Treatment Gaps and Emerging Therapies in Lumbar Disc Herniation.

BACKGROUND: Lumbar disc herniation (LDH) occurs when the central disc material, primarily the nucleus pulposus, is displaced beyond the outer annulus, compressing the spinal nerve roots. LDH symptoms, including radicular leg pain, radiculopathy, and low back pain, are associated with considerable disease burden and the significant utilization of health care resources. OBJECTIVES: Provide overview of the current treatment landscape for LDH, identify unmet needs, and describe emerging treatments. STUDY DESIGN: Narrative literature review. METHODS: A review of literature concerning available LDH treatments and associated outcomes was conducted in PubMed to identify areas of unmet need. Some key words included "lumbar disc herniation," "radicular leg pain," "sciatica," "treatment," "therapy," and "burden." RESULTS: For patients who do not respond to conservative therapy, epidural steroid injections (ESIs) are widely used for persistent LDH symptoms. While ESIs provide short-term improvements in radicular pain, evidence that ESIs bestow sustained benefits is limited. ESIs are not approved by the US Food and Drug Administration (FDA) and, in rare cases, carry risks of infection and neurological injury, as well as the potential for long-term systemic effects of glucocorticoids. In cases when nonsurgical treatment fails to relieve symptoms, lumbar discectomy can provide rapid pain relief; however, in addition to the risk of intraoperative complications, the long-term consequences of lumbar discectomy may include recurrent pain or herniation, revision discectomy, loss of disc height, and Modic changes. Treatments for LDH in late-stage clinical development include sustained-release ESI formulations and a novel agent for chemonucleolysis, a nonsurgical method of minimizing the volume of the displaced nucleus pulposus. Emerging minimally invasive therapies that address the underlying pathophysiology of the disease have the potential to bridge the gap between symptomatic treatments and surgery. LIMITATIONS: Because this paper was a narrative review, literature search and selection processes were not systematic in nature. The evidence regarding the long-term efficacy of some treatments, such as discectomy, was limited by the high rates of crossover between the treatment groups. CONCLUSIONS: The lack of sustained benefits associated with ESIs and the risks associated with surgery underscore the unmet need for novel, minimally invasive interventional therapies able to address the underlying nerve root compression in LDH.

Percutaneous Intradiscal Radiofrequency Thermocoagulation Combined with Sinuvertebral Nerve Ablation for the Treatment of Discogenic Low Back Pain.

BACKGROUND: Percutaneous intervertebral radiofrequency thermocoagulation (PIRFT) and sinuvertebral nerve ablation (SVNA) are commonly used clinical treatments for discogenic low back pain (DLBP). However, they have been reported to have low efficacy rates of approximately 16.5%-26.5%, especially in the medium to long term. OBJECTIVES: To investigate whether PIRFT combined with SVNA can reduce pain and improve clinical outcomes in patients with DLBP. STUDY DESIGN: This is a prospective study. SETTING: All data were from Honghui Hospital in Xi'an. METHODS: Following the inclusion and exclusion criteria, 195 patients were enrolled in this study and randomly divided into 3 groups of 65 patients each and treated with PIRFT+SVNA, PIRFT, or SVNA. Postoperative follow-ups were done at one week, one month, 3 months, 6 months, and 12 months. The demographic characteristics, relevant surgical information, and observed complications of all groups were recorded. The efficacy of the surgeries was evaluated using the visual analog scale (VAS), Oswestry disability index (ODI), and modified Macnab criteria. RESULTS: In total, 167 patients, comprising 81 men and 86 women (aged 28-75 years), were included in this study and completed postoperative follow-ups. There were 54 patients in the combined PIRFT and SVNA (PIRFT+SVNA) group, 58 patients in the PIRFT group, and 55 patients in the SVNA group. All groups were comparable because there were no significant differences in gender, age, disease duration, follow-up time, surgical segments and presence of high-intensity zones of the groups (P > 0.05). In addition, the efficacy of the PIRFT+SVNA group was significantly higher than that of the PIRFT and SVNA groups as assessed by the modified Macnab criteria (P = 0.032). Surgery was successfully completed in all 3 groups, and VAS and ODI improved at all postoperative time points in all 3 groups compared to the preoperative scores. The differences between the VAS and ODI scores preoperation and 12 months postoperation were not statistically significant between all 3 groups. However, at one week, one month, 3 months, and 6 months after surgery, the VAS and ODI scores were lower in the PIRFT+SVNA group compared to the PIRFT and SVNA groups. The difference in VAS scores among the 3 groups was most significant at one week postoperation, and the difference in ODI scores was most significant at one month postoperation. The VAS and ODI improvement rates of the 3 groups showed significant improvement at one week, one month, 3 months, and 6 months postoperation (P < 0.05). There was no significant difference among the 3 groups at 12 months postoperation (P > 0.05). LIMITATIONS: This study was limited by its small sample size in a single-center study. CONCLUSIONS: In DLBP, the sinuvertebral nerve (SVN) is the main nerve involved in the lumbar disc pain signaling pathway, and compared with PIRFT and SVNA alone, combined PIRFT and SVNA treatment may provide more satisfactory pain relief and functional improvement at an early stage.

