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Misleading Ads for Back Pain Treatment

There was a full-page ad in my local paper today for Back in Action Spine and Health Centers, targeted at sufferers from almost any kind of chronic back pain. It started with “Are You Ready to Throw in the Towel and Just Live with Hurting So Bad?” It went on to make a number of claims:

  • Doctors can fix the problem.
  • Breakthrough medical technologies.
  • Treatments are FDA cleared.
  • Treatments are scientifically proven.
  • No side effects.
  • Best kept secrets for healing “bad backs.”
  • Corrects scoliosis.
  • Corrects compressed discs.
  • Several university studies at Johns Hopkins, Stanford and Duke have confirmed that these treatments work.
  • Medical researchers have reported these methods up to 89% effective.
  • Treatments work for back and neck pain, sciatica/numbness, herniated and/or bulging discs, degenerative disc disease (arthritis), spinal stenosis, facet syndromes, spondylolisthesis.
  • Their questionnaire can determine who will benefit – if you fit even one criterion like “does your back feel out of alignment?” or “do you have arthritis?” you should call right away.

The ad offers a “Free Qualifying Exam” but you “Must Not Wait” because appointments are limited and they can only honor this free offer for 3 weeks. To encourage you to call, they sweeten the pot with a FREE $49 gift bag.

Are you suspicious yet? You should be.

All the claims listed above are false. Ads like this are promoting a machine that promises nonsurgical spinal decompression (the DRX 9000 or a related device). These machines are not a breakthrough of any kind; they’re just a fancy technological gimmick for providing old-fashioned traction. The same traction that has been rejected by mainstream medicine because it does nothing to change the outcome and seldom even does anything to temporarily relieve symptoms. The FDA approval is a “grandfathered” 510(k) clearance that only says the new device is equivalent to older traction devices so it doesn’t require separate approval. The “doctors” are almost always chiropractors, and not identifying themselves as chiropractors is a direct violation of their own published ethics guidelines. Claims for effectiveness are based on junk science: case reports and uncontrolled, poor quality pilot studies usually funded by the manufacturer. There is NO acceptable evidence that these machines are effective, and a recent review article in the chiropractors’ own literature says as much. These treatments DO have side effects; they sometimes aggravate symptoms and can harm patients. They cannot “correct” ruptured discs and the FTC does not allow them to claim that they can.

Insurance and Medicare do not cover these treatments, and they usually end up costing the patient several thousand dollars out of pocket. They may provide temporary relief for a minority of patients, but the same results could be obtained far more cheaply by a physical therapist whose treatments are covered by insurance.

I’ve written about these machines before. An article I wrote in Skeptical Inquirer is available online at http://findarticles.com/p/articles/mi_m2843/is_5_31/ai_n27361167  It covers more details than I can include here. Some of what I found would be laugh-out-loud funny except that people are being misled, relieved of their money, and even physically harmed (there is at least one report that the machine caused a ruptured disc). For those who may not want to read that whole article, here’s an excerpt highlighting their inept advertising techniques and the abysmal quality of their evidence:

The report did not even give the correct reference for this essential study. It listed one of the two authors with all his titles (MD, JD, MBA, FICS, FRCS), misprinted one of his titles (“FICA” instead of FICS), omitted the name of the second author, gave the name of the journal incorrectly, misquoted the title of the article, and misprinted spinal as spinla. Another reference consisted of nothing but the name of a journal. The report was full of spelling errors, used loose for lose and included lexical gems like “it depends on your individually case.” A mistake or two in an individual doctor’s report would be excusable, but this report was prepared by a company with a product to sell. If carelessness about English and the facts extends to carelessness in manufacturing its machines, it may have a few loose screws–and not just in the machines.

Despite the faulty citation, I was able to find the study that the 86-percent claim was based on. It was easy to see why it wasn’t published in a reputable, peer-reviewed medical journal–it wouldn’t have passed review. There are so many things wrong with it that it can more rightly serve as an example of a bad study. A good study randomizes patients into treatment and control groups. This study had no control group, and its only randomization was that 229 subjects were “randomly” chosen from a pool of 500 with disk disease. The point of this escapes me. Part of the exam was a straight-leg-raising test: “… radiating pain into the lower back and leg was categorized when raising the leg over 30 degrees or less is considered positive, but if pain remained isolated in the lower back, it was considered negative.” [no, this doesn’t make sense, either grammatically or medically]…

