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CONTROVERSY SPARKED BY REPORTS OF SUCCESSFUL PHYSICAL THERAPY FOR DISCDISEASE PAIN IN UNCONTROLLED TRIAL

Schuster, Larry

Original Article

MIAMI BEACH—Neurologists and patients alike might well be intrigued by a non-invasive therapy for spinal disc disease, a common ailment affecting an estimated 65 million people in the US annually.

So the report of a new physical therapy technique that proved effective for treating severe pain due to disc disease drew a packed room at the AAN Annual Meeting here in April.

But while the results as presented seemed promising, experts, who were not involved with the study, questioned the validity of the findings without any controls for comparison. Moreover, they said longer and larger clinical trials would need to be conducted to verify the findings.

Conrado Estol, MD, PhD, of the Neurologic Center for Treatment and Rehabilitation in Buenos Aires, Argentina, said the technique, Souchard's Global Postural Re-education (GPR), reduced or eliminated pain where months of a variety of other approaches failed.

Dr. Estol presented results of a study of 102 patients who had persistent pain for at least six months. They all had been treated prospectively from 2000 to 2004.

In the uncontrolled study, 85 percent had improved after three weeks of treatment, and their pain had not recurred for an average of nearly two years.

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THERAPY WIDELY USED IN EUROPE

Dr. Estol said the method involves stretching and strengthening the entire tonic anterior or posterior muscular chains that have become weak and affected by hypertonus and retraction secondary to the underlying degenerative spinal disease. This method seeks to correct the patient's posture and decompress the spinal canal.

The therapy, which is not practiced much in the US, has become more widely used in Europe and South America, he said.

For the study, the therapy involved weekly sessions of spinal GPR technique to progressively and globally induce isometric stretching of the antigravity muscles in the supine, sitting, and standing positions.

At the initial evaluation, the affected muscles are identified by observing which posture induces pain and prompts compensatory positions by the patient. The program also used associated respiratory techniques, and a home exercise program is given. The therapy lasted for a mean of five months.

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MANY OTHER THERAPIES TRIED

Most patients had previously received different combinations of therapies for more than six months, including conventional physical therapy, rest, oral and intramuscular or intravenous anti-inflammatory medications, opioids and steroids, acupuncture, and epidural steroid injections. The average duration of symptoms was nine months, he said.

All patients had spinal MRI showing disc protrusions, canal stenosis, and other spondylotic changes. Twenty patients had cervical and 82 had lumbar disease. Eighteen had been scheduled for surgery at the time they were entered into the study. Forty-eight were women, and the age range was from 25 to 91. Seventy-five percent of the patients had moderate limitations on their activities of daily living, meaning they could not walk more than 10 blocks nonstop, and they could not complete their daily routine. Twenty-five percent were severely limited, that is, they couldn't walk more than five blocks, and they had to discontinue work or sports.

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STUDY RESULTS

Among the results: 92 (90 percent) patients reported improvement with return to daily activities; four (4 percent) reported slight discomfort with strenuous sports activity; six patients (6 percent) did not respond to therapy; and one improved after quitting a stressful job. Eighty-five percent improved in three weeks, and no patient had pain recurrence on clinic or telephone follow-up in a mean of 22 months.

Dr. Estol noted that most cases of acute back pain improved spontaneously. For the study, he specifically chose only those who had severe degenerative disc disease – evidenced by a narrowing of the spinal canal on MRI. Most had severe pain for many months. But the group included some patients who had a slipped disc and just five days of pain, as well as some who experienced pain for three years.

“Eighty-five percent received every combination of treatment you could think of,” he said. In all cases, all other efforts to heal the pain were unsuccessful, including surgery in a few cases.

They excluded patients with normal imaging, psychiatric illness, severe weakness and morbid obesity.

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METHOD MERITS RIGOROUS CONTROLLED TRIAL

Rollin M. Gallagher, MD MPH, is Director of Pain Management for the Philadelphia VA Medical Center, in the Departments of Anesthesiology and Psychiatry at the University of Pennsylvania, and Editor in Chief of Pain Medicine, the official journal of the American Academy of Pain Medicine.

Commenting on the research for Neurology Today, he said, “Their clinical approach targets weak, shortened and inappropriately used muscles and through postural changes, purports to decompress the spinal canal, providing pain relief. It is not possible, based upon the abstract, to tell if indeed these changes – strengthening muscle and decompressing the spinal canal – did occur and if they did, whether they were the mechanism for pain relief.

He added: “If pain relief is a result of the specific effects of the treatment, we cannot tell definitively because there are no controls in the study design. Assigning consecutive patients randomly – to either the new technique or to a structured form of conventional physical therapy, while not telling them or their evaluators whether they were in the experimental or conventional group, following these patients over a predetermined time and comparing the results at the end –would give a clearer result.

“With these qualifiers, I can say that their results are outstanding for this relatively large group of patients and certainly deserving of clinical trials to fully establish their efficacy,” Dr. Gallagher continued.

“Because these techniques are non-invasive and much less costly than the expensive alternatives – surgeries and multiple injections – they are worth trying in the clinic. Many commonly used medical and other unproven treatments cannot boast these results even in uncontrolled studies, so in that sense, their results are superior and also, importantly, appear to last two years!”

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MOTIVATION A FACTOR IN SUCCESS

Miroslav Backonja, MD, Associate Professor of Neurology and Anesthesiology, and Director of the University of Wisconsin Neurology Pain Clinic, told Neurology Today, “I am not surprised by these results. Our clinical experience has shown us that patients, especially those with spinal pain, who are motivated and engage actively in their pain therapies such as exercise and rehabilitation programs do significantly better.”

Dr. Backonja said, “It appears that this method has emphasized muscular conditioning and retraining, but we can guess that high degree of motivation and patient involvement played the critical role.”

He said, “The take home message for neurologists is that they should build into their practice effective working relationships with rehabilitation colleagues so that neurologists can provide better service to their patients.”

And to give doctors confidence in this approach, Dr. Backonja points to a literature review by James Wilson-MacDonald, MD, a consultant orthopedic surgeon in the Spinal Unit at Nuffield Orthopedic Centre in Oxford, England (BMJ 1996;312:39–40). Dr. Wilson-MacDonald cites prospective studies showing physiotherapy, for example, can reduce time off work in patients with first episodes of acute back by up to 50 percent.

In that article, Dr. Wilson-MacDonald also concluded, “The case for spinal fusion for back pain has not been proved.”

Dr. Estol said it was this lack of evidence for spinal fusion – despite dramatic increases in the number of surgical procedures – that led him to explore this non-medical approach in the first place.

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TOO GOOD TO BE TRUE?

J.D. Bartleson, MD, Associate Professor of Neurology at the Mayo Clinic Spine Center in Rochester, MN, said that Dr. Estol's results on GPR are so dramatic, they seem almost too good to be true. Such a positive result, he told Neurology Today, merits a confirmatory trial with controls. He would like to see more quantitative measures of improvement beyond the measures of activities of daily living that are listed in the abstract. Also, he would like to learn more about which back pain patients would benefit most with this approach.

Still, he said, it adds to the growing evidence that such non-medical approaches can play a valuable role, and also urged neurologists to develop referral networks with colleagues who can provide physical therapy interventions that have shown some success.

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ARTICLE IN BRIEF

  • ✓ Investigators from Argentina reported that a physical therapy technique effectively alleviated persistent severe back pain due to disc disease. But experts who were not involved with the study pointed out that the study lacked controls for comparison.
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©2005 American Academy of Neurology