Evidence doesn’t support spinal cord stimulators for chronic back pain – and they could cause harm

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In an episode of ABC’s Four Corners this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

What does the evidence say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

What about the harms?

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”.

We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

A man lying on a bed with a hand on his lower back.
Chronic back pain can be debilitating. CGN089/Shutterstock

High costs

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000. With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

It’s not all bad news

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, Professor of Orthopaedic Surgery, UNSW Sydney; Adrian C Traeger, Research Fellow, Institute for Musculoskeletal Health, University of Sydney, and Caitlin Jones, Postdoctoral Research Associate in Musculoskeletal Health, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Sun-Dried Tomatoes vs Carrots – Which is Healthier?

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Our Verdict

    When comparing sun-dried tomatoes to carrots, we picked the sun-dried tomatoes.

    Why?

    After tomatoes lost to carrots yesterday, it turns out that sun-drying them is enough to turn the nutritional tables!

    This time, it’s the sun-dried tomatoes that have more carbs and fiber, as well as the nominally lower glycemic index (although obviously, carrots are also just fine in this regard; nobody is getting metabolic disease from eating carrots). Still, by the numbers, a win for sun-dried tomatoes.

    In terms of vitamins, the fact that they have less water-weight means that proportionally, gram for gram, sun-dried tomatoes have more of vitamins B1, B2, B3, B5, B6, B9, C, E, K, and choline, while carrots still have more vitamin A. An easy win for sun-dried tomatoes on the whole, though.

    When it comes to minerals, sun-dried tomatoes have more calcium, copper, iron, magnesium, manganese, phosphorus, potassium, selenium, and zinc, while carrots are not higher in any mineral.

    Looking at polyphenols, sun-dried tomatoes have more, including a good healthy dose of quercetin; they also have more lycopene, not technically a polyphenol by virtue of its chemical structure (it’s a carotenoid), but a powerful phytochemical nonetheless. And, the lycopene content is higher in sun-dried tomatoes (compared to raw tomatoes) not just because of the loss of water-weight making a proportional difference, but also because the process itself improves the lycopene content, much like cooking does.

    All in all, a clear and overwhelming win for sun-dried tomatoes.

    Just watch out, as this is about the sun-dried tomatoes themselves; if you get them packed in vegetable oil, as is common, it’ll be a very different nutritional profile!

    Want to learn more?

    You might like to read:

    Tomatoes vs Carrots – Which is Healthier? ← see the difference!

    Enjoy!

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  • Constipation increases your risk of a heart attack, new study finds – and not just on the toilet

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    If you Google the terms “constipation” and “heart attack” it’s not long before the name Elvis Presley crops up. Elvis had a longstanding history of chronic constipation and it’s believed he was straining very hard to poo, which then led to a fatal heart attack.

    We don’t know what really happened to the so-called King of Rock “n” Roll back in 1977. There were likely several contributing factors to his death, and this theory is one of many.

    But after this famous case researchers took a strong interest in the link between constipation and the risk of a heart attack.

    This includes a recent study led by Australian researchers involving data from thousands of people.

    Elvis Presley was said to have died of a heart attack while straining on the toilet. But is that true? Kraft74/Shutterstock

    Are constipation and heart attacks linked?

    Large population studies show constipation is linked to an increased risk of heart attacks.

    For example, an Australian study involved more than 540,000 people over 60 in hospital for a range of conditions. It found constipated patients had a higher risk of high blood pressure, heart attacks and strokes compared to non-constipated patients of the same age.

    A Danish study of more than 900,000 people from hospitals and hospital outpatient clinics also found that people who were constipated had an increased risk of heart attacks and strokes.

    It was unclear, however, if this relationship between constipation and an increased risk of heart attacks and strokes would hold true for healthy people outside hospital.

    These Australian and Danish studies also did not factor in the effects of drugs used to treat high blood pressure (hypertension), which can make you constipated.

    Man sitting on toilet, clutching tummy with one hand, holding toilet roll in other
    Researchers have studied thousands of people to see if there’s a link between constipation and heart attacks. fongbeerredhot/Shutterstock

    How about this new study?

    The recent international study led by Monash University researchers found a connection between constipation and an increased risk of heart attacks, strokes and heart failure in a general population.