"Advancements in minimally invasive treatment for lumbar disc herniation: insights into condoliase and chondroitin sulfate ABC endolyase".

This study examines the efficacy and safety of condoliase chemonucleolysis (CC) in treating lumbar disc herniation (LDH) and highlights emerging alternatives like chondroitin sulfate ABC endolyase. Research indicates that condoliase, an enzyme used to degrade glycosaminoglycans in the nucleus pulposus, provides effective and prompt relief of leg pain, with significant reductions observed within a day of treatment. Studies reveal that a lower pretreatment straight leg raising (SLR) angle may predict early symptom relief, and condoliase is generally effective at doses up to 1.25 U, balancing efficacy and safety. Despite promising results, concerns about long-term safety, including disc height reduction and imaging changes, persist. Additionally, chondroitin sulfate ABC endolyase shows potential as a safer and more effective alternative, though further research is needed to optimize treatment protocols and assess long-term outcomes. Future investigations should address current limitations, such as small sample sizes and short follow-up periods, to better understand the long-term benefits and risks of these treatments.

Indication and Limitation of Intradiscal Condoliase Injection for Patients with Lumbar Disc Herniation: Literature Review and Meta-Analysis.

Background: Intradiscal condoliase injection for lumbar disc herniation (LDH) was developed in Japan in 2018. The treatment is intermediate between conservative therapy and surgery, and its frequency is increasing. Condoliase is limited to a single application over a lifetime, rendering it important to understand the indications and predictors of its effectiveness. This review aimed to summarize published studies and provide appropriate indications and limitations for appropriate patient selection based on existing findings. Methods: While adhering to PRISMA guidelines, we searched the PubMed, Web of Science, and EMBASE databases to identify articles reporting the clinical outcomes of intradiscal condoliase injection for LDH. Data extraction focused on the effective rate, prognostic factors, and posttreatment imaging changes and was used in the meta-analysis. Results: Nineteen studies met the inclusion criteria. Our meta-analysis revealed 78% total response, 11% posttreatment surgery, and 42% posttreatment Pfirrmann-classification-grade progression rates. Posttreatment intervertebral disc degeneration was potentially associated with an improved response rate and disc regeneration one year posttreatment, especially in young patients. The Regimen for patients aged <20 and >70 years should be carefully selected, including those with a disease duration of >1 year, recurrent LDH, small-sized LDH, vertebral instability, and inadequate duration (<3 months) of conservative therapy. Conclusions: Although long-term outcomes and imaging changes must be evaluated owing to the heterogeneity of previous studies, intradiscal condoliase injection is a minimally invasive and cost-effective treatment option for patients with LDH. Treatment indications should be determined after carefully evaluating evidence from previous conservative and surgical treatments.

