A prospective, single arm study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results.

Background: The basivertebral nerve (BVN) has been a recently discovered target as a potential source for vertebrogenic chronic low back pain (CLBP). Prior randomized controlled trials have demonstrated safety and efficacy of BVN ablation for vertebrogenic CLBP, but minimal data exists regarding BVN ablation's clinical effectiveness with broader application outside of strict trial inclusion criteria. Methods: Prospective, single arm, open label effectiveness trial of 48 patients from community spine and pain practices treated with BVN ablation. Inclusion criteria required more than 6 months of CLBP and type 1 or 2 Modic changes on MRI to be enrolled. Patients were followed post procedure for 12 months using ODI, VAS, EQ-5D-5L and SF-36 patient reported outcome metrics.Results: 47 patients successfully received BVN ablation and 45 patients completed 12 months of follow up. Mean reduction in ODI at 12 months was 32.31 +/- 14.07 (p<0.001) with 88.89% (40/45) patients reporting a ≥15 point ODI decrease at 12 months. Mean VAS pain score decrease was 4.31+/-2.51 at 12 months (p<0.001) and more than 69% reported a 50% reduction in VAS pain scale. Similarly, SF-36 and EQ-5D-5L scores improved 26.27+/-17.19 and 0.22+/-0.15 (each p<0.001). Conclusions: This data supports the clinical effectiveness of BVN ablation in the community practice setting, with similar 12 month improvements in patient reported outcomes as seen in previously published randomized control trials.

Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study.

PURPOSE: To evaluate the safety and efficacy of radiofrequency (RF) ablation of the basivertebral nerve (BVN) for the treatment of chronic low back pain (CLBP) in a Food and Drug Administration approved Investigational Device Exemption trial. The BVN has been shown to innervate endplate nociceptors which are thought to be a source of CLBP. METHODS: A total of 225 patients diagnosed with CLBP were randomized to either a sham (78 patients) or treatment (147 patients) intervention. The mean age within the study was 47 years (range 25-69) and the mean baseline ODI was 42. All patients had Type I or Type II Modic changes of the treated vertebral bodies. Patients were evaluated preoperatively, and at 2 weeks, 6 weeks and 3, 6 and 12 months postoperatively. The primary endpoint was the comparative change in ODI from baseline to 3 months. RESULTS: At 3 months, the average ODI in the treatment arm decreased 20.5 points, as compared to a 15.2 point decrease in the sham arm (p = 0.019, per-protocol population). A responder analysis based on ODI decrease ≥ 10 points showed that 75.6% of patients in the treatment arm as compared to 55.3% in the sham control arm exhibited a clinically meaningful improvement at 3 months. CONCLUSION: Patients treated with RF ablation of the BVN for CLBP exhibited significantly greater improvement in ODI at 3 months and a higher responder rate than sham treated controls. BVN ablation represents a potential minimally invasive treatment for the relief of chronic low back pain. These slides can be retrieved under Electronic Supplementary Material.

Development and calibration of a load sensing cervical distractor capable of withstanding autoclave sterilization.

In surgery of the cervical spine, a Caspar pin distractor is often used to apply a tensile load to the spine in order to open up the disc space. This is often done in order to place a graft or other interbody fusion device in the spine. Ideally a tight interference fit is achieved. If the spine is over distracted, allowing for a large graft, there is an increased risk of subsidence into the endplate. If there is too little distraction, there is an increased risk of graft dislodgement or pseudoarthrosis. Generally, graft height is selected from preoperative measurements and observed distraction without knowing the intraoperative compressive load. This device was designed to give the surgeon an assessment of this applied load. Instrumentation of the device involved the application of strain gauges and the selection of materials that would survive standard autoclave sterilization. The device was calibrated, sterilized and once again calibrated to demonstrate its suitability for surgical use. Results demonstrate excellent linearity in the calibration, and no difference was detected in the pre- and post-sterilization calibrations.

Cervical spondylotic myelopathy and radiculopathy.