    The researchers analysed data from the UK Biobank, a database of health-related information from about half a million people in the United Kingdom.

    The researchers identified more than 23,000 cases of constipation and accounted for the effect of drugs to treat high blood pressure, which can lead to constipation.

    People with constipation (identified through medical records or via a questionnaire) were twice as likely to have a heart attack, stroke or heart failure as those without constipation.

    The researchers found a strong link between high blood pressure and constipation. Individuals with hypertension who were also constipated had a 34% increased risk of a major heart event compared to those with just hypertension.

    The study only looked at the data from people of European ancestry. However, there is good reason to believe the link between constipation and heart attacks applies to other populations.

    A Japanese study looked at more than 45,000 men and women in the general population. It found people passing a bowel motion once every two to three days had a higher risk of dying from heart disease compared with ones who passed at least one bowel motion a day.

    How might constipation cause a heart attack?

    Chronic constipation can lead to straining when passing a stool. This can result in laboured breathing and can lead to a rise in blood pressure.

    In one Japanese study including ten elderly people, blood pressure was high just before passing a bowel motion and continued to rise during the bowel motion. This increase in blood pressure lasted for an hour afterwards, a pattern not seen in younger Japanese people.

    One theory is that older people have stiffer blood vessels due to atherosclerosis (thickening or hardening of the arteries caused by a build-up of plaque) and other age-related changes. So their high blood pressure can persist for some time after straining. But the blood pressure of younger people returns quickly to normal as they have more elastic blood vessels.

    As blood pressure rises, the risk of heart disease increases. The risk of developing heart disease doubles when systolic blood pressure (the top number in your blood pressure reading) rises permanently by 20 mmHg (millimetres of mercury, a standard measure of blood pressure).

    The systolic blood pressure rise with straining in passing a stool has been reported to be as high as 70 mmHg. This rise is only temporary but with persistent straining in chronic constipation this could lead to an increased risk of heart attacks.

    Doctor wearing white coat checking patient's blood pressure
    High blood pressure from straining on the toilet can last after pooing, especially in older people. Andrey_Popov/Shutterstock

    Some people with chronic constipation may have an impaired function of their vagus nerve, which controls various bodily functions, including digestion, heart rate and breathing.

    This impaired function can result in abnormalities of heart rate and over-activation of the flight-fight response. This can, in turn, lead to elevated blood pressure.

    Another intriguing avenue of research examines the imbalance in gut bacteria in people with constipation.

    This imbalance, known as dysbiosis, can result in microbes and other substances leaking through the gut barrier into the bloodstream and triggering an immune response. This, in turn, can lead to low-grade inflammation in the blood circulation and arteries becoming stiffer, increasing the risk of a heart attack.

    This latest study also explored genetic links between constipation and heart disease. The researchers found shared genetic factors that underlie both constipation and heart disease.

    What can we do about this?

    Constipation affects around 19% of the global population aged 60 and older. So there is a substantial portion of the population at an increased risk of heart disease due to their bowel health.

    Managing chronic constipation through dietary changes (particularly increased dietary fibre), increased physical activity, ensuring adequate hydration and using medications, if necessary, are all important ways to help improve bowel function and reduce the risk of heart disease.

    Vincent Ho, Associate Professor and clinical academic gastroenterologist, Western Sydney University

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • The Best Exercise to Stop Your Legs From Giving Out

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    Dr. Doug Weiss, seniors-specialist physio, has an exercise that stops your knees from being tricked into collapsing (which is very common) by a misfiring (also common) reflex.

    Step up…

     Setup to step up thus:

    •         Use a sturdy support like a countertop or chair.
    •         Have an aerobic step or similar firm surface to step onto.

       When you’re ready:

    •         Stand facing away from the step.
    •         Place one hand on the support for stability.
    •         Step backwards up onto the step with your right leg, then your left leg, so both feet are on the step.
    •         Step forward to come back down.

    Once you’re confident of the series of movements, do it without the support, and do it for a few minutes each day. Don’t worry about how easy it becomes; this is not, first and foremost, a strength-training exercise; you don’t have to start adding weights or anything (although of course you can if you want).

