Short-term clinical and radiographic outcomes of chemonucleolysis with condoliase for painful lumbar disc herniation and analysis regarding intradiscal injection area.

Percutaneous chemonucleolysis with condoliase has been available for painful lumbar disc herniation since 2018 in Japan. This study investigated clinical and radiographic outcomes three months after the administration because the secondary surgical removal is most required during this period for the insufficient pain relief, and analyzed whether the differences of intradiscal injection areas affected the clinical outcomes. We retrospectively investigated 47 consecutive patients (males, 31; median age, 40 years) three months after the administration. Clinical outcomes were evaluated using the Japanese Orthopaedic Association Back Pain Questionnaire (JOABPEQ), a visual analog scale (VAS) score for low back pain, and VAS scores for pains and numbness in the lower limbs. Radiographic outcomes were analyzed in 41 patients, using parameters such as mid-sagittal disc height and maximal protrusion length of herniation on MRI preoperatively and at the final follow-up. Postoperative median evaluation period was 90 days. The effective rate of low back pain based on the pain-related disorders at baseline and the last follow-up in the JOABPEQ reached 79.5%. The postoperative proportion of VAS scores recovery ≥ 2 points and ≥ 50% for pains in the lower limbs were 80.9% and 66.0%, respectively, revealing satisfactory effectiveness. Preoperative median mid-sagittal disc height significantly reduced from 9.5 to 7.6 mm postoperatively. There were no significant differences in pain relief in the lower limbs by injection areas in the center and the dorsal 1/3rd near the herniation of nucleus pulposus. Chemonucleolysis with condoliase revealed satisfactory short-term outcomes after the administration regardless of intradiscal injection areas.

Acute prevertebral abscess secondary to intradiscal oxygen-ozone chemonucleolysis for treatment of a cervical disc herniation.

Objective We herein present a case involving a prevertebral abscess complicated by a spinal epidural abscess (SEA) secondary to intradiscal oxygen-ozone chemonucleolysis for treatment of a cervical disc herniation. Methods A 67-year-old woman with a history of intradiscal oxygen-ozone chemonucleolysis developed numbness and weakness in her right upper and bilateral lower extremities followed by urinary retention. Her symptoms did not respond to intravenous antibiotics alone. Magnetic resonance imaging of the cervical region revealed an extensive SEA anterior to the spinal cord, spinal cord myelopathy due to anterior compression by the lesion, and a prevertebral abscess extending from C2 to T1. She underwent surgical drainage and irrigation. Results The patient was successfully treated with surgical drainage and systemic antibiotic therapy without kyphosis. Streptococcus intermedius was detected within the abscess. All clinical symptoms except for the sensory deficit in the left leg were relieved. Conclusions The safety of intradiscal oxygen-ozone therapy requires further assessment. High-dose intravenous antibiotics should be initiated empirically at the earliest possible stage of prevertebral and epidural abscesses. Surgical drainage may be a rational treatment choice for patients with a prevertebral abscess complicated by an SEA and spinal cord myelopathy.

Rational approach, technique and selection criteria treating lumbar disk herniations by oxygen-ozone therapy.

Radicular lumbar back pain is an important public health problem not yet benefiting from a unequivocal treatment approach. Medical and physical therapies represent the first solution; however, when these fail, the second therapeutic step is still controversial and mini-invasive treatments may play an important role. In these cases oxygen-ozone therapy has been proved to be a very safe and effective option that is widely used with different modalities. This paper, by reviewing oxygen-ozone therapy literature data, aims to describe the rationale of oxygen-ozone therapy for the treatment of lumbar disk herniations, propose an effective procedural technique and clarify patient selection criteria; furthermore, complications and follow-up management are also considered.

L5-S1 Achromobacter xylosoxidans infection secondary to oxygen-ozone therapy for the treatment of lumbosacral disc herniation: a case report and review of the literature.