Next I read that “Each session consisted of a 45-minute treatment on the equipment followed by 15 minutes of ice and interferential frequency therapy to consolidate the lumbar paravertebral muscles.” Sorry, but I don’t have any idea what it means to “consolidate” a muscle, and the “interferential frequency therapy” seems to be a kind of TENS (Transcutaneous Electrical Nerve Stimulation). TENS was shown to have zero effectiveness in another study (Sherry et al. 2001) cited by decompression advocates, so I fail to see why they used it here. The patients also were instructed to wear lumbar support belts, restrict activity, and take nonsteroidal drugs. You don’t suppose that any of those factors could have helped relieve their pain, do you? And how many of these patients might have had resolution of their symptoms without any treatment? The natural history of disk disease is that “The herniated portion of the disk visible on serial MRI studies tends to heal and regress with time. Partial or complete resolution of the herniated portion of the disk over 6 months may occur in as many as two thirds of patients” (Elder and Smucker 2006). And I don’t see how it can be claimed that this study supports using the DRX 9000, because nowhere in the study does it say what machine was used. I e-mailed the company and asked if they could verify that this was its machine. There was no reply.

I tried to track down the primary author of the study, Thomas Gionis. He has no studies on back pain listed in PubMed. He apparently has left medicine for law and was recently removed from his position as editor of a law review because he spent thirty months in jail on a felony assault conviction for hiring someone to beat up his ex-wife, the daughter of John Wayne, because of a custody dispute (“Law editor” 2001). In addition, he had lost his medical license and was trying to get it reinstated (Associated Press 2001). Somehow he does not inspire confidence as a medical authority.

On June 2, 2008, The Medical Letter evaluated spinal decompression machines, concluding:

There is no acceptable evidence that non-surgical spinal decompression machines can correct degenerated or herniated discs or that they relieve pain in patients with these conditions. There is also no convincing evidence that the physiological responses of lumbar tissue to power traction equipment are superior to those with standard mechanical traction.

After I wrote the Skeptical Inquirer article, I received e-mails from disappointed patients, from neurosurgeons and even from chiropractors, thanking me for exposing this scam. One of the chiropractors came right out and called the spinal decompression claims “lies” and said:

I can tell you exactly why they became such instant hits with the chiropractic community. Money. Within 6 months of the first time I had heard of a DRX 9000 I started seeing testimonials by chiropractors, in publications for chiropractors, touting the fact that they are clearing an additional $50,000 per month with this. Who doesn’t like the thought of an extra $600,000 income each year?

The manufacturers of the DRX 9000 are under siege: the FDA raided their headquarters and they’ve been sued and accused of false advertising, of injuring patients, and of instructing DRX 9000 clinic owners how to defraud insurance companies by submitting false billing codes. Perhaps this new, more veiled ad campaign is an attempt at damage control. For one thing, they’ve removed the claim that the machine is a “space age discovery” resulting from NASA research on astronauts (that was a total fabrication).

It is ironic that these machines are being used by chiropractors. Chiropractors, the self-proclaimed back experts, the ones who claim their adjustments are the answer to everything that ails you or at least to most musculoskeletal problems. Using these machines amounts to a confession that chiropractic adjustments are not so effective after all.

Posted in: Chiropractic, Health Fraud

Leave a Comment (8) ↓

8 thoughts on “Misleading Ads for Back Pain Treatment

  1. sjames1958 says:

    Is this similar to the guy who has ads selling, what is basically an inversion table. I have been wondering what the medical efficacy of that device is.

    S

  2. flyfishdan says:

    This is a very accurate and informative article. I do independent medical evaluation work in this area and run across abuse of this device by chiropractors many of whom will add massage (by their own therapist), adjustments, electrical stimuation, hot or cold packs, and traction often all on the same day and frequently 3 times a week for months. They do this mostly with auto-accidents where insurance is more likely to pay and for which a bill in excess of 10K is not unusual for a problem that might otherwise be self-limiting.

  3. chillerguy says:

    I’m with sjames, I want to know is effect similar to the inversion tables I’ve seen advertised on TV? They seem kind of hoakey and I’ve always been skeptical about them.

  4. I’m sure it’s just a matter of time before some disgruntled customer sues the misleading advertisers out of business.

  5. Harriet Hall says:

    Inversion tables are a way of providing traction by simple gravity. At best they might offer temporary relief to selected patients. Websites like http://www.losethebackpain.com/inversion3.html make other ridiculous claims.

