Study design: An institutional, prospective clinical data analysis.
Objective: To evaluate the safety and efficacy of a new navigable percutaneous disc decompression device (L'DISQ) in patients with lumbar disc herniation with radicular pain.
Methods and outcome measures: We performed disc decompressions using L'DISQ on 27 patients with persistent disabling back and leg pain for 1 month or longer (average 6.48 months) due to a herniated lumbar intervertebral disc. Baseline data were prospectively gathered before the index procedure and at 1, 4, 12, and 24 weeks post-procedure. Data included pain intensity (visual analog scale [VAS]), measure of disability (Oswestry Disability Index [ODI] and Rolando-Morris Questionnaire [RM]), health-related quality of life (Bodily Pain Scale of Short Form-36 version 2 [SF-36 BP]), and passive straight leg raising test (SLR).
Results: The VAS fell from 7.08±1.22 to 1.84±0.99 scores at 24 weeks post-procedure. At 24 weeks, the ODI had fallen from 41.88±10.61 to 16.66±8.55% and the RM from 11.52±3.91 to 2.68±1.97 points. The SF-36 BP dropped significant improvement from 32.89±5.83 to 49.57±4.96 scales. In the SLR test, the angular change of 24 weeks showed considerable improvement from 60.20±20.02 to 83.00±14.29 degrees. No major complication occurred, although two cases developed a disc reherniation 1 month post-procedure.
Conclusions: The L'DISQ device is specifically designed to remove herniated disc using a wand that can be navigated into a disc protrusion or extrusion. Following decompression, we measured clinically significant pain improvement and decreased disability for patients with both radicular and axial pain caused by protruded and extruded discs.
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