A phase 3, randomized, double-blind, sham-controlled trial of SI-6603 (condoliase) in patients with radicular leg pain associated with lumbar disc herniation.

BACKGROUND CONTEXT: SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH. PURPOSE: The Discover 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH. STUDY DESIGN/SETTING: A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States. PATIENT SAMPLE: Male and female participants (N=352; aged 30-70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks. OUTCOME MEASURES: The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings. METHODS: Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery. RESULTS: Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: -41.7) compared with sham injection (-34.2; LSM difference: -7.5; 95% confidence interval [CI]: -14.1, -0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred. CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.

Ozone Disc Nucleolysis for Cervical Intervertebral Disc Herniation: A Systematic Review and Meta-Analysis.

Cervical intervertebral disc herniation is a common condition and most often presents as neck or upper limb pain causing varying levels of disability and dysfunction. Percutaneous injection of ozone into the intradiscal space is a novel and minimally invasive technique for managing this condition and can be an effective alternative to surgical management. A literature search was done using the keywords ozone disc nucleolysis of cervical intervertebral lesions, and five studies were selected based on the inclusion and exclusion criteria. Meta-analysis was performed to determine safety, effectiveness, and symptomatic relief (determined based on the visual analog scale (VAS)) with the publication bias being removed. Subjects treated with ozone therapy showed significant reduction (p < 0.0001) in VAS score as compared to baseline VAS score with a standardized mean difference of 2.78 (95% CI = 1.48 to 4.07; Z value = 4.20). Ozone nucleolysis is a minimally invasive, relatively safe, and optimally effective treatment option for reducing the pain related to cervical disc. Intradiscal ozone therapy can be considered an alternative treatment modality, and well-designed, randomized clinical trials are required to confirm the long-term superiority of ozone therapy against other treatment modalities available for cervical disc herniation.

Experimental Study of Failures of the Rigid Spinal Posterior Fixation System Under Compressive Load Conditions: A Cadaver Study.

Background Many studies have been conducted on the biomechanics of the spine to elucidate the fixation properties of spinal fusion surgery and the causes of instrumentation failure. Among these studies, there are some studies on load sharing in the spine and measurement using strain gauges and pressure gauges, but there is a lack of research on axial compressive loads. Methods Axial compressive load tests were performed on human cadaveric injured lumbar vertebrae fixed with pedicle screws (PS). Both the strain generated in the PS rod and the intradiscal pressure were measured. Subsequently, the stress generated in the PS rod and the load sharing of the spine and instrumentation were calculated. Results Even when only compressive load is applied, bending stress of more than 10 times the compression stress was generated in the rod, and the stress tended to concentrate on one rod. Rod deformation becomes kyphotic, in contrast to the lordotic deformation behavior of the lumbar spine. The stress shielding rate was approximately 40%, less than half. Conclusions This study obtained basic data useful for constructing and verifying numerical simulations that are effective for predicting and elucidating the causes of dislodgement and failure of spinal implants.

Perspective on Intradiscal Therapies for Lumbar Discogenic Pain: State of the Science, Knowledge Gaps, and Imperatives for Clinical Adoption.

