Pictured: Railgun patient launcher Magnetic resonance imaging machine

Pictured: Railgun patient launcher Magnetic resonance imaging machine, not a useful tool in identifying the cause of back pain

The ads in my local newspaper are a never-ending source of questionable health claims, most often from diet supplement manufacturers and chiropractors. There’s no single spokesman like Dr. Oz, but as a group they remind me of Oz’s unending series of weight loss miracles, each one the perfect solution until the next one comes along. The proliferation of chiropractic ads is bad advertising for the efficacy of chiropractic itself, since chiropractors are increasingly turning to adjunctive treatments like lasers and decompression machines.

The latest ad that annoyed me was from the Objective Diagnostics Research and Rehabilitation Institute (ODRRI). What an impressive name! On their website, not only do they advertise “the low back pain solution,” but they offer to fix herniated discs without surgery. They say they treat the underlying cause and say their approach is “based on solid and leading edge diagnostics, scientific research, and experience.” While not a complete lie, that statement is certainly misleading.

ODRRI: research institute or clinical practice?

Despite the impressive, sciencey title, the Objective Diagnostics Research and Rehabilitation Institute seems to consist of nothing more than two chiropractors promoting their business, Mark Woodham and Don Finlayson. Woodham owns an MRI and Motion X-ray company and has trademarked an exercise program.

Research

Under the “Research” tab, their website lists only two articles. They say:

We at ODRRI have published scientific research in peer-reviewed journals. We have recently published two articles supporting our treatment plan. We are the only group to show a reversal in low back muscle wasting and degeneration that is the underlying cause of instability in chronic recurrent low back pain.

Really? One of the two articles was published in PM&R, “The Role of the Lumbar Multifidus in Chronic Low Back Pain: A Review.” Another chiropractor, Michael Freeman, is the lead author. As the title indicates, it is a review of the current evidence for the role of multifidus muscle atrophy and the effect of stabilization exercises. It doesn’t even mention the specific techniques used by ODRRI.

The other article is a case series of three patients that was published in the Journal of Radiology Case Reports. It compares before-and-after MRIs of two patients who got spinal manipulative therapy plus low back exercises targeting the multifidus and one patient who got only spinal manipulation. The two that exercised had a decrease in multifidus atrophy and fatty replacement; the one who didn’t had an increase. The decrease in atrophy corresponded to functional improvements.

The article includes pictures of the MRIs. I was not trained to interpret MRIs, so I consulted an orthopedic surgeon and he consulted a radiologist friend of his, an expert who did a fellowship in musculoskeletal imaging. And the radiologist even got a second opinion from another radiologist. They agreed that “there is not much to these findings.” The radiologist was skeptical of the images for two reasons: “imaging is obtained with different units and not in identical scan plane” and “In the second case, there is decrease in fat throughout the field of view. i.e. compare subQ fat thickness.” They agreed that muscle atrophy is multifactorial and that decreased activity leads to muscle atrophy, but thought it was a bit of a stretch to assume that it correlates to the level of pain or is an indicator of therapeutic response. In addition, research suggests that there is little connection between symptoms and imaging findings of spinal degeneration or other abnormalities.

In short, ODRRI’s research does not constitute evidence that their hypothesis is correct or that their approach is effective.

Testimonials

Doctors who cure pneumonia with antibiotics or operate to remove inflamed appendixes don’t usually resort to advertising with testimonials from grateful patients. Quacks, snake oil salesmen, and purveyors of questionable treatments usually do. ODRRI offers testimonials, but only a paltry four of them. In one of them, a patient says Dr. Woodham told him that not only his back pain but his headaches, dizziness, and palpitations would also be relieved by spinal manipulation, specific exercises, and supplements; and they were. Another says, “At Dr. Woodham’s direction I also sleep on a strong magnetic pad that has helped my body recover…”

Magnetic mattress pads?!! That alone would be enough to make me question Dr. Woodham’s judgment. Here’s Quackwatch’s conclusion about magnet therapy:

There is no scientific basis to conclude that small, static magnets can relieve pain or influence the course of any disease. In fact, many of today’s products produce no significant magnetic field at or beneath the skin’s surface.

Blog

On their blog, they suggest that their methods may be triggering cellular regrowth. Maybe. They take credit for the MRI-verified resolution of a 7mm disc herniation. Since most herniated discs resolve on their own over time, even without treatment, there’s no way to know if this one resolved any faster because of their treatment. They like to do before-and-after MRIs on their patients to show what their treatments have accomplished, and apparently the results aren’t always this good, because they say, “Even when there is no change, that still tells us that what we did didn’t cause an effect, which could be a beneficial addition to the body of science for that particular type of approach.” Not really. The only real addition to the body of science would be a controlled study comparing their treatment to other treatments or no treatment.

