"Space Age technology cures back pain without surgery—86 percent success rate." Ads like this have been inundating my local newspaper. I wanted to know more. I am a medical doctor, and I wondered why my medical journals had neglected to tell me about this wonderful new discovery. I sent in for the free report.
I got the report, which was followed by repeat mailings, offers of free exams, postcards, and the offer of a free one-hour telephone seminar. I listened to the telephone conference along with (allegedly) 600 other people in my area. Now I know all about it, so I can share the information with you.
The report was from a chiropractor who provides "spinal decompression" treatments with a new computerized traction machine, the DRX 9000. This chiropractor was sure the machine worked, but he wasn't too sure what his own name was. He said he was Dan Baldwin, and his address and phone number were given correctly, but on page 6 of the report it said, "A consultation with me, Dr. Ben Altadonna. . . ."
I sent for another free report from another chiropractor's ad, and it cleared up the mystery. This almost identical report, from Dr. Frandanisa, had Dr. Frandanisa's name in the same spot on page 6. Apparently, the manufacturer provides a canned advertisement masquerading as a report for the individual chiropractor to send out under his own name, and Dr. Frandanisa took the time to read the instructions. I couldn't help but wonder if Dr. Baldwin was as careless in following the DRX 9000 treatment protocols as he was in reading the instructions in his advertising packet.
I learned from the report that NASA had discovered a cure for back pain. The absence of gravity in space relieved the pressure on spinal disks, relieved the bulge of disk herniation, and increased the height of astronauts. I didn't know NASA accepted astronauts with back pain, much less with bulging disks. I wondered what happens during liftoff and reentry, when the G-forces drastically increase the pressure on the disks. I searched the Internet and even contacted NASA but was unable to confirm the story.
I also learned that NASA uses surface electromyogram (EMG) testing to determine the cause of back pain. If NASA does, it should be ashamed of itself! Surface EMG is an unreliable, discredited test. Some chiropractors use it to hornswoggle their patients, but real doctors have declared it "unacceptable" for the diagnosis of low back pain or neuromuscular disorders (Pullman 2000).
Whether the NASA story was true or not, it seemed logical that relieving the pressure on a ruptured disk would relieve pain temporarily, but the claim was that it actually caused the disk to heal. Wouldn't that be nice? Unfortunately, it isn't true. This is an illegal claim, and such claims are disallowed in advertisements because they are not supported by scientific evidence. I guess if they disguise the advertisement as a "report" it doesn't count—freedom of speech and all that.
Disk disease is not a simple black-and-white diagnosis. Up to 40 percent of adults without back pain have herniated disks that show up on MRIs, so a positive MRI may or may not identify the cause of pain. There is a place for surgery in preventing permanent nerve damage, but too many operations are being done—often with poor results. Intensive rehabilitation may be preferable to surgery for many patients. Low back pain is a notoriously difficult problem to treat: an 86 percent success rate for any treatment would be phenomenal. I tried to track down the source of that claim. I read the references in the report and on the company's Web site, and the only real "evidence" boiled down to one single study (Gionis and Groteke 2003). It was not listed in PubMed; it was published in a throwaway publication that is provided free to doctors.
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.
The DRX 9000
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." Apart from the fact that this sentence is grammatically incoherent, it is obvious that they didn't know that the straight-leg-raising test is only positive for disk disease if radiating pain occurs above 30 degrees and below 60 degrees.
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.
From the ad, I learned that decompression has "no" side effects—except that it can make the pain worse and cause further disk damage! The authors admit that some patients discontinue therapy because of discomfort, and there is one report of sudden disk protrusion that occurred during treatment (Deen et al. 2003).
The manufacturers of the DRX 9000 claim that their machine is a uniquely effective product and is the only machine approved by the FDA for cervical decompression. This isn't exactly true. The DRX 9000 was given 501(k) approval by the FDA, which means that separate approval was not necessary because it was considered equivalent to a previously approved device. The previously approved device was the VAX-D, and there is nothing to show that the DRX 9000 is any more effective.
The Quackwatch Web site is a reliable source of information about questionable medical devices. Here's what it had to say about spinal decompression with the original VAX-D:
VAX-D is an expensive high-tech form of mechanical traction that can provide relief in some cases of back pain but is widely promoted with unsubstantiated claims that it can correct degenerated and herniated discs without surgery. When the FDA cleared [the] VAX-D table as a traction device, it set limits on what the manufacturer could claim. Individual providers, provider associations, and the manufacturer itself have exceeded these limits. VAX-D therapy may provide relief for properly selected patients. However, there are good reasons to believe that manual treatment can usually accomplish the same thing more quickly, safely, and less expensively. (Barrett N.d.)
The chiropractor made a big deal out of the patented technology that applies logarithmic forces with a bidirectional motor that can change seventeen times a second, but he couldn't prove that that would make any difference. They haven't even done any comparisons between the DRX 9000 and the VAX-D. You can get a patent for anything that is substantially different, whether it is effective or not. The fact that something is patented means zilch.