STUDY DESIGN: Case report and literature review. OBJECTIVE: To present a unique case of Achromobacter xylosoxidans infection secondary to oxygen-ozone therapy for the treatment of L5-S1 disc herniation. SUMMARY OF BACKGROUND DATA: Oxygen-ozone therapy is a minimally invasive technique for the treatment of lumbar disc herniations, with unproven efficacy and few reported complications. Achromobacter xylosoxidans is an opportunistic pathogen that inhabits aquatic environments and is a rare cause of osteomyelitis. To the best of our knowledge, this is the first report of A. xylosoxidans spondylodiscitis in the lumbar spine and the third report of spinal infection after intradiscal oxygen-ozone chemonucleolysis in the English literature. METHODS: The medical records, operative reports, and radiographical imaging studies of a single patient were retrospectively reviewed. RESULTS: A 29-year-old female patient who previously underwent oxygen-ozone therapy for L5-S1 disc herniation presented to our institution with a 5-month history of intractable back and leg pain. The patient's laboratory studies were within normal limits and did not indicate signs of an active infection. Her physical examination revealed globally decreased muscle strength (4/5) and hyperesthesia in the lower extremities. Magnetic resonance imaging and computed tomography revealed severe disc degeneration and vertebral body endplate changes at L5-S1, in addition to paravertebral soft tissue swelling consistent with a previous infection. Given the severity of symptoms, the patient underwent anterior lumbar interbody fusion and posterior segmental instrumentation at L5-S1. Histopathological evaluation of the disc material confirmed the diagnosis of chronic osteomyelitis and septic discitis at L5-S1. Intraoperative cultures grew A. xylosoxidans and Propionibacterium acnes. The patient had prompt improvement in her level of pain and was discharged on a 6-week course of piperacillin-tazobactam without complication. CONCLUSION: This first report of A. xylosoxidans vertebral infection secondary to oxygen-ozone therapy illustrates the wide variety of environmental pathogens that can complicate the percutaneous treatment of degenerative vertebral disease.

Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part II: the radiological outcome.

STUDY DESIGN: A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery. OBJECTIVE: To compare the radiological findings preoperatively with the clinical outcome between the groups at 1 year, 10 to 13, and 24 to 27 years of follow-up. SUMMARY OF BACKGROUND DATA: Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. However, it ceased to be manufactured in 2001. METHODS: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. Preoperatively, their anteroposterior, lateral lumbar spine, and lateral lumbosacral angle radiographs were obtained, and a myelogram was performed. At 10 to 13 years, 32 of the original patients (18 chemonucleolysis and 14 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were assessed by lateral lumbosacral angle radiographs. RESULTS: Using the myelographical findings, small, medium, and large herniations were digested by chymopapain with more of the failures being the larger ones. There was an equal degree of degenerative change as measured by disc height loss in the young and older age groups and the degree of degenerative change did not relate to outcome. The size of the defect did not relate to the degree of disc height loss. There was a slight loss of disc height over time in both groups. There was no difference in the loss of disc height between the treatments at any of the follow-up time points. CONCLUSION: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis. The loss of disc height over time is the same in both groups. The authors think that restoration of its availability would be beneficial to patients. LEVEL OF EVIDENCE: 1.

Prospective randomized trial of chemonucleolysis compared with surgery for soft disc herniation with 1-year, intermediate, and long-term outcome: part I: the clinical outcome.

