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 three of six)
All patients received 15 distraction and relaxation cycles per day on a daily basis administered five days per week. A complete session takes 30 to 45 minutes. Therapy was initiated at 55 to 65 pounds and increased to 70-90 pounds as tolerated. In a previous publication (26) by the author, 40 -50 pounds was the required threshold necessary to achieve negative intradiscal pressure. The treatment procedure administered to all patients was the same except for the number of sessions employed as the prescribed course of therapy. The prescribed course of therapy employed for a period of time was limited to 10 daily sessions (10 Sessions Group). Subsequently the prescribed course of therapy was increased to 20 daily sessions (20 Sessions Group) . Patients that achieved remission prior to completing the prescribed number of treatment sessions were included in the results for the assigned group but were not required to complete the prescribed course of therapy. The average course of therapy in the 10 Sessions Group was 9 daily sessions whereas the 20 Sessions Group received on average 18 daily sessions.
The level of pain on a scale of 10, with 0 as no pain and 10 as the worst possible pain, was recorded on each patient prior to the onset and on completion of the prescribed course of treatment . Each patient also recorded their Activities of Daily Living (ADL) on a scale of 0 to 5 with 0 being no impediment to 5 being confined to bedrest.
RESULTS
One hundred and forty-two patients that were consecutively treated with VAX-D therapy were included in this study. Table 1. shows the distribution of the diagnosis of the cases treated in this series. There were ninety-one (64%) patients in the 10 Sessions Group and fifty-one (36%) patients in the 20 Sessions Group .
Remission was defined as 90% or greater relief of pain, back to work without limitations, and ability to carry out ADL'S. Partial remission was defined as persistence of some pain but ability to carry out most ADL's and return to work with some restriction of duties, depending on the occupation. Negative response was defined as no change in the level of pain and/or ADL
Table 1: Case Distribution by Diagnosis.
| Number of Cases |
Diagnosis Confirmed by Diagnostic Imaging |
| 111 |
Subligamentous Herniation |
| 41 |
Multi-level Herniations |
| 16 |
Extruded Herniation |
| 50 |
Degenerative Disc Disease |
| 54 |
Neurological Deficit |
| 13 |
Stenosis |
| 4 |
Spondylolisthesis |
| 3 |
Failed Back Surgery |
| 2 |
Fibrosis from Previous Surgery |
|
Table 2. illustrates patient response according to the dosage regimen. Figure 1. illustrates the frequency distribution in a bar chart format. Results from the two dosage groups clearly indicate that patients receiving more then ten treatments had a better response with 76% in the 20 Sessions Group achieving remission whereas it was 43% in the 10 Sessions group. If one excludes the patients with stenosis the remission rate of the 10 Sessions Group is still significantly different than the 20 Sessions group (48% and 76% respectively). Partial response was similar in both groups but the 10 Sessions Group had a failure rate of 33% while the 20 Sessions Group had a failure rate of only 4 %.
The frequency distribution of responses observed with the two groups of cases was compared using a Chi-Square statistical analysis.
The difference in the frequency response, as show in Table 2, between the 10 Sessions group and the 20 Sessions group was statistically significant at p< 0.0001.
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