Many Norwegians live with chronic back pain. There may, for example, be consequences as a result of a prolapse. And even after several operations, the pain can persist. When surgery doesn’t work, there’s one type of treatment in particular that’s increasingly in demand: epidural spinal cord stimulation. The method has been available in Norway for over 40 years, but little research has been done on it. At least until now. In a new study from St. Olav’s hospital in Trondheim, researchers more or less establish that the expensive treatment does not work. – Considering how the treatment is increasing, both in Norway and internationally, many will probably be very surprised by the results. The study changes the rules of the game. Professor and neurosurgeon Sasha Gulati tells news. The study has been published in the renowned medical journal JAMA. Popular treatment Every year, more than 50,000 people in the world receive this pain treatment. In Norway, the figure is approximately 300. The method consists of a current-carrying wire stimulating the back of the spinal cord. The lead is connected to a battery, which is placed under the skin of the patient. 50 patients with pain after back surgery took part in the new study. All had surgery to insert a stimulator. The study took place over one year. During this time, patients had two rounds of stimulation. They also had two rounds of placebo (no stimulation). But none of them knew when and what was going on. Neither the patients nor the surgeons knew whether the stimulation was off or on. The answer only came when the analyzes were finished. This illustration will show how epidural spinal cord stimulation takes place. The treatment is not without risks, according to the researchers. Photo: Kari C. Toverud CMI Powerful placebo effect The results of the new study gave rather surprising answers. They showed that the pain, the quality of life and the patients’ activity level were the same both with and without stimulation. The study thus shows a strong placebo effect, the researchers write. – Our most important finding is that treatment with a spinal cord stimulator had no real effect in patients with persistent pain after previous back surgery, says Sasha Gulati. Sasha Gulati is a professor and surgeon at St. Olav’s hospital in Trondheim. Together with colleagues, he has carried out the new study. Photo: Ole Ekker Participants are surprised news has been in contact with one of the participants in the study. The man does not want to be named, but is surprised by the results. – It is surprising that the researchers do not find any differences, because I think this has helped me. But it is obviously difficult to say how big the effect has been. Nor should the placebo effect be overlooked, he says. Nevertheless, the person concerned emphasizes that other factors may also have helped him. – I have gotten better at handling the pain over time. You learn to live with it. I am also smarter in the choices I make. He adds that the right medication also has a lot to say. – The skepticism will increase Frode Kolstad is a specialist in neurosurgery and senior physician. He heads the Neurosurgery Department at Oslo University Hospital. Kolstad believes that the researchers in Trondheim have done an important job. And that the study is good. He says that although the treatment has been available in Norway for a long time, there have been large variations in the offer. The senior doctor believes the new study will have ripple effects, both in Norway and internationally. – This study has been published in a highly prestigious journal, and people will listen to the results. Articles that come in here are believed in. I think skepticism about this treatment will increase. He is not surprised by the results. Kolstad nevertheless specifies that this treatment can be useful for other types of injuries. But that it is then a question of major nerve damage following, for example, an accident or the like. Senior doctor Frode Kolstad believes the new study will lead to fewer people in Norway wanting to offer the treatment. Photo: Privat – Dumb or naughty Sasha Gulati and his colleagues were unsure of the effect of the treatment before they started the research. And perhaps with good reason. – The motivation for carrying out the study was a genuine doubt that this is a good treatment. We were concerned about the increasing use that is taking place. And that this happens in the absence of good documentation. – How can such treatment be introduced if the results are not sufficiently well documented? – When it comes to surgical treatments and implants, the requirement for documentation is significantly lower than that for new drugs. An approval by the FDA (Food and Drug Administration) in the USA often acts as a green light for use in normal clinical practice, says the professor. Gulati believes the study also shows how important it is to carry out research that is independent of industry. – This is an example of how doctors blindly trust the industry. To an extensive extent, expensive treatment is used without sufficient documentation. He is absolutely clear in his recommendation. – In my view, spinal cord stimulation should not be offered outside of well-planned clinical studies. If you just continue as before, you are either stupid or mean. news has tried to get in touch with one of the manufacturers behind the technology. The Norwegian spokesman has forwarded us to the American press department, where we are awaiting a response.
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A new study at St. Olav’s hospital shows that epidural spinal cord stimulation has no effect – news Trøndelag