STUDY DESIGN: A prospective consecutive series of 100 patients computer randomized into 2 groups to have treatment by either chemonucleolysis or surgery. OBJECTIVE: To compare the complications and clinical outcome between the groups at 1 year, and at 10 to 13 and 24 to 27 years. SUMMARY OF BACKGROUND DATA: Chemonucleolysis was introduced in 1964 and became widely used. Its efficacy was proven by several randomized studies when compared with a placebo and surgery. The manufacturing of Chemonucleolysis was ceased in 2001. METHODS: One hundred consecutive patients were enrolled for the study and randomized according to age, sex, and disc level. They were followed up at 1 year with self-assessment questionnaires to establish if they were completely better, improved, the same or worse. At 10 to 13 years, 61 patients (32 chemonuceolysis and 29 surgery) and at 24 to 27 years, 45 patients (24 chemonucleolysis and 21 surgery) were self-assessed by questionnaire according to the Macnab criteria. RESULTS: Forty-eight patients were treated by chemonucleolysis and 52 by surgery. Ten patients treated by chemonucleolysis underwent surgery within 8 weeks. At 1 year, 10 to 13 years, and 24 to 27 years, 94%, 72%, and 63% of patients treated by chemonucleolysis had good or excellent results compared with 96%, 72%, and 67% of patients who underwent surgery, respectively. There was no difference in the clinical outcome between the treatments at any of the follow-up time points. There were 2 serious complications, 1in each treatment group. CONCLUSION: Chemonucleolysis is as effective as surgery when assessed according to intention-to-treat analysis, with reduced complications, and age has no bearing on the outcome. The authors think that restoration of its availability would be beneficial to patients. LEVEL OF EVIDENCE: 1.

[Chemonucleolysis and intradiscal electrothermal therapy: what is the current evidence?]. / Chemonukleolyse und intradiskale Elektrotherapie: was ist die gegenwärtige Evidenz?

We evaluated the efficacy and safety of chemonucleolysis and intradiscal electrothermal therapy (IDET) on the basis of the data presented in recently published papers with respect to pain relief, function, and complication rates. Detailed searches for English and German articles published between 2003 and 2008 were performed in a number of electronic databases. Further publications were identified by manual search. For summarizing the evidence, we considered only systematic reviews and controlled studies. The internal validity of reviews and studies was judged by two authors independently. Data extraction was performed by one author, and the extracted data was checked for completeness and correctness by a second author. The evidence of the efficacy of chemonucleolysis using chymopapain or collagenase is summarized in two recent, high-quality systematic reviews. We found 5 controlled studies evaluating nucleolysis using an oxygen-ozone mixture (O (2)O (3)-nucleolysis). Some of those studies were of limited methodological quality, but all showed the efficacy of O (2)O (3)-nucleolysis in comparison to microdiscectomy or the use of alternative substances. There is hardly any data regarding O (2)O (3)-nucleolysis complications. Regarding IDET, the authors of the 6 identified systematic reviews come to different conclusions about the efficacy of the procedure. The results of the 3 included controlled IDET studies, of which 2 are of high methodological quality, are also conflicting. The complication rates range from 0 to 15 %. In summary, the evidence of efficacy is presently more compelling for chemonucleolysis than for IDET. This may also be because indications for chemonucleolysis are more firmly established. However, safety aspects should be better evaluated and presented in the literature.

A pyogenic discitis at c3-c4 with associated ventral epidural abscess involving c1-c4 after intradiscal oxygen-ozone chemonucleolysis: a case report.

