Treatment Guidelines

VAX-D treatment is recommended for patients with pain from intervertebral disc pathology (lumbar or cervical) that have not had spontaneous recovery in the first four weeks since the onset of symptoms.

The pathophysiologic mechanisms for low back pain are still not well understood. It is believed that increases in discpressures resulting from heavy lifting, rotation, vibrational and postural forces etc. are important factors in the pathogenesis of low back pain. Occupational groups with the highest estimated prevalence of low back pain are those that involve routine repetitive lifting such as heavy industry, nursing, mechanics and repairers of vehicles, operators of equipment for material moving and mining, and people in the construction trades and related occupations. The effects of disc hydraulics in herniations or protrusions may cause a deformation of the nerve roots and a compression-induced impairment of the vasculature. In addition, it has been found that the biochemical properties of the nucleus pulposus may induce a toxic or inflammatory reaction in the nerve root.

Ramos and Martin (1994) have reported that VAX-D enables a healthcare practitioner to lower intradiscal pressure and decompress the intervertebral lumbar discs and nerve roots under precisely controlled, monitored conditions, without surgical intervention and without destruction of the bio-mechanical function of the spinal segments.

Critical exclusionary diagnoses include such conditions as cauda equina syndrome, progressive neurological deficit, fractures, neoplasm, spinal instability, infection, hard tissue stenosis and extra-spinal conditions.

The goal of treatment is to help reduce the patient’s symptoms. There is now a whole industry of low back pain equipment (including many traction devices) making claims that decompression tables will lower the disc pressure, retract the herniated nucleus pulposus and restore the disc to normal.

While we have seen some cases were pre- and-post MRI’s demonstrate the reduction of a herniation, this is not a general finding, nor is it a requisite for success. We have seen many cases were there is little or no change on a post-treatment MRI, yet the patient has had a successful outcome. So this begs the question- if we are not reducing the herniation in these patients- how is the treatment successful?

There are several plausible explanations for the mechanism of action of VAX-D; these include the following:

(a) lowering the intradiscal pressure for 20 days will help to reduce the hydro-static effects of the nucleus pulposus on the surrounding tissues;
(b) lowering the disc pressure will help to reduce the mechanical compressive injury to the surrounding tissue;
(c) reduction of the compressive injury may assist the body in reducing the inflammatory cascade (production of prostaglandins and leukotrienes);
(d) lowering the disc pressure should increase the diffusion gradient of fluids –from the vertebral endplate- into the disc
(e) increasing the diffusion gradient into the disc may have the same beneficial effects that normal perfused tissue require for health (supply of fluids, nutrients, oxygen, cells, and exchange of the normal biological catabolytes)

More clinical studies need to be done in order to investigate and quantify the mechanism of action and the changes that occur in the disc with decompression treatment.

For patients presenting with acute symptoms for the first time, the physician can initially proceed with up to four weeks of treatment which may include some combination of the recommended therapies including, education, activity modification, drug therapy and epidural injections if indicated. The specific choice of treatments will depend both on the medical experience of the practitioner and the severity of the patient's complaints.

Since a large percentage of low back pain is a self-limiting problem of relatively short duration, the majority of patients can be expected to improve significantly during the first four weeks. For this reason, imaging techniques beyond routine lumbar spinal x-rays are not indicated in the initial phase of treatment. If the specific symptoms resolve in four weeks then the patient is encouraged to return to regular activities.

The principle recommendations for assessing and treating patients with low back or neck pain include the following:

1. Initial assessment of patient with acute low back problems with a focus on detecting serious systemic or local disease (red flags).

2. Initiation of VAX-D treatment in the intermediate/secondary phase (after the first four weeks).

3. Only patients with progressive neurological deficits, cauda-equina syndrome or spinal instability are considered early surgical candidates. Research indicates that in the absence of these conditions, surgical patients have the same long-term outcomes as those who receive effective non-operative care.

The determination of whether or not a patient is a candidate for VAX-D treatment is based upon a combination of patient history, physical findings and in some cases imaging studies. Current plain films are required to rule out contraindications such as fractures and/or space occupying lesions. Each potential patient must go through a consultation, a focused medical history and work history as well as a physical and psychological assessment.

Patients with discogenic low back pain syndrome require one treatment session each day. A normal treatment session is approximately 45 minutes duration plus the time it takes for patient set-up and discharge .

The patient receives treatment not less than 5 times per week over a 4-week period. The total number of sessions is determined by the severity of the patient’s condition and by their response to treatment. The treatment benefits are cumulative in nature and are not to be given 2-3 times per week. The maximum benefit would be derived from treatment 7 days per week or treatment given twice per day 7 days per week.

