Back Pain Abhors a Vacuum:

Panko, Ron
Best’s Review- Life / Health, A.M. Best Company, Insurance Issues and Analysis, September 1998

A recent study says VAX-D therapy - disc decompression - should be considered a low-cost alternative to low-back sugery.

A study published in the April issue of Neurological Research, a peer-reviewed medical journal published in Wilton, Conn., considers vertebral axial decompression (VAX-D) therapy "a primary treatment modality" for low-back pain associated with lumbar disc herniation, degenerative disc disease and other low-back conditions.

"VAX-D by its unique design may more precisely address the physiology of persistent low-back pain than other conventional therapies;' wrote authors Earl E. Gose, William K. Naguszewski and Robert K. Naguszewski. Gose is a neurologist at the University of Illinois at Chicago, while the Naguszewskis are neurologists with Coosa Medical Group, Rome, Ga.

The findings could have implications for health plans, given the pervasiveness of low-back pain and the high costs of surgery. Subjects in the study reported increased low-back mobility and pain reduction following treatments, factors the authors said are important in workers'compensation.

VAX-D was developed in the 1970's and patented by Allan E. Dyer, M.D., Ph.D., the former Canadian Deputy Minister of Health, who also pioneered development of the heart defibrillator. It currently uses a protocol on a two-piece table that pulls the patient's injured disc back into place and takes pressure off the nerve roots.


FDA Approvals

VAX-D has won two approvals from the Food and Drug Administration, the first in 1989 for "providing a primary treatment modality for the management of pain and disability for patients presenting with incapacitating low-back pain." The second, in July 1996, said that VAX-D achieves those effects "through decompression of the intervertebral discs and facet joints, that is, unloading due to distraction and positioning." The FDA considers it a class II medical device, meaning that it is not experimental and has proven effectiveness.

So far, however, VAX-D has remained in the backwaters of health care. The American Medical Association's public relations office in New York, for example, could not find anything on the topic. The office of public affairs and communications at Kaiser Permanente, the giant Oakland, California-based managed care organization, could not find anyone in the company who had ever heard of it.

"Our view is that it's virtually unknown;" said Ross Brudenell, M.D., President of the National VAX-D Association, based in Anchorage, Alaska. "Only now is the traditional orthopedic community starting to pay some attention to the efficacy of this treatment."

Brudenell said VAX-D still faces two credibility problems. It was originally misinterpreted as another kind of traction, a discredited treatment, and the tables were originally marketed to chiropractors, not to orthopedic surgeons.



Vacuum in Disc Nucleus

According to the association, VAX-D dramatically decreases the amount of pressure on the spinal nerves by stretching or decompressing the patient's lower back, literally pulling the disc back into place and taking pressure off the nerve roots. Patients are placed into a harness that focuses the pressure on the lumbar portion of the back. While they lie on the two-part table, it slowly separates for one minute. In the next minute, the table parts come back together, reducing pressure and allowing the patient's back a rest phase. The process is repeated for 14 more cycles, and treatments last about 30 minutes.

"This periodic process allows patients to withstand stronger forces than can be tolerated when static techniques are used, and it promotes accommodation and relaxation during [the] therapy session," wrote the authors of the study.

VAX-D therapy creates a vacuum in the nucleus of the disc that realigns it. It also provides more space surrounding the disc, the study found. As a result of this vacuum, glucose, oxygen and other nutrients can enter the disc, "facilitating structural restoration of the disc and promoting disc rehydration," wrote the authors.

Comprehensive clinical studies have shown the treatment to be "extremely safe and effective," and extensive clinical experience has shown that a course of VAX-D therapy can eliminate the need for costly surgery. Brudenell says the simplest back operation costs more than $32,000, while VAX-D costs $3,500 – $5,500 for treatments over four to five weeks.

He adds that VAX-D patients' conditions are comparable to those that undergo back surgery. Those undergoing surgery will be out of work four to six weeks without active intervention by Workers' Compensation, but many VAX-D patients return to work before their treatment has ended. "The problem is they don't feel debilitated and feel too cocky," Brudenell said.

Brudenell said the Louisiana Workers' Compensation Board has recently accepted VAX-D at full price. "We're getting some favorable indication that in our region at least, the federal government will accept it, too," he said.


Know the Code

Medicare accepted VAX-D for a year but stopped because it does not have a code that comes close to describing the treatment. "Until we have a code that reliably and realistically reflects the treatment in this modality, we face an uphill battle," he said, adding the association has retained a consultant to help establish a code.

"The problem with this modality is that information is not getting to the level it needs to," said Ray Schalow, association treasurer. "The clerk types are getting the claims, then are sending letters out saying they don't know what it is."

About 200 medical facilities in the United States, Canada, Mexico and Australia currently offer VAX-D treatment. More than 70% of patients report significant improvement in their conditions.

The potential savings for health plans can also be significant. "The efficacy of this treatment is well-known enough now that it certainly deserves a place in the offerings that any plan gives to its subscribers, particularly because of the relative cost of treating disc disease surgically," said Brudenell. "We don't know today how many patients who have had surgery would have gotten well with VAX-D alone."

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