STUDY DESIGN: A case report and clinical discussion. OBJECTIVE: To describe an unique case of purulent discitis at C3-C4 and an anterior C1-C4 epidural abscess secondary to oxygen-ozone therapy for the herniated cervical discs. SUMMARY OF BACKGROUND DATA: Previously reported complications secondary to ozone therapy are rarely documented. No cases of pyogenic discitis with associated epidural abscess after oxygen-ozone therapy have been reported to date. To our knowledge, this is the first such case reported in literature. METHODS: A 57-year-old female patient with nuchal stiffness was previously treated with ozone therapy at the discs of C3-C4, C4-C5, and C6-C7. Five days later, she presented with an attack of neck pain and fever followed by progressive quadriplegia with sudden onset of dyspnea and was referred to our hospital. On admission, physical examination revealed a temperature of 38.8 degrees C, evident neck tenderness, marked global weakness (grade 1-2/5 MRC) in bilateral upper-limb, and a modest global weakness in bilateral lower-limb (grade 4/5 MRC). Laboratory findings showed a significantly elevated WCC, ESR, and CRP. Blood culture was negative. Enhanced-MR imaging demonstrated a purulent discitis at C3-C4 and a ventral C1-C4 epidural abscess with homogenous enhancement indicative of a solid phlegmonous granulation tissue. RESULTS: We formulated a 3-stage treatment involving C1-C4 multilevel decompressive laminectomies, subtotal unilateral C3-C4 facetectomies, and tissue sampling for culture with application of a corset after surgery, followed by a delayed secondary posterior thorough drainage of epidural liquid pus using a suction-irrigation drainage, after the abscess had turned to a necrotic liquid abscess, on the basis of findings of enhanced-MR imaging, by 10-day duration of intravenously antibiotic therapy tailored to Streptococcus bovis isolated from infected tissue. Over the next few weeks, the patient made an excellent neurologic recovery. However, she did not consent to undergo further occipitocervical fusion until the follow-up MR imaging at 8 months demonstrated postlaminectomy kyphosis. After surgery, the patient remained clinically satisfactory in neurology without evidence of a recurrence of spinal infection. A slight improvement in the cervical spine curve was demonstrated in the follow-up radiograph at nearly 4-month postoccipitocervical fusion. CONCLUSION: This case report illustrates a rare but life-threatening complication of oxygen-ozone therapy for the cervical disc herniation. Infection is a common risk for any invasive spinal techniques involving puncture, so attention should be paid to the sterility during the procedures. A high index of suspicion along with reliance on enhanced-MRI is essential to diagnose the condition and institute appropriate treatment on an individual basis.

[Long-term 10-year outcome after chemonucleolysis for lumbar disc herniation]. / Résultats à long terme de la chimionucléolyse pour hernie discale lombaire.

PURPOSE OF THE STUDY: We studied the efficacy of papaine for treatment of herniated discs at a mean 10-year follow-up and compared results with other series and other treatments. MATERIAL AND METHODS: From an initial group of 160 patients, 96 patients, 53 men and 43 women, mean age 39 years, were selected for evaluation. These patients had 46 L4L5 herniations and 50 L5S1 herniations. All 96 patients were operated in the same department and received the same dose of papaine under the same anesthesia conditions. All patients were followed regularly to 3 months postoperatively then were reviewed 3 to 17 years after surgery. Inquiries were made about return to work, pain, and activity. Physical examination and x-rays were obtained for all patients. RESULTS: There were no neurological complications in our series. Seventeen patients required a second procedure for sciatic pain. Most of the patients continued their normal occupational and social activities after papaine treatment, but many of them had chronic lumbar pain. DISCUSSION: Our results were comparable with series reporting a similar long follow-up. Surgery is more efficient than papaine but long-term results are equivalent. CONCLUSION: Chemopapaine treatment provided good long-term results in our patients, similar to surgery. Chemonucleolysis may be employed as first line treatment for young patients with non-excluded disc herniation with sciatic pain.

Review of safety in endoscopic laser foraminoplasty for the management of back pain.

