Superbax Clinical Trial Results
These studies have been carried out at the Department of Orthopaedic Surgery, College of Medicine, Inje University Seoul Paik Hospital by Professors Byungjik Kim and Shinwoo Park and their teams.
1. Introduction
This study into the performance of the efficacy of Superbax after use by patients with low back pain has evaluated pain levels, radiographic changes and strength of both flexor and extensor muscles at the lumbar vertebrae by usinng an isokinetic evaluation device.
2. The Subject and Methods of study
22 patients with acute or chronic lumbago; age ranging from 19 to 58 with average age of 44, 8 patients in the age range of 50 to 59 years, 9 men and 13 women, 9 patients with herniated disc, 9 patients with acute lumbago and 4 patients with chronic lumbago.
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Method of Study
Firstly, Macnab's criteria were used to examine changes of the pain. Secondly, radiographic imaging was used to analyze side views of the lumbar and sacral vertebrae, comparing with those Trunk Extension Flexion (TEF) Unit was used to measure and analyze muscular strength of the flexor and the extensor at the lumbar vertebrae.
3. Result of the study
Macnab's criteria were measured as follows: Excellent is a state without pain, without restriction of movement and which would allow the patient to work normally. Good is a state with occasional pain, but which would allow the subject to work normally.Fair indicates slight progress and Poor reflects no progress. The results in Table 2. show that approximately 85% reported favourable results with 3 subjects reporting Excellent relief of pain and 15 reporting Good relief of pain (out of 22 patients).
| Table 2. Pain relief before and after application of Air corset (Superbax) | |||||||||||||||
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Radiographic Changes
Firstly, Macnab's criteria were used to examine changes of the pain. Secondly, radiographic imaging was used to analyze side views of the lumbar and sacral vertebrae, comparing with those Trunk Extension Flexion (TEF) Unit was used to measure and analyze muscular strength of the flexor and the extensor at the lumbar vertebrae.
Isokinetic evaluation
Out of twelve inpatients, three were randomly selected for evaluation using the Cybex 6000 - Trunk Extension Flex(TEF) unit. According to the results from comparing the total joule at 60 angular velocity, peak torque, the ratio of peak torque to weight and average muscle power measured before and after the application of the Superbax, the following graphs demonstrate that extensor muscle power was sustained longer after the use of the Superbax. Therefore, we decided that the Superbax. was useful in reinforcing muscular strength. From the results obtained, the increased anterior lumbar curve, as shown radiographically, can be said to be caused not only by physical distraction, but also by increased muscle strength.
4. Condition
It was show that approximately 85% of subjects reported either Excellent or Good results after 3days of using the Superbax (3 Excellent, 15 Good out of a total of 22 patients). In the radiographic test and isokinetic evaluation, increase in the anterior curvature of the lumbar vertebrae and increased distraction between the fourth and fifth lumbar vertebrae were found. Also, the mobility of extensor muscles were improved. These results were obtained from both the subjective and objective examination of the patients and lead us to believe that use of Superbax can play an important and effective role in the treatment of both acute & chronic low back pain patients.
5. Efficacy and Effect of Superbax
Superbax is judged to have effects on both acute and chronic low back pain caused by the following factors:
- The acute & chronic sprain of lumbar vertebrae
- Herniated intervertebral disc.
- Spondyloysis and Spondylolisthesis
- Spinal stenosi