In the telephone seminar, he mentioned—in passing—that deconditioning and scoliosis both cause disk disease, which is news to medical science. He said that patients with disk disease have only three options: doing nothing, having surgery, or using his machine. What about chiropractic, epidural injections, physical therapy, pain pills, massage, etc.—aren't they options, too? Isn't it strange that a chiropractor doesn't consider chiropractic an option?
He talked about the cost without talking about the cost. He said it "varies," and insurance covers "part" of it. In reality, the cost is usually several thousand dollars, and insurance doesn't pay for anything except perhaps the original exam.
The chiropractor had patients call in with testimonials. One was very humorous. The caller had had pain only for three weeks, and tried decompression first because she "didn't want to get cut open or pay a lot of money." She thought she had a bulging disk because she could feel a bulge in her back! She rated her pain at 10 on a scale of 1–10—if I had maximum pain, I don't think I'd even be able to get to the chiropractor's office.
He used the old sales trick of time pressure—he said the first ten people to call from the telephone conference would get appointments, but he was too busy to see any more than that. If he's that busy, why is he advertising so aggressively?
He interviewed some potential patients/customers/victims/marks (take your choice). When one lady said she had had an epidural injection, he stressed that the relief from injections doesn't last. She started to say that hers had lasted for a long time. He didn't want to hear that, so he quickly interrupted to tell her (1) that her problem must have been mild; (2) that it was a blessing that her relief had lasted, since it didn't for other people; and (3) that he knew patients who had such severe pain from the injections that they would never do it again.
He also claimed, without giving supporting evidence, that the treatment "strengthened the ligaments." And he claimed that many diabetic patients think they have numbness in their feet from diabetic neuropathy when the real cause is unrecognized disk disease, and the numbness goes away after decompression treatments. This sounds screwy to me, because the pattern of numbness is very different in these two conditions, and it's unlikely a doctor would mistake one for the other.
He commiserated with one patient who was taking Oxycontin, saying that it can destroy your kidneys and liver. This simply isn't true—except maybe for IV drug abusers, or patients who already have kidney or liver disease.
Perhaps the funniest thing that this chiropractor admitted was that he started using the DRX 9000 because chiropractic wasn't working well for his patients. D.D. Palmer, who invented chiropractic, must be turning over in his grave: he claimed chiropractic could fix everything from soup to nuts. Recently some chiropractors in an online forum had a serious discussion about whether a person could obtain immortality if his spine were maintained in perfect alignment; opinions varied.
Baldwin kept asking, "Aren't you surprised that hospitals and orthopedic doctors don't use this treatment?" No, I'm not surprised at all. Other chiropractors are not impressed. Here's what one chiropractor, who will remain anonymous, had to say: "I find those that have undergone the decompression indicate that either (1) it was painful or (2) they felt better for about a month. The equipment is expensive, the protocol is for treatment five times a week for four weeks, and the charge is at least $250 a pop. The combination of expensive treatments and chiropractors is a lethal one."
I must admit that this "space age discovery" is a very effective decompression treatment: it decompresses the patient's wallet and does wonders for anemia of the chiropractic bank account!
My hat's off to these guys as salesmen. They are very good at what they do. Too bad it has nothing to do with real science or good medical care. I wouldn't buy a used car from these wheelers and dealers, much less trust them with my one and only spine. You can't believe everything you read in the newspaper.
Editor's Note: This article first appeared in Skeptical Inquirer magazine. Harriet Hall, also known as the SkepDoc, is a retired physician who lives in Puyallup, Washington, and writes about alternative medicine and pseudoscience. This is her fifth article for the Skeptical Inquirer. E-mail: harriet.hall (at ) comcast.net.
Associated Press. 2001. Incoming law review editor ousted. April 1. Available at: www.jwayne.com/news/archives/2001/20010406.shtml; accessed July 11, 2007.
Barrett, Stephen. N.d. Be wary of VAX-D therapy. Chirobase Web site. Available at: www.chirobase.org/06DD/vaxd/vaxd.html; accessed July 11, 2007.
Deen, H. Gordon Jr., Thomas D. Rizzo, and Douglas S. Fenton. 2003. Sudden progression of lumbar disk protrusion during vertebral axial decompression traction therapy. Mayo Clinic Proceedings 78: 1555–1556.
Elder, Nancy C., and Douglas R. Smucker. 2006. Back and Neck Pain. FP Essentials, Edition No. 322, AAFP Home Study. Leawood, Kansas: American Academy of Family Physicians, March.
Gionis, Thomas, and Eric Groteke. 2003. Spinal decompression, Orthopedic Technology Review, 6: 36–39.
Law editor ousted. 2001. The Milwaukee Journal Sentinel. April 2. Available at: http://findarticles.com/p/articles/mi_qn4196/is_20010402/ai_n1068678; accessed July 11, 2007.
Pullman, Seth L., Douglas S. Goodin, Anthony I. Marquinez, Samer Tabbal, and Michael Rubin. 2000. Clinical utility of surface EMG: Report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 55: 171–177.
Sherry, Eugene, Peter Kitchener, and Russell Smart. 2001. A prospective randomized controlled study of VAX-D and TENS for the treatment of chronic low back pain. Neurological Research 23: 780–784.