Specific clinical diagnostic criteria have established a consensus for defining patients with lumbar discogenic pain. However, if conservative medical management fails, these patients have few treatment options short of surgery involving discectomy often coupled with fusion or arthroplasty. There is a rapidly-emerging research effort to fill this treatment gap with intradiscal therapies that can be delivered minimally-invasively via fluoroscopically guided injection without altering the normal anatomy of the affected vertebral motion segment. Viable candidate products to date have included mesenchymal stromal cells, platelet-rich plasma, nucleus pulposus structural allograft, and other cell-based compositions. The objective of these products is to repair, supplement, and restore the damaged intervertebral disc as well as retard further degeneration. In doing so, the intervention is meant to eliminate the source of discogenic pain and avoid surgery. Methodologically rigorous studies are rare, however, and based on the best clinical evidence, the safety as well as the magnitude and duration of clinical efficacy remain difficult to estimate. Further, we summarize the US Food and Drug Administration's (FDA) guidance regarding the interpretation of the minimal manipulation and homologous use criteria, which is central to designating these products as a tissue or as a drug/device/biologic. We also provide perspectives on the core evidence and knowledge gaps associated with intradiscal therapies, propose imperatives for evaluating effectiveness of these treatments and highlight several new technologies on the horizon.

The Safety and Effectiveness of Orthobiologic Injections for Discogenic Chronic Low Back Pain: A Multicenter Prospective, Crossover, Randomized Controlled Trial with 12 Months Follow-up.

BACKGROUND: Chronic low back pain is one of the most common causes of disability, affecting more than 600 million people worldwide with major social and economic costs. Current treatment options include conservative, surgical, and minimally invasive interventional treatment approaches. Novel therapeutic treatment options continue to develop, targeting the biological cascades involved in the degenerative processes to prevent invasive spinal surgical procedures. Both intradiscal platelet-rich plasma (PRP) and bone marrow concentrate (BMC) applications have been introduced as promising regenerative treatment procedures. OBJECTIVES: The primary objective of this study is to assess the safety and effectiveness of an orthobiologic intradiscal injection, PRP or BMC, when compared to control patients. The secondary objectives are to measure: patient satisfaction and incidence of hospitalization, emergency room visit and spine surgery at predetermined follow-up intervals. STUDY DESIGN: A multicenter, prospective, crossover, randomized, controlled trial. SETTING: Comprehensive Spine and Sports Center and participating centers. METHODS: Forty patients were randomized into saline trigger point injection, intradiscal PRP, or BMC. Follow-up was 1, 3, 6, and 12 months posttreatment. Placebo patients were randomized to PRP and BMC injection if < 50% decrease in numeric rating scale (NRS) scores in 3 months, while PRP and BMC patients to the other active group if < 50% decrease in NRS scores in 6 months. RESULTS: Both PRP and BMC demonstrated statistically significant improvement in pain and function. All the placebo patients reported < 50% pain relief and crossed to the active arm. None of the patients had any adverse effects, hospitalization, or surgery up to 12 months posttreatment. LIMITATIONS: The limitations of our study were the small number of patients and open-label nature of the study. CONCLUSION: This is the only human lumbar disc study that evaluates both PRP and BMC in the same study and compares it to placebo. PRP and BMC were found to be superior to placebo in improving pain and function; however, larger randomized clinical trials are needed to answer further questions on the comparative effectiveness of various biologics as well as to identify outcome differences specific to disc pathology.

Mesenchymal stem cells and thermal annular procedures for discogenic pain: a systematic review with pooled analysis.

Aim: Compare the effectiveness of mesenchymal stem cell injection therapies (MSC) and thermal annular procedures for the treatment of discogenic lower back pain. Materials & methods: A systematic review was performed following PRISMA 2020 guidelines. Pooled analysis was performed using patients' pain scores at baseline and at 12 months post-intervention. Results: Effect sizes based on change in pain score from baseline to 12 month follow-up revealed clinically significant improvement in pain score across all interventions. Conclusion: Minimally invasive interventions provide meaningful relief in discogenic back pain, with results suggesting promise for MSC injection therapies as a treatment model.

Regenerative effects of platelet-rich plasma releasate injection in rabbit discs degenerated by intradiscal injection of condoliase.