Appropriate management of degenerative cervical spine conditions requires careful elucidation of the presenting clinical syndrome. Because of the pervasiveness of degenerative changes in asymptomatic patients, a clear correlation of symptoms, physical signs, and imaging findings is required before any specific diagnosis can be made. At this time, surgery is not recommended for prophylactic decompression in asymptomatic patients or in those patients with neck pain in the absence of extremity symptoms. In most patients with radiculopathy or mild myelopathy, a trial of nonsurgical management is recommended. Ultimately, patients with neurologic complaints and in whom nonsurgical measures have failed, as well as those with more pronounced myelopathy, should be offered surgical intervention. Selection of the safest, yet sufficient, approach requires a clear understanding of the benefits and expected outcomes. The outlook for patients with both cervical radiculopathy and early myelopathy is good. Radicular symptoms usually improve, but gait and hand changes may not. LF is preferred in younger patients with posterolateral or lateral soft disk herniations, or focal foraminal osteophyte impingement and predominance of upper extremity symptoms. More central 1- or 2-level pathology should be treated with ACDF. Anterior cervical corpectomy should be entertained in patients with nondisk level encroachment and in those with 3 contiguous levels of pathology. This approach is also required in cases of kyphosis and instability. Laminoplasty is indicated in patients with 4 or more levels of stenosis, particularly in those with global conditions such as continuous OPLL or congenital stenosis. In these patients, kyphosis or severe deformity may be addressed with a circumferential approach.

Altered growth hormone (GH) secretion in vivo and in vitro in the diabetes-prone BB/Worcester rat.

Diminished concentrations of growth hormone (GH) have been observed in the male BB/Wor rat with diabetes mellitus (DM). The precise mechanism(s) responsible for the altered GH levels is not entirely understood. We have therefore employed independent techniques to investigate potential alterations in: 1) the peripheral metabolism of the hormone; 2) GH release by somatotropes; and 3) hypothalamic regulation of GH secretion. An extra group of insulin-untreated animals was included for the studies of acute DM. The results demonstrate diminished circulating mean concentrations of GH (35 +/- 4 vs. 16 +/- 4 micrograms/l; mean +/- SEM; control vs. animal with DM; P = 0.006) due to impaired GH secretion. In particular, there was a decrease in the mass of GH secreted per burst (230 +/- 22 vs. 136 +/- 34 micrograms/l; P = 0.04) and in the GH secretory rate (24 +/- 4 vs. 9 +/- 3 micrograms/l/min; P < 0.01). No differences in the secretory burst frequency, (5.3 +/- 0.3 vs. 5.2 +/- 0.5 #/8-h; P = 0.68), secretory half-duration (10 +/- 2 vs. 17 +/- 2 min; P = 0.09), or serum GH half-life (8 +/- 1 vs. 6 +/- 1 min; P = 0.13) were observed. In vitro studies of acutely dispersed somatotropes obtained from rats with DM demonstrated increased sensitivity to GHRH (1 nM), as detected by a greater mean hemolytic plaque area following exposure to an EC50 dose of the secretagogue (14.3 +/- 3.3 vs. 17.4 +/- 3.5 microns 2 x 10(3); P = 0.049), and diminished sensitivity to SRIH (1 nM) inhibition of GH release following exposure to an EC50 dose of the secretagogue (10.0 +/- 1.2 vs. 14.9 +/- 2.3 microns2 x 10(3); P = 0.026). The number of the pituitary cells (18.0 +/- 2.8 vs. 15.3 +/- 1.0 x 10(5) cells; P = 0.38) as well as the number of somatotropes (7.3 +/- 1.4 vs. 7.6 +/- 0.9 x 10(5) cells; P = 0.87) were indistinguishable between experimental groups. Hypothalamic gene transcript levels for GH-releasing hormone (GHRH) and somatotropin release-inhibiting hormone (SRIH) were evaluated by in situ hybridization histochemistry to assess cellular synthetic activity.(ABSTRACT TRUNCATED AT 400 WORDS)