    Yes, individual companies will eventually go out of business, but only after substantial profits have been made. And as soon as one company goes out of business another will take its place.

  6. chillerguy says:

    Thanks for the reply Harriet!

  7. Miss_Kitt says:

    Nice article, and I like the new site, Dr. Harriet!

    As a woman of mature years who suffers from occasional backpain, I have to say that–for some kinds of back pain–light traction can help ease the pain. However, I’ve never used it without also using light exercise, anti-inflams, and cold against the sore spot, so I can’t vouch for its effectiveness alone.

    My particular issue is due to an accumulation of stuff that culminates every few months in a fair bit of pain and stiffness which, if left untreated, leads to back spasms. Having seen a wonderful PT, an MD, and a podiatrist (at least part of this is due to my walk having changed due to broken bones in my foot), I have tried a variety of treatments; and *for me*, part of the solution is traction. The PT did something wonderful involving a strap, a position that looks faintly pornographic, and pulling out on hips for about 4 minutes. I don’t understand how it works, unless it’s just getting certain muscles to not be under strain and unkink–but I get very similar results from strategic use of the lower end of a climbing gym in the local elementary school playground. Sometimes hanging from my knees (not all my weight) for a few minutes gets everything back in working order.

    I have reluctantly accepted that my back getting sore after I drive for more than 3 hours, stand for more than 2 hours, or sit at my desk for more than 3 hours is just going to be part of my life for now. The best I have been able to do is try to build breaks to stretch, move, and change position into my routine–and accept that the first night after a plane flight is going to be tough.

    I’m not surprised that people are desperate to find some magic cure–when my back was spasming, I was literally disabled. But I went to the boring medical doctor, took her advice (and my muscle relaxants) and got back into been functional in short order. The longer-term fix is not perfect, but so much better that I have hope that a year or so may lead to full recovery.

    Perhaps something that medical educators need to teach the public is that sometimes there isn’t a quick fix–especially if you’re over 40. Here in the land of fast food, fast cars, and fast forwarding through the recorded ads, people expect bodies to heal in 2 days to a week.

    Just my thoughts, Miss Kitt

  8. scotsilv says:

    As former medical programs manager / workers comp case handler at a large municipal transit authority, I was faced daily with an organized network of chiropractors, physician “injury centers” (a.k.a. hot pack/lumbar xray mills) and on-the-take lawyers. It was stunning to watch in action, and difficult to challenge in the leftist/militant labor union environment of a big city.

    Typical scenario:

    2,500-lb car rear ends 30,000-lb bus (net weight, excluding passengers!) at around 5 MPH. Minor dents to both.

    Somehow, the massive acceleration/deceleration and the forces of impact mysteriously travel up transmission of bus, take a vertical leap into the air spring cushioned driver’s seat, and end up in the driver’s spine.

    Chiropractor and/or injury clinic doc gives diagnosis of “acute lumbosacral strain and sprain, myofasciitis” etc. and declares driver unfit for duty and requiring months of “treatment” at their “clinic.” After, of course, this is preceded by a round or two of lumbar x-rays (radiation be damned – these were young people in general), CT scans, MRI’s etc. and followup x-rays at regular intervals looking for “subluxation.” God forbid the “bulging disc” on MRI, which most people have asymptomatically.

    The diagnosis of “bulging disc” was akin to “hitting the jackpot”, worker’s comp-wise.

    On exam, the patient would typically exhibit the signs of what I used to term “no objective signs or symptoms to substantiate complaints, and multiple inconsistencies on exam.”

    Notably, the “workers comp wriggle” (massive exaggerated movement on light touching of lumbar spine with fingertip), lack of pain while sitting when I extended their calves horizontal to help put on their shoes, but massive pain on 45 degree leg rise while supine, back pain when pressing down on their head while standing, and the like.

    The chiropractors and injury docs mysteriouly never had such findings.

    On the other hand, one injury doc’s “muscle knots” in a mid 20′s driver who had been under his treatment for a few months was to my exam a far more serious problem: rip roaring diffuse lymphadenopathy, with epitrochlear and even radial fossa nodes of Medical Student size, indicative of – among other things – lymphatic malignancy.

    And these guys would win at arbitration (AAA) when we challenged the b.s.

    One wonders why worker’s comp is such a financial strain to companies.

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