OBJECTIVE: The purpose of this study was to analyze the incidence and gravity of reported complications that arise in spinal surgery and assess the comparative safety, or otherwise, of endoscopic laser foraminoplasty (ELF). BACKGROUND DATA: Chemonucleolysis, decompression, discectomy, and fusion have long been cited as treatments for chronic low back pain. Over recent years newer, less invasive surgical techniques have become available, one such being ELF. Although minimally invasive, the beneficial outcome must be interpreted in relation to concerns regarding the safety of the procedure and its risks relative to those of other forms of spinal surgery. The Spinal Foundation, Rochdale has performed 958 ELFs and has collated a comprehensive database of the results of all these operations. These prospective records provided the basis for a comparison of the safety of ELF to that reported with other spinal surgical techniques. METHODS: A total of 958 procedures have been performed on 716 patients. Complications that arose during the operation and the postoperative phase of 6 weeks following the procedure were elicited from patient records. These data were correlated and compared to a meta-analysis of randomized controlled clinical trial data of complications arising during and after conventional spinal surgery. The SPSS (statistical package for social sciences) and CIA (confidence interval analysis) statistical packages were used to draw conclusions regarding the safety of ELF. RESULTS: The cohort integrity of operation and outpatient review records at 6 weeks after surgery was 100%. In 958 ELFs performed, 24 complications occurred in 23 patients. There were 9 cases of discitis (1 infective, 8 aseptic) (0.9%), 1 dural tear (0.1%), 1 deep wound infection (0.1%), 2 patients suffered a foot drop (1 transient) (0.2%), 1 myocardial infarction (0.1%), 1 erectile dysfunction (0.1%), and 1 patient who developed panic attacks post-operatively (0.1%). This amounts to an overall surgical complication rate of 1.6%. Magnetic resonance imaging (MRI) follow up of clinically symptomatic patients highlighted 8 residual disc herniations (0.8%). Meta-analysis of randomized controlled trials of conventional spinal surgery for adult onset degenerative disc disease and/or sciatic pain reported overall complication rates for fusion (11.8%), decompression (7.6%), discectomy (6.0%), and chemonucleolysis (9.6%). CONCLUSIONS: The complication rate of ELF is shown to be significantly lower than that reported following conventional spinal surgery (p < 0.01). From these results, we conclude that ELF as a treatment for chronic low back pain and sciatica presents less risk to a patient than conventional methods of spinal surgery.

Chemonucleolysis: the state of the art.

This review presents the history of chemonucleolysis, the techniques, indications, contraindications, and complications. Presenting an historical overview and comparison of success rates with surgical discectomy may provide a fresh understanding of the controversy surrounding chemonucleolysis and establish its efficacy in relation to more invasive treatments. A review of the literature from 1973 through 1998 for chemonucleolysis, open discectomy, and microdiscectomy provided published success rates for these procedures, and a mean rate with standard deviation was determined. In the experience and opinion of the authors, chemonucleolysis remains a viable alternative for patients who have exhausted all conservative means of treatment. Proper patient selection leads to success rates comparable to open discectomy and microdiscectomy.

[Late myelopathy after chemonucleolysis. Case report and review of the literature]. / Spätmyelopathie nach Chemonukleolyse. Fallbericht und Ubersicht über die Literatur.

Chemonucleolysis is a debated therapeutic method for herniated lumbar disc. We report a patient who suffered a sequence of characteristic sequels cumulating in late-onset myelopathy with persistent spastic paraplegia, sensory loss below T8 and bladder incontinence. Complications of chemonucleolysis are less frequent as compared to herniated disc surgery, but may cause severe impediment. Serious complications are anaphylactic shock, intracranial or spinal hemorrhage and transverse myelitis. This has to be taken into account for indication and patient information.

[2 cases of iatrogenic oral streptococcal infection: meningitis and spondylodiscitis]. / Deux observations d'infections iatrogènes à streptocoques oraux: méningite et spondylodiscite.

INTRODUCTION: The multiplication of invasive spine investigations for either diagnostic or therapeutical purposes increases the risk for iatrogenic infections. We report two cases of iatrogenic infections, one case of meningitidis and one case of spondylodiscitis due to Streptococcus viridans. EXEGESIS: The two cases included a 42-year-old male patient presenting with spondylodiscitis due to Streptococcus oralis following nucleolysis for discal node and a 51-year-old female patient with purulent meningitidis due to Streptococcus salivarius following hysteroscopy with spinal anesthesia. According to the disease chronology and bacterial results, iatrogenesis was evidenced. The streptococci originate from the patient's skin or from the operators' endobuccal flora. CONCLUSION: Simple aseptic rules, including wearing a surgical mask during any spinal tap, would definitely avoid iatrogenic infections.

