Primary studies included in this systematic review

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Primary study

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Journal PloS one
Year 2012
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PURPOSE: To evaluate changes in nucleus pulposus volume as a potential parameter for the effects of disc decompression. METHODS: Fifty-two discs (T8 to L1) were extracted from 26 pigs and separated into thoracic (T8 to T11) and thoracolumbar discs (T12 to L1). The discs were imaged using 7.1 Tesla ultrahigh-field magnetic resonance imaging (MRI) with acquisition of axial T2-weighted turbo spin-echo sequences for determination of baseline and postinterventional nucleus pulposus volumes. Volumes were calculated using OsiriX® (http://www.osirix-viewer.com). After randomization, one group was treated with nucleoplasty, while the placebo group was treated with an identical procedure but without coblation current. The readers analyzing the MR images were blinded to the kind of procedure performed. Baseline and postinterventional volumes were compared between the nucleoplasty and placebo group. RESULTS: Average preinterventional nucleus volume was 0.799 (SD: 0.212) ml. Postinterventional volume reduction in the nucleoplasty group was significant at 0.052 (SD: 0.035) ml or 6.30% (p<0.0001) (thoracic discs) and 0.082 (SD: 0.042) ml or 7.25% (p = 0.0078) (thoracolumbar discs). Nucleoplasty achieved volume reductions of 0.114 (SD: 0.054) ml or 14.72% (thoracic) and 0.093 (SD: 0.081) ml or 11.61% (thoracolumbar) compared with the placebo group. CONCLUSIONS: Nucleoplasty significantly reduces thoracic and thoracolumbar nucleus pulposus volumes in porcine discs.

Primary study

Unclassified

Authors Cesaroni A , Nardi PV
Journal European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
Year 2010
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Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain >50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. Patients were randomly assigned to receive either PDD (n = 62) or CC (n = 58). Clinical outcome was determined by VAS pain score, neck disability index (NDI) score, and SF-36 health survey, collected at 6 weeks, 3 months, 6 months, and 1 year. The PDD group had significantly lower VAS pain scores at all follow-up time points (PDD vs. CC: 6 weeks, -46.87 ± 2.71 vs. -15.26 ± 1.97; 3 months, -53.16 ± 2.74 vs. -30.45 ± 2.59; 6 months, -56.22 ± 2.63 vs. -40.26 ± 2.56; 1 year, -65.73 ± 2.24 vs. -36.45 ± 2.86; GEE, P < 0.0001). PDD patients also had significant NDI score improvement over baseline when compared to CC patients at the 6 weeks (PDD vs. CC: -9.15 ± 1.06 vs. -4.61 ± 0.53, P < 0.0001) and 1 year (PDD vs. CC: -16.70 ± 0.29 vs. -12.40 ± 1.26, P = 0.005) follow-ups. PDD patients showed statistically significant improvement over baseline in SF-36 physical component summary scores when compared to CC patients at 6 weeks and 1 year (PDD vs. CC: 8.86 + 8.04 vs. 4.24 ± 3.79, P = 0.0004; 17.64 ± 10.37 vs. 10.50 ± 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a "relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement. © 2009 Springer-Verlag.

Primary study

Unclassified

Journal Journal of neurosurgery. Spine
Year 2010
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Object. Patients with radiculopathy, with or without back pain, often do not respond to conservative care and may be considered for epidural steroid injection therapy or a disc decompression procedure. Plasma disc decompression (PDD) using the Coblation SpineWand device is a percutaneous, minimally invasive interventional procedure. The purpose of this study was to evaluate clinical outcomes with PDD as compared with standard care using fluoroscopy-guided transforaminal epidural steroid injection (TFESI) over the course of 2 years. Methods. This was a multicenter randomized controlled clinical study. Ninety patients (18-66 years old) who had sciatica (visual analog scale score ≥ 50) associated with a single-level lumbar contained disc herniation were enrolled. In all cases, their condition was refractory to initial conservative care and 1 epidural steroid injection had failed. Participants were randomly assigned to receive either PDD (46 patients) or TFESI (44 patients, up to 2 injections). Results. The patients in the PDD Group had significantly greater reduction in leg pain scores and significantly improved Oswestry Disability Index and 36-Item Short Form Health Survey ([SF-36], physical function, bodily pain, social function, and physical components summary) scores than those in the TFESI Group. During the 2-year follow-up, 25 (56%) of the patients in the PDD Group and 11 (28%) of those in the TFESI Group remained free from having a secondary procedure following the study procedure (log-rank p = 0.02). A significantly higher percentage of patients in the PDD Group showed minimum clinically important change in scores for leg and back pain and SF-36 scores that exceeded literature-based minimum clinically important changes. Procedure-related adverse events, including injection site pain, increased leg or back pain, weakness, and lightheadedness, were observed in 5 patients in the PDD Group (7 events) and 7 in the TFESI Group (14 events). Conclusions. In study patients who had radicular pain associated with a contained lumbar disc herniation, those patients treated with PDD had significantly reduced pain and better quality of life scores than those treated using repeated TFESI. In addition, significantly more PDD patients than TFESI patients avoided having to undergo a secondary procedure during the 2-year study follow-up.