An outcome study by Naguszewski and Gose (Department of Bioengineering, University of Illinois at Chicago) involving 778 patients with data collected from twenty-two medical centers reported that the average number of treatment sessions was nineteen. Only patients with diagnosis of herniated disc, degenerative disc disease or facet syndrome, which were confirmed by diagnostic imaging were included in the study.

They reported the treatment was successful in 71% of the 778 cases, when success was defined as a reduction in pain to 0 or 1, on a 0-5 scale. They also reported that improvements in mobility and activities of daily living (ADL’s) correlated strongly with pain reduction.

The average decrease in pain, plus or minus the standard error of the estimate, was 2.88 /-0.05 units on a scale of 0-5, and a paired two-sample T-test shows that this pain decrease was at least 2.68 units with p<0.00005. The average increase in mobility was 1.17 /- 0.03 on a 0-3 scale, and this value was at least 1.04 units with p value of <0.00005. Similarly, the average increase in the activity score was 0.96 /-0.04 units on a 0-3 scale, and this average improvement was at least 0.83 with p value of <0.00005.

On a rating scale of 0 to 3, increases in spine mobility of one grade or more was seen in 77% of the patients with mobility limitations. Functional increases of 1 or more grades in the activity score was recorded in 78% of the patients who, before treatment were either unable to walk or capable of only limited walking. The coefficient of linear correlation between mobility and pain scores was 0.72.

Between pain and activity the correlation was 0.60, and between activity and mobility it was 0.59. On a scale of 0 to 3, the average satisfaction with treatment was 2.4, which lies between 'very satisfied' and 'completely satisfied'.

Post Surgical Cases: In the above study, 31 patients had previous lumbar disc surgery. MRI scans showed scar tissue their mobility scores and 61% of their activity scores improved by one unit or more with therapy. In 65% of the group the pain scores were reduced to 0 or 1.

A two year study on the treatment of chronic back pain sponsored by Independence Blue Cross, a leader in the insurance industry, has now been released. The purpose of the study was to determine short- and long-term outcomes after VAX-D treatment in a large sample of patients with activity-limiting low back pain that had failed at least two previous, non-surgical treatments.

The sample was primarily composed of middle-aged adults who were currently working and reported moderate to high pre-intervention pain intensity (range, 3.9 –7.3) and moderate pain-related activity limitation. Most subjects had symptoms of greater than 6 months in duration.

In this study all subjects had pre-intervention imaging evidence of lumbar intervertebral disk degeneration and/or herniation.

The study showed that patients had significantly improved pain and disability scores at end of treatment, at 30 days and at 180 days post-discharge.

The study on VAX-D was designed, written and analyzed by Expert Clinical Benchmarks, headed up by Paul Beatty, Clinical Associate Professor, Department of Exercise Science at the University of South Carolina.

The study design was a longitudinal single blind prospective case series, the third most reliable outcome measuring tool.

Sherry, Kitchener and Smart conducted a prospective randomized controlled study of VAX-D and TENS (as the control) for the treatment of chronic LBP. The study was designed by Quintiles and the Human Research Ethics Committee, University of Wollongong, NSW, Australia. They reported that VAX-D demonstrated a success rate of 68.4% and a success rate of 0% with TENS in forty-four patients (p<0.001).

The Australian National Musculoskeletal Initiative instructed the investigators on the use of instruments for the outcome measures. Data analysis was conducted by Quintiles, the world's largest health care consultancy organization that conducts clinical trials for companies producing or using health care products, including the world's leading drug companies.

The results of this RCT demonstrate that VAX-D can achieve a statistically significant improvement in pain and functional outcome, and that VAX-D is an effective treatment for the management of patients suffering from disc related chronic low back pain. These findings are consistent with earlier studies by Gose E, Naguszewski W, Naguszewski R.

Patients with advanced pathology at multiple levels may require more treatments. Gose and Naguszewski reported a success rate of 72% for 195 cases with multiple herniations. The cases went from 4.13 to 1.18, a reduction of 71% in pain.

They also reported that VAX-D treatment was 53% successful in 34 cases with extruded herniated discs.

Patients are instructed not to begin treatment unless they are able to commit to a daily treatment schedule.

If travel or scheduling for treatment over four weeks presents a problem for a patient, that patient may elect to schedule two sessions per day. The treatments are scheduled as far apart as possible. Patients with ‘Internal Disc Disruption’ (IDD) may require more treatments than the average, and they require a specific drug regimen (Matrix Metalloproteinase Inhibitor/Doxycycline and steroid/methylprednisolone).

The patient remains under the physicians care for four weeks after their treatment has been completed in order to monitor their condition, symptoms, and activities. General activity is encouraged during this period but the patient must refrain from exercises that increase intradiscal pressures and/or torsional strain on the lumbar spine.

Patients are encouraged to remain at light duty work during VAX-D treatment (or modified work activity) providing work activities do not aggravate their condition. Absence from work has negative aspects, and return to work has a variety of benefits for the patient, and prevents de-conditioning and disabling inactivity, it reinforces the patient’s self esteem and sense of well-being. In many cases, if the patient remains inactive at home, this may lead to muscle and joint soreness, a loss of muscle tone and mass, and an increase in pain and stiffness.

Naguszewski Naguszewski and Gose used Dermatomal Somatosensory Evoked Potentials (DSSEPs) to demonstrate lumbar nerve root decompression following VAX-D therapy. Traditionally, the term “decompression” as applied to the spine has referred to surgical nerve root decompression. DSSEPs are the traditionally accepted technology used to measure relief of neurocompression with surgery.

In this study patients suffering from chronic low back pain and radiculopathy had multiple nerve root abnormalities based on abnormal DSSEPs. Successful treatment by VAX-D therapy resulted in clinical reduction in pain and improved DSSEP waveforms demonstrated that nerve root decompression occurred at multiple levels. The average pain reduction was 77% .

Tilaro and Miskovich also reported on the effects of VAX-D on sensory nerve dysfunction in patients with LBP and radiculopathy. The group of patients in this study received VAX-D therapy and Current Perception Threshold (CPT) neurometer testing. CPT readings on 22 peripheral nerves were taken before and after VAX-D therapy. Only patients with initial abnormal CPT readings, symptoms of sciatica, positive Straight Leg Raise, and positive imaging studies were reported on.

The results after therapy were as follows: Ninety-one percent (91%) demonstrated improved neurological function measured by the CPT Neurometer after VAX-D therapy. Sixty-four percent (64%) of the patient showing abnormal dysfunction secondary to a compressive radiculopathy achieved complete recovery of neurologic function. Of the remainder 27% showed improvement, 4.5% had no improvement and 4.5% showed deterioration.

Overall improvement was statistically significant at p<0.05.

The data from these studies demonstrates that the VAX-D therapeutic table is capable of improving spinal sensory nerve dysfunction in abnormal nerves secondary to a compressive radiculopathy.

Boudreau and Odell have reported excellent four-year results in a series of patients with chronic discogenic low back pain treated with VAX-D. This retrospective survey included 34 patients treated between January and April 1995; of these, 23 patients responded. All had undergone several types of treatment before receiving VAX-D. On average patients underwent 15 treatments. Those who received more treatments tended to have better pain relief. Subsequent studies have shown that patients with single-level discogenic disease require 20 treatments, but patients with multilevel discogenic disease may require more.

Progress was measured with Visual Analogue Scale (VAS) pain scores. A 50% reduction in score was considered a successful result. At four years, patients were sent a questionnaire survey by mail (and surveyed by telephone if the questionnaire was not returned).

“Among 23 patients, 71% showed more than 50% reduction in pain immediately after treatment, and 86% showed a 50% or better pain reduction at four years. After four years, 52% of respondents reported a pain level of zero. “

“91% were able to resume their normal daily activities, and 87% were either working or were retired without having back pain as the cause for retirement.”

“The average pain level was 7.41 before VAX-D treatment and 3.41 immediately afterward and at four years the level had dropped to 1.57. None of the respondents underwent surgery for their back condition after receiving VAX-D treatment.”

Therapeutic Indications For VAX-D

1. Low back pain, unilateral or bilateral, with or without leg pain and symptoms – asscociated with intervertebral disc disease.
2. Failed Back Syndrome in patient without retained hardware.
3. Cervical pain with or without associated radiculopathy.

Contraindications and Potential Risks for VAX-D Patients

1. Primary or metastatic neoplasm in the spine
2. Vertebral Fracture [recent]
3. Cauda equina syndrome
4. Unstable spondylolisthesis (eg Pars Defects)
5. Osteoporosis (DEXA T-Score of -2.5 Standard Deviations below mean)
6. Severe (or unstable) medical disorders
7. Pregnancy
8. Ankylosing spondylitis
9. Arthrodesis with retained hardware
10. Abdominal aortic aneurysm
11. Spinal infections including osteomyelitis and septic discitis
12. Moderate to severe osseous stenosis
13. Any pathological or congenital deformities of the vertebral column that disrupt the integrity of the vertebral and/or ligamental structures
14. Previous treatment with IDET / Nucleoplasty / Vertebroplasty