fluctuate and was 74cm2 by the end of the study.
Miller said it was still too early to know about clinical effectiveness – which is why the pilot trial has gone ahead. “Once we are finished with this, we will have a sense of whether there is a clinical benefit,” she says. “What I will say is, my foremost query was whether people who had difficulty tolerating moderate to high compression would be able to tolerate this as an alternative. And I have been impressed at the level that they have been able to tolerate it.”
The current trial commenced in April and is scheduled for completion in December. If successful, researchers hope to conduct a much larger, national study.
One element hindering the uptake of electrical stimulation devices is cost, which ranges up to several thousand dollars per unit. Wound management expert Dr William McGuiness, head of school, Nursing and Midwifery at La Trobe, says that prices would have to drop before uptake would increase.
“[A more cost-effective price] would make electric stimulation therapy a very effective alternative,” he said. “Because a pair of stockings cost you between $50 and $60 and they last about six months – give or take. If you could buy something around, say, the $500 mark that’s going to keep edema down, then it’s feasible to look at that rather than buying stockings every six months.”
McGuiness has been wary of the use of technology in this space in the past, but he agrees that early signs are positive. “It is doing something to heal them and is also removing the fluid from their legs,” he says.
This type of research is important, he explains, especially as the population ages and some treatment options remain unsubsidised and adds that the whole range of chronic wounds is going to have to be addressed because of the significant strain they place on the healthcare dollar.
“As people get older we are still going to see more chronic wounds,” McGuiness says. “It is not just going to be venous ulcers, there will be more arterial ulcers, more neuropathic ulcers [due to the rise in diabetes] – and then there will be more pressure ulcers when they are admitted to residential aged care.”Do you have an idea for a story?
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