Primary study

Unclassified

Authors Birnbaum K
Journal Surgical and radiologic anatomy : SRA
Year 2009
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Background: Cervical disc nucleoplasty is a significant and clinically demonstrated innovation in percutaneous disc decompression in case of non-herniated disc protrusions or prolpase. It allows a percutaneous decompression via a 19-gauge needle under utilization of the Coblation® technique and under C-arm control. Until now the patients suffering of a cervicobrachialgia in cause of a disc prolapse had only the therapeutical solution between conservative treatment and monosegmental spondylodesis or disc prosthesis of the mentioned motion segment. Methods: We wanted to demonstrate a new and practicable anatomical pathway for reaching the cervical disc prolapse comparable to the technique for discography of the cervical spine. The introducer needle is advanced into the disc under fluoroscopic guidance using a standard anterior - lateral approach. The controller delivers radiofrequency energy to quickly ablate tissue at temperatures between 50° and 60°C. The decompression will be done in ablation mode by rotating the device through 180° for 5 s in the posterior, medial and ventral third of the cervical disc. After failed conservative treatment over an average time period of 3 months we treated 26 patients with a contained herniated prolapse or protrusion with radicular arm pain by percutaneous decompression under utilization of the Coblation® technique with a controlled energy plasma-mediated field. A randomized control group of 30 patients was treated alone conservatively with medical and physical therapy in the same period. Results: The average preoperative VAS was 8.8. With a follow-up time of 2-years we found an average pain reduction with the visual pain score (VAS) of 2.3 who had a further check-up. The VAS was checked 24 h, 1 week, 3, 6, 12 and 24 months postoperatively. No complications with this method were seen. Comparable to the surgically treated group the conservative patients have had a VAS of 8.4. Under using conservative treatment with physical therapy, physiotherapy, analgetics and perineural injections we have had a diminution of the VAS to 5.1 after 2 years. Conclusion: The percutaneous decompression of the cervical disc protrusion with the Perc DC® - Spine Wand by using the Coblation mode is a quick and safe procedure. Furthermore, one may state a persistent pain relief in the follow-up time up to 2 years after the percutaneous decompression of the disc. © pringer-Verlag 2009.

Primary study

Unclassified

Journal Acta neurochirurgica. Supplement
Year 2005
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In this study two strategies in the treatment of Mechanical Spinal Discogenic Pain have been compared: Disc Coablation and Epidural Injection of Steroids. In 2003 50 patients treated with one or two epidural injections have been selected "ad random" and 50 patients treated with disc coablation. Comparison of the data indicated an improvement of average VAS when relaxed for both groups (p < 0.01), while after slight-moderate strain, this value was significant only after coablation (p < 0.001). Finally, average VAS was clearly lower (p < 0.01) after coablation as compared to epidural injections.

Primary study

Unclassified

Authors Nardi PV , Cabezas D , Cesaroni A
Journal Acta neurochirurgica. Supplement
Year 2005
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Conventional open cervical discectomy, with or without bony fusion, in common neurosurgical knowledge is considered the standard treatment for cervical disc herniation. Percutaneous procedures are minimally invasive and offer decreased morbidity, require no bone graft and promise shorter recuperation time. Nevertheless, candidates for a percutaneous procedure as inclusion criteria must complain of symptoms related to contained herniated disc or focal protrusion. It does not substitute conventional open procedures required for extruded discs. We used the coblation technology for nucleoplasty of the cervical intervertebral discs. Early and long-term effects and/or complications observed with this procedure have not been reported yet. Fifty consecutive patients presenting with contained herniated cervical disc or focal protrusion causing compression of the cervical roots or cervical pain underwent a nucleoplasty procedure on the pathological disc. A randomized control group of twenty patients was treated conservatively with medical and physical therapy in the same period and completed the identical follow-up form. In the nucleoplasty group results were complete resolution of symptoms in 80% of cases, only 10% referred some residual cervical or radicular pain and are still under follow-up with a wait-and-see prospective. Patients who did not have a clinical resolution were treated with alternative traditional methods (10%). Despite the relative low cases number and the limited follow-up the encouraging results induce us to utilize this technique in well-selected cases.