BACKGROUND: Intradiscal condoliase injection is an alternative therapeutic option for lumbar disc herniation (LDH). However, it is often associated with disc degeneration. Several in vivo studies have demonstrated the regenerative potential of platelet-rich plasma (PRP) in disc degeneration. Thus, we hypothesized that the intradiscal injection of PRP releasate (PRPr), a soluble releasate isolated from PRP, has the potential to regenerate degenerated intervertebral discs (IVDs) induced by condoliase. This study examined the regenerative effects of PRPr on rabbit IVDs degenerated following condoliase injection. METHODS: Eleven New Zealand white rabbits were used in this study. Condoliase (12.5 mU/10 µl) was injected into two non-contiguous discs (L2-L3 and L4-L5), and L3-L4 disc was left intact as a non-injection control. Saline (20 µl) or PRPr (20 µl) was randomly injected into L2-L3 and L4-L5 discs 4 weeks after the condoliase injection. Disc height (DH) was radiographically monitored biweekly from the day of condoliase injection to 16 weeks post-injection. Changes in DH were expressed as percentage DH (%DH) normalized to the baseline DH. Sixteen weeks after condoliase injection, all rabbits were euthanized, and subjected to MRI and histological analyses. RESULTS: Intradiscal injection of condoliase induced a significant decrease in %DH (L2-L3 and L4-L5) to 52.0% at week 4. However, the %DH began to return to normal after saline injection and reached 76.3% at week 16. In the PRPr group, %DH began to recover to normal after the PRPr injection and was restored to 95.5% at week 16. The MRI-modified Pfirrmann grade of the PRPr group was significantly lower than that of the saline group (P < 0.01). Histological analyses showed progressive degenerative changes, including reduction of the NP area and condensation of the matrix in the saline and PRPr groups. The histological score of the PRPr group was significantly lower than that of the saline group (P < 0.01). CONCLUSIONS: PRPr has great potential to enhance the regeneration of degenerated rabbit IVDs induced by condoliase. The results of this preclinical study suggest that PRPr injection therapy may be indicated for patients with LDH who have poor recovery from disc degeneration after chemonucleolysis treatment with condoliase.

Ligamentous tethering and intradiscal pressure affecting the mechanical environment of scoliotic spines.

Despite several theories have been proposed to explain the progression of Adolescent Idiopathic Scoliosis (AIS), there is no consensus on the mechanical factors that control the spinal deformities. Prominent biomechanical notions focus on the geometrical asymmetry and differential growth, however, the correlation between these phenomena remains unclear. We postulate that intradiscal pressure and its connection with the supporting ligamentous structures are the reasons behind the asymmetric growth in AIS. To investigate this hypothesis, a numerical 3D patient-specific model of a scoliotic spine is constructed to carry upper body weight. Four analyses are performed: control simulation with no ligaments followed by 3 simulations, in each, a different and stiffer set of ligaments is employed. The analyses showed that intradiscal pressure is relatively high in the spine's higher-deformity region. Moreover, the stiffness effect of the ligamentous tethering correlated directly to intradiscal pressure; the stiffer the ligaments, the higher the intradiscal pressure. Due to geometrical asymmetry, the pressure is eccentric toward the concave region of deformed vertebral units. As a result, the deformed annulus fibrosus generated uplifts in the convex side of deformed vertebral units. The eccentric pressure and the uplift are opposite in location and direction creating an imbalanced mechanical environment for the spine during growth.

An Analysis of the Clinical and Radiological Prognostic Factors Affecting the Outcomes of Lumbar Intradiscal Biacuplasty.

