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.