879 People Surveyed
The intent of the survey is for the sole purpose of gathering information directly from the DDS 500 users regarding their own personal experience with the DDS 500.

● Lumbar Facet Syndrome
● Spinal Stenosis
● Spondylosis
● Disc Disease

These studies have been carried out at the Department of Orthopedic Surgery, College of Medicine, Inje University Seoul Paik Hospital. The studies were performed by Professor Byungjik Kim, Professor Shinwoo Park and their teams.​

The DDS 500 is judged to have effects on both acute and chronic low back pain caused by the following factors:

● Acute & Chronic Sprain of Lumbar Vertebrae
● Herniated Interverterbral Disc
● Bulging Disc
● Spondylolisthesis

Non-related to clinical study MRI

The Information in Below Section is Non-related to Clinical Study

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4. CONCLUSION

It was shown that approximately 85% of the subjects reported either “Excellent” or “Good” results after 3 days of using the Air Brace* (3 Excellent, 15 Good out of a total of 22 patients). In the radiographic test and isokinetic evaluation, the 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 was improved and the researchers claim that the brace, when inflated, reduces the pressure on the spinal discs by 25%. Also, it was found that the brace is very effective in the therapy for chronic lumbago and the flexibility of the extensors lasted longer. These results were obtained from both the subjective and objective examination of the patients and lead the observers to conclude that the use of Air Brace* can play an important and effective role in the treatment of both acute and chronic low back pain patients.


*The Air Brace is marketed in the United States under the brand DDS by Disc Disease Solutions.

3. Isokinetic Evaluation

Out of twelve patients included in the Isokinetic Evaluation, 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 Air Brace*. The graphs to the left, demonstrate that the extensor muscle power was sustained longer after the use of the Air Brace*. Therefore, the evaluators determined that the Air Brace* was useful in reinforcing muscular strength. From the results obtained, the increase anterior lumbar curve, as shown radio-graphically, can be said to be caused not only by physical distraction, but also by increased muscle strength. These observations continued over a two-day period.


2. Method of Study
First, MacNab’s criterion was used to examine changes of pain. Second, radiographic imaging was used to analyze the side views of the lumbar and sacral vertebrae, comparing with those x-rays before wearing the Air Brace*. Third, The Cybex 6000 Trunk Extension Flexion (TEF) Unit was used to measure and analyze muscular strength of the flexor and the extensor muscles at the lumbar vertebrae.​

RESULTS OF THE STUDY

Changes in Pain Status
MacNab’s criteria was used to evaluate the pain. “Excellent” is a state without pain, without restriction of movement and which would allow the subject to work normally. “Good” is a state with occasional pain, but would allow the subject to work normally. ‘Fair” indicates slight progress, and “Poor” reflects no progress. The results in Table 2 show that within 3 days of use approximately 85% reported favorable results. Of the total 22 subjects, three of them reported “Excellent” relief of pain and 15 subjects reported “Good” relief of pain.​

Table 2. Pain relief before and after application of air belt 
(DDS 500 Lumbar Spinal Air-Decompression Brace)


​Radiographic Changes

Side view radiographic imaging of the lumbar and sacral vertebrae on 12 patients before and after the application of the Air Brace* clearly demonstrated that the anterior curvature of the lumbar vertebrae had increased and the intervertebral disc interval at the 4th and 5th segment of the lumbar vertebrae had broadened by an average of 3mm.

Clinical Trial Study Results


1. INTRODUCTION

This study has been performed in order to evaluate the effectiveness of the Air Brace* before and after use on patients with low back pain.
Studies reveal significant decreases in pain levels and isokinetic evaluations demonstrate positive radiographic and muscular strength changes of both flexor and extensor muscles at the lumbar region.


PATIENT PROFILE AND METHOD OF STUDY


22 patients with acute or chronic low back pain; age ranging from 19 to 58 with an average age of 44 (9 men and 13 women). 8 patients with herniated disc, 9 patients with acute low back pain and 4 patients with chronic low back pain.


Table 1. Age & Sex Distribution

Clinical Study