    How it works: there’s a part of you called the Golgi tendon organ, and it can trigger a Golgi tendon reflex, which is one of the body’s equivalents of a steam valve. However, instead of letting off steam to avoid a boiler explosion, it collapses a joint to save it from overload. However, if not exercised regularly, it can get overly sensitive, causing it to mistake your mere bodyweight for an overload. So, it collapses, thinking it is saving you from snapping a tendon, but it’s not. By exercising in the way described, the Golgi tendon reflex will go back to only being triggered by an actual overload, not the mere act of stepping.

    Writer’s note: this one’s interesting to me as I have a) a strong lower body b) hypermobile joints that thus occasionally just fold like laundry regardless. Could it be that this will fix that? I guess I’ll find out 🙂

    Meanwhile, for more on all of the above plus a visual demonstration, enjoy:

    Click Here If The Embedded Video Doesn’t Load Automatically!

    Want to learn more?

    You might also like:

    What Nobody Teaches You About Strengthening Your Knees

    Take care!

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  • Tuna vs Catfish – Which is Healthier?

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Our Verdict

    When comparing tuna to catfish, we picked the tuna.

    Why?

    Today in “that which is more expensive and/or harder to get is not necessarily healthier”…

    Looking at their macros, tuna has more protein and less fat (and overall, less saturated fat, and also less cholesterol).

    In the category of vitamins, both are good but tuna distinguishes itself: tuna has more of vitamins A, B1, B2, B3, B6, and D, while catfish has more of vitamins B5, B9, B12, E, and K. They are both approximately equal in choline, and as an extra note in tuna’s favor (already winning 6:5), tuna is a very good source of vitamin D, while catfish barely contains any. All in all: a moderate, but convincing, win for tuna.

    When it comes to minerals, things are clearer still: tuna has more copper, iron, magnesium, phosphorus, potassium, and selenium, while catfish has more calcium, manganese, and zinc. Oh, and catfish is also higher in one other mineral: sodium, which most people in industrialized countries need less of, on average. So, a 6:3 win for tuna, before we even take into account the sodium content (which makes the win for tuna even stronger).

    In short: tuna wins the day in every category!

    Want to learn more?

    You might like to read:

    Farmed Fish vs Wild Caught (It Makes Quite A Difference)

    Take care!

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  • The Sweet Truth About Glycine

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Make Your Collagen Work Better

    This is Dr. James Nicolantonio. He’s a doctor of pharmacy, and a research scientist. He has a passion for evidence-based nutrition, and has written numerous books on the subject.

    Controversy! Dr. DiNicolatonio’s work has included cardiovascular research, in which field he has made the case for increasing (rather than decreasing) the recommended amount of salt in our diet. This, of course, goes very much against the popular status quo.

    We haven’t reviewed that research so we won’t comment on it here, but we thought it worth a mention as a point of interest. We’ll investigate his claims in that regard another time, though!

    Today, however, we’ll be looking at his incisive, yet not controversial, work pertaining to collagen and glycine.

    A quick recap on collagen

    We’ve written about collagen before, and its importance for maintaining… Well, pretty much most of our body, really, buta deficiency in collagen can particularly weaken bones and joints.

    On a more surface level, collagen’s also important for healthy elastic skin, and many people take it for that reason alone,

    Since collagen is found only in animals, even collagen supplements are animal-based (often marine collagen or bovine collagen). However, if we don’t want to consume those, we can (like most animals) synthesize it ourselves from the relevant amino acids, which we can get from plants (and also laboratories, in some cases).

    You can read our previous article about this, here:

    We Are Such Stuff As Fish Are Made Of

    What does he want us to know about collagen?

    We’ll save time and space here: first, he’d like us to know the same as what we said in our article above

    However, there is also more:

    Let’s assume that your body has collagen to process. You either consumed it, or your body has synthesized it. We’ll skip describing the many steps of collagen synthesis, fascinating as that is, and get to the point:

    When our body weaves together collagen fibrils out of the (triple-helical) collagen molecules…

    • the cross-linking of the collagen requires lysyl oxidase
    • the lysyl oxidase (which we make inside us) deanimates some other amino acids yielding aldehydes that allow the stable cross-links important for the high tensile strength of collagen, but to do that, it requires copper
    • in order to use the copper it needs to be in its reduced cuprous form and that requires vitamin C
    • but moving it around the body requires vitamin A

    So in other words: if you are taking (or synthesizing) collagen, you also need copper and vitamins A and C.