The underlying cause of low back pain

Dr. Woodham had an epiphany. He hypothesized that the multifidus muscle (MFM), which controls (stabilizes) the neutral zone of spinal motion, needs to be stimulated or exercised within the neutral zone in order to reduce low back pain. After an injury, the MFM becomes “shut off,” atrophies, and is replaced by fat, making the spine unstable at that level. He says that without specific stimulation, the MFM will not begin working again.

The treatment

Their approach to treatment combines a number of modalities:

NZE: Perhaps the most important component is the trademarked Neutral Zone Exercise® (NZE) program. This is a set of core exercises developed by Dr. Woodham that he believes will selectively target the MFM and maximally stimulate it. He tested this hypothesis by trial-and-error experimenting on his patients without using a control group (that’s what he means by claiming it is “clinically proven”), and found that the exercises must be performed in a single plane of motion. He claims that proper performance of these exercises will create a pumping action to nourish the discs and cartilage and speed up tissue and cellular repair. He claims this is as effective as Salter’s continuous passive motion (CPM). If so, why does his clinic also offer CPM?

CPM: Continuous passive motion is used in rehabilitation after surgery or stroke, but there is only limited preliminary evidence for its effectiveness in low back pain. Aetna insurance considers it experimental and does not cover it.

Motion x-ray: This technique allows observation of the spine in motion, and can find abnormalities that are missed on regular x-rays. It is not a mainstream technology but is used almost exclusively by chiropractors. It exposes the patient to considerably more radiation than a single x-ray, and was banned by Health Canada because of unknowns about energy output and calibration status. Aetna classifies it as experimental and investigational and does not cover it.

Pulsed Electromagnetic Field Therapy (PEMF): They admit that PEMF is not widely used in the US. It was allegedly developed by the Soviet space program “due to their cosmonauts experiencing negative effects following reduced magnetic exposure during spaceflight.” (I suspect the negative effects were mainly due to lower gravity, not lower magnetic field strength.) PEMF is an FDA-approved treatment for stimulating bone growth in non-union of fractures. It has also been used by plastic surgeons to manage postoperative pain and edema, to treat chronic wounds, and to facilitate vasodilation and angiogenesis.

There is no evidence that it improves outcomes in low back pain. In fact, after reviewing all the evidence, Aetna determined that its effectiveness had not been established for most uses.

Spinal decompression therapy: They claim that this is 70-80% effective. I have already looked into the claims for spinal decompression machines and found them wanting. The Medical Letter concluded:

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.

Lifestyle changes: OK, that sounds like a good idea in general, especially for patients who are overweight or have nutritional deficiencies. I don’t know about the unspecified “dietary toxins” they refer to.

Nutrition: They have “put together a solid foundation of healthy diet choices” and “joint supplementation will be at the core of your nutritional supplement program.” They don’t offer any evidence that diet changes or supplements can improve the outcome of back pain.

NOTE: when I cite Aetna, I am not citing them as an authority, but only as one example of a group that has reached a different conclusion after reviewing the existing scientific literature. In other words, if Aetna considers a treatment or diagnostic method experimental, that indicates to me that the method is not generally accepted as a conventional mainstream method, has not been proven to everyone’s satisfaction, and remains questionable.

Conclusion

There is no way to know if ODRRI’s multifidus muscle hypothesis is correct. There is no way to know if their approach is really successful in treating back pain. There is no way to know if it is superior to other approaches, since no controlled studies have been done. The natural history of low back pain is that it usually resolves over time with or without treatment. We know that bed rest slows recovery and that exercise, even just walking, aids recovery. So without a proper control group, ODRRI’s research is practically guaranteed to confirm their beliefs. They may be good marketers, but they are not good scientists.

I can believe their exercise program will help back pain patients, but I’m not persuaded that any other good exercise program wouldn’t help just as much, and I’m very skeptical about most of the other things they offer. I would love to believe they have found “the back pain solution,” but I will remain unconvinced until they can provide more credible data.

 

 

Posted by Harriet Hall

Harriet Hall, MD also known as The SkepDoc, is a retired family physician who writes about pseudoscience and questionable medical practices. She received her BA and MD from the University of Washington, did her internship in the Air Force (the second female ever to do so),  and was the first female graduate of the Air Force family practice residency at Eglin Air Force Base. During a long career as an Air Force physician, she held various positions from flight surgeon to DBMS (Director of Base Medical Services) and did everything from delivering babies to taking the controls of a B-52. She retired with the rank of Colonel.  In 2008 she published her memoirs, Women Aren't Supposed to Fly.