[Chemonucleolysis of lumbar disk prolapse. Choice and complications]. / Kjemonukleolyse av lumbale skiveprolapser. Utvelgelse og komplikasjoner.

Chemonucleolysis with chymopapain is a well-documented method of treating lumbar disc herniation. In spite of this, only few patients are treated in this way in Norway. We have offered selected patients chemonucleolysis at our hospital since 1985. This article reports the long-term outcomes as regards employment status, back pain and leg pain. We have treated 277 patients. 269 were still alive in October 1995 and were sent a follow-up questionnaire. 257 patients responded, of whom 36 (14%) had undergone surgery later, due to an unsatisfactory outcome of chemonucleolysis. 72% of the patients were fully employed at the time of follow-up. 61% had little or no back pain, while 69% never or only rarely suffered pain in the leg.

[Neurosurgical treatment of complications of intra-disk injections of triamcinolone hexacetonide. Value of a radio-clinical classification]. / Traitement neurochirurgical des complications des nucléorthèses à l'hexacétonide de triamcinolone. Intérêt d'une classification radio-clinique.

Epidural granulomas following intra-discal injection of triamcinolone hexacetonide are a well-known complication of this procedure, which is still encountered, even if its utilization was discontinued several years ago. According to the results of their experience, the authors propose a new radio-clinical grading system: grade I: disc calcification with aspect of "sub-ligamentar hernia" on CT scan; grade II: ascendant or descendant retrosomatic migration of distal content; grade III: pseudotumoral epidural infiltrate producing progressive narrowing of the spinal canal with neurological disturbance. Surgical indications in these cases can be drawn from their evolution: posterior approach can be used, with or without laminectomy, for excision as complete as possible of the involved disc (grades I and II); anterior approach should be preferred in cases of multiples recurrences after medical treatment and failure of classical posterior approach, or in case of necrotico-inflammatory proliferation with narrowing of the spinal canal (grade III).

Chemonucleolysis.

Even with a history of controversy and troubling complications, chymopapain has endured the test of time to show 30 years of clinical success in the treatment of herniated nucleus pulposus. Strict attention to indications, contraindications, and technique ensures safety and efficacy of treatment. A trend to decreased dosage may result in less postinjection spasm. Between 1982-1991, 121 adverse events in 135,000 patients were reported to the Food and Drug Administration and investigated. Seven cases of fatal anaphylaxis, 24 infections, 32 bleeding problems, 32 neurologic events, and 15 miscellaneous occurrences were found. Overall mortality rate was 0.019%. All categories were of lesser incidence than complications with laminectomy. Long-term results show that improvement after chemonucleolysis is maintained, whereas the outcome after laminectomy is reported to deteriorate with time. Cost savings with chemonucleolysis over laminectomy are largely a matter of shorter hospitalization. A protocol for cervical chemonucleolysis is being developed in the United States after good results have been shown in Spain and France. Other enzymes continue under investigation, but chymopapain remains the standard to which they are compared.

[20 years of lumbar chymonucleolysis]. / Vingt ans de chymonucléolyse lombaire.

If correct indications and rigorous technique are applied, nucleolysis with chymopapain can be an effective cure for herniated nucleus pulposus in patients who do not respond to adequate medical treatment. Pain relief is obtained in approximately 75% of the patients. In case of failure, secondary surgery may be proposed with a success rate similar to primary surgery. The risk of complications is lower than for surgery. Initial satisfactory results are usually maintained at long term. The main inconveniences include a possible painful reaction in 30-40% of the patients and in certain cases progressives rather than rapid pain relief. Cost analysis shows a 40% gain over surgery. After 20 years of experience, chemonucleolysis for herniated nucleus pulposus has been shown to be an effective therapeutic technique which should be part of an overall management strategy including medical treatment and surgery.