    However! Just to make things harder, if you take copper and vitamin C together, it’ll reduce the copper too soon in the wrong place.

    Dr. DiNicolantonio therefore advises taking vitamin C after copper, with a 75 minutes gap between them.

    What does he want us to know about glycine?

    Glycine is one of the amino acids that makes up collagen. Specifically, it makes up every third amino acid in collagen, and even more specifically, it’s also the rate-limiting factor in the formation of glutathione, which is a potent endogenous (i.e., we make it inside us) antioxidant that works hard to fight inflammation inside the body.

    What this means: if your joints are prone to inflammation, being glycine-deficient means a double-whammy of woe.

    As well as being one of the amino acids most key to collagen production, glycine has another collagen-related role:

    First, the problem: as we age, glycated collagen accumulates in the skin and cartilage (that’s bad; there is supposed to be collagen there, but not glycated).

    More on glycation and what it is and why it is so bad:

    Are You Eating Advanced Glycation End-Products? The Trouble Of The AGEs

    Now, the solution: glycine suppresses advanced glycation end products, including the glycation of collagen.

    See for example:

    Glycine Suppresses AGE/RAGE Signaling Pathway and Subsequent Oxidative Stress by Restoring Glo1 Function

    With these three important functions of glycine in mind…

    Dr. DiNicolantonio therefore advises getting glycine at a dose of 100mg/kg/day. So, if you’re the same size as this rather medium-sized writer, that means 7.2g/day.

    Where can I get it?

    Glycine is found in many foods, including gelatin for those who eat that, eggs for the vegetarians, and spinach for vegans.

    However, if you’d like to simply take it as a supplement, here’s an example product on Amazon

    (the above product is not clear whether it’s animal-derived or not, so if that’s important to you, shop around. This writer got some locally that is certified vegan, but is in Europe rather than N. America, which won’t help most of our subscribers)

    Note: pure glycine is a white crystalline powder that has the same sweetness as glucose. Indeed, that is how it got its name, from the Greek “γλυκύς”, pronounced /ɡly.kýs/, meaning “sweet”. Yes, same etymology as glucose.

    So don’t worry that you’ve been conned if you order it and think “this is sugar!”; it just looks and tastes the same.

    That does mean you should buy from a reputable source though, as a con would be very easy!

    this does also mean that if you like a little sugar/sweetener in your tea or coffee, glycine can be used as a healthy substitute.

    If you don’t like sweet tastes, then, condolences. This writer pours two espresso coffees (love this decaffeinated coffee that actually tastes good), puts the glycine in the first, and then uses the second to get rid of the sweet taste of the first. So that’s one way to do it.

    Enjoy (if you can!)

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  • Hazelnuts vs Pistachios – Which is Healthier?

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    Our Verdict

    When comparing hazelnuts to pistachios, we picked the hazelnuts.

    Why?

    An argument could be made for either, depending on what we prioritize! So there was really no wrong answer here today, but it is good to know what each nut’s strengths are:

    In terms of macros, pistachios have more fiber, carbs, protein, and (mostly healthy) fat. That does make them the “more food per food” option, but it’s worth noting that while hazelnuts have more fiber, they also have a higher margin of difference when it comes to their greater carb count, and resultantly, hazelnuts do have the lower glycemic index. That said, they’re still both low-GI foods, so we’ll call this section a win for pistachios overall.

    When it comes to vitamins, hazelnuts have more of vitamins B3, B5, B9, C, E, K, and choline, while pistachios have more of vitamins A, B1, B2, and B6. So, a fair 7:4 win for hazelnuts here.

    In the category of minerals, hazelnuts have more calcium, copper, iron, magnesium, manganese, and zinc, while pistachios have more phosphorus, potassium, and selenium. A clear 6:3 win for hazelnuts.

    In short, both are good sources of many nutrients, so choose according to what you want to prioritize, or better yet, enjoy both.

    Want to learn more?

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    Why You Should Diversify Your Nuts

    Take care!

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