Purpose: Intradiscal biacuplasty (IDB) has been proven to be effective for treating lumbar degenerative disc disease (DDD). However, there has not been a reported prognostic factor for IDB. The present study meticulously evaluates the general and radiographic features that may serve as markers for predicting the therapeutic outcome of IDB. Methods: A prospective case series study was conducted, following time-series analysis moving averages models, with forty-one patients suffering from chronic discogenic lower back pain for more than six months. These patients subsequently received lumbar cool radiofrequency IDB and were enrolled in the study. Thirty-seven patients completed follow-up questionnaires at 1, 3, 6, and 12 months. The surgical outcomes were reported using visual analogue scale (VAS), Oswestry disability index (ODI), and the consumption of nonsteroidal anti-inflammatory drugs (NSAID). Furthermore, a univariate analysis was performed to identify prognostic factors associated with pain relief from age, gender, body mass index (BMI), and pre-operative lumbar magnetic resonance imaging reading. Results: Significant reductions were found in estimated VAS and ODI at the post-operative period at 1, 3, 6, and 12 months (P < 0.001). The NSAID dosage was significantly decreased at 3-month and 1-year follow-up (P < 0.05). No procedure-related complications were detected. The prognosis of IDB was not related to disc height, Pfirrmann grading or Modic endplate change. However, disc extrusions were associated with promising outcomes (VAS improvement ≥ 50%) on pain relief (P < 0.05). Conclusion: IDB is a good alternative choice for treating lumbar DDD. Patients with a painful extrusion lumbar disc may gain some benefits after receiving IDB following a period of failed conservative treatment. These findings may also add some references for physicians in the decision making when treating lumbar DDD.

Stem cells and discogenic back pain.

BACKGROUND: Chronic low back pain, common from the sixth decade, negatively impacts the quality of life of patients and health care systems. Recently, mesenchymal stem cells (MSCs) have been introduced in the management of degenerative discogenic pain. The present study summarizes the current knowledge on the effectiveness of MSCs in patients with discogenic back pain. SOURCES OF DATA: We performed a systematic review of the literature following the PRISMA guidelines. We searched PubMed and Google Scholar database, and identified 14 articles about management of chronic low back pain with MSCs injection therapy. We recorded information on type of stem cells employed, culture medium, clinical scores and MRI outcomes. AREAS OF AGREEMENT: We identified a total of 303 patients. Ten studies used bone marrow stem cells. In the other four studies, different stem cells were used (of adipose, umbilical, or chondrocytic origin and a pre-packaged product). The most commonly used scores were Visual Analogue Scale and Oswestry Disability Index. AREAS OF CONTROVERSY: There are few studies with many missing data. GROWING POINTS: The studies analysed demonstrate that intradiscal injections of MSCs are effective on discogenic low-back pain. This effect may result from inhibition of nociceptors, reduction of catabolism and repair of injured or degenerated tissues. AREAS TIMELY FOR DEVELOPING RESEARCH: Further research should define the most effective procedure, trying to standardize a single method.

Retrospective Analysis of Factors Associated with the Treatment Outcomes of Intradiscal Platelet-Rich Plasma-Releasate Injection Therapy for Patients with Discogenic Low Back Pain.

Background and Objectives: Recently, the clinical application of platelet-rich plasma (PRP) has gained popularity for the treatment of degenerative disc diseases. However, the regenerative effects and factors associated with treatment outcomes after intradiscal injection of PRP remain unknown. This study aimed to evaluate time-dependent changes in imaging findings related to intervertebral disc (IVD) degeneration and to identify factors associated with the outcomes of PRP injection therapy. Materials and Methods: A retrospective analysis of a previous randomized clinical trial of intradiscal injection of the releasate isolated from PRP (PRPr) in patients with discogenic low back pain (LBP) was performed. Radiographic parameters (segmental angulation and lumbar lordosis) and MRI phenotypes, including Modic changes, disc bulge, and high-intensity zones (HIZs), were evaluated at baseline and 6 and 12 months post-injection. Treatment outcomes were evaluated based on the degree of LBP and LBP-related disability at 12 months post-injection. Results: A total of 15 patients (mean age: 33.9 ± 9.5 years) were included in this study. Radiographic parameters showed no significant changes after the PRPr injection. There were no remarkable changes in the prevalence or type of MRI phenotype. Treatment outcomes were significantly improved after treatment; however, the number of targeted discs and the presence of posterior HIZs at baseline were significantly but negatively associated with treatment outcomes. