Efficacy of VAX-D on chronic low back pain: Study of dosage regimen
Gustavo Ramos M.D., Department of Neurology and Radiology
Rio Grande Regional Hospital, McAllen Texas
(page two of six)

All patients had failed standard medical therapy and the average duration of symptoms for the group was over 3 years ( 43 months). A prospective randomized control trial conducted on patients suffering from chronic low back and leg pain reported that 68% of the group on VAX-D achieved remission . Statistical analysis established that the success rate with VAX-D was significantly higher than the control group. (22). A long term study that followed the progress of cases four years after VAX-D found that more than 50% had remained in remission without further treatments and 91% had been able to resume their normal daily activities. (23) Published data has also demonstrated the effectiveness of VAX-D in reversing sensory nerve dysfunction in patients with compressive radiculopathy (24,25)

VAX-D has a direct effect on the disc through reduction of intradiscal pressure, thereby achieving medical decompression. Ramos and Martin performed intradiscal pressure measurements during treatment with VAX-D and pressures as low as minus 150mmHg. were recorded (26). Intradiscal pressures have been measured with conventional traction devices, both active and passive. A significant reduction in pressure was never observed, in fact active traction doubled intradiscal pressures (27). Biomechanical studies have implicated elevated intradiscal pressures in the equation for annular failure. (28,29,30,31,32)

VAX-D applies distraction tensions to the patients lumbar spine without eliciting reflex paravertebral muscle contractions. This differentiates this procedure from conventional traction (33). A computer programmed logic computer, which accepts feedback during distraction, features in the unique performance. The resultant time- energy curve for VAX-D is logarithmic and has been described mathematically in the patent on the procedure.

The procedure is very safe and patient friendly. The patient lies prone, the upper body is over the stationary portion of the table, and the body is restrained by the patient holding on to adjustable hand grips, which can be released at any time for safety. The table is a split table design, whereby distraction tensions are applied to the patient through a pelvic harness attached to a tensionometer and by separation of the movable part of the table. The distraction-relaxation cycles are automated and variably timed. Each distraction and relaxation cycle is captured on a chart printout, providing the operator with a time-energy curve that allows constant monitoring of the patient. Fatigue, decompression, and excessive muscle contraction can be observed from the chart printout. This allows the operator to adjust the therapy. The protocol has been formally amended since initiating this study. Patients receive on average 20 daily sessions, employing tensions from 55 to 85 pounds. Each session is 15 cycles characterized by I minute in distraction and 1 minute in relaxation. Once the patient is asymptomatic or the clinical symptoms have reached a plateau the tension is reduced by for the remaining course of therapy.

Indications for VAX-D are patients with low back pain (Quebec 1,2, or 3) due to disc disease who have not responded appropriately to standard medical therapy. In the Gose study, the best responses were observed in patients with subligamentous hernias (21). Contraindications to therapy are cauda equina syndrome, tumor, infection, severe osteoporosis, fracture, bilateral pars defect, unstable spondylolisthesis and the presence of surgical instrumentation.

Patients with symptomatic osseous lateral stenosis are poor candidates and patients with osseous central canal stenosis are not expected to respond.

The purpose of this study was to evaluate the response to VAX-D therapy in patients with chronic low back pain with or without leg pain who were referred to a neurosurgical clinic after failing standard medical therapy. Patients who were considered appropriate candidates for surgery underwent surgery.

MATERIALS AND METHODS

The patient population for this trial consisted of patients were who referred for neurosurgical evaluation after exhausting standard medical management by family practitioners, internists, orthopedist, physical therapist and chiropractors in the Rio Grande Valley, Texas. Over 150 new patients are seen annually and about 40% undergo surgery. Patients were selected for VAX-D therapy if they had contained discs, non-progressive neurological deficits and no contraindications to VAX-D therapy. Some patients considered surgical candidates refused surgery and opted for VAX-D therapy. Patients with stable neurologic deficits underwent treatment with the VAX-D. All patients had imaging studies (MRI or CT scan) prior to VAX-D therapy to confirm the diagnosis of a discogenic disorder that was consistent with the clinical findings.

The average duration of symptoms was 10 months. Most patients were between 30 and 50 years of age, the youngest was 15 years and the oldest 76 years. The average age was 39.5 years. Fifty-five (55) women and eighty-seven (87) men took part in this study.

Patients receiving VAX-D therapy were required to stop all other forms of therapy during their treatment period and for 4 weeks after terminating therapy. This included any modalities, back exercises, or stretching programs. Medications were allowed on a prn basis.

1 | 2 | 3 | 4 | 5 | 6

return to LCD Research page