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Clinical Trial
Effectiveness of a new navigable percutaneous disc decompression device (L'DISQ) in patients with lumbar discogenic pain.
- Sang Heon Lee, Richard Derby, Donggeun Sul, Young Ki Hong, Kang Wook Ha, Dongwon Suh, Sang Hoon Lee, Hyung Suk Yoon, Seung Han Yoo, Seok Jun Lee, Hyeun Jun Park, Yong Jin Jung, Jeong Eun Lee, and Nack Hwan Kim.
- Department of Physical Medicine and Rehabilitation, Korea University Medical Center.
- Pain Med. 2015 Feb 1;16(2):266-73.
ObjectiveThis study is a pilot study to assess the clinical outcomes of percutaneous disc decompression using the L'DISQ in patients with lumbar discogenic pain.Study DesignAn institutional, prospective clinical data analysis.MethodsWe ablated the torn annulus using L'DISQ on 20 patients with axial low back pain for at least 3 months (average 29 months) unresponsive to conservative management. Before the therapeutic procedure, all the patients had been diagnosed with lumbar discogenic pain through provocation discography, which had confirmed the level of painful discs. The torn annulus was identified through lumbosacral magnetic resonance image and computed tomographic discogram. Baseline data were prospectively gathered before the procedure and at 1, 4, 12, 24, and 48 weeks post-procedure. Data included pain intensity (visual analog scale [VAS]), measure of disability (Oswestry Disability Index [ODI] and Rolando-Morris Disability Questionnaire [RM]), and health-related quality of life (Bodily Pain Scale of Short Form-36 version 2 [SF-36 BP]).ResultsAt 48 weeks, the VAS fell from 7.55 ± 1.28 to 3.60 ± 2.28 scores, the ODI and RM had decreased significantly, and the SF-36 BP showed significant improvement (P < 0.05). The success rates of procedure were 55.0% at 48 weeks. There were no complications with the exception of a minor venous bleeding at the site of needle puncture.ConclusionsThe L'DISQ device is specifically designed to ablate adjacent disc tissue using a wand that can be navigated into a torn annulus. Following ablation, we measured clinically significant pain improvement and decreased disability for patients with axial low back pain.Wiley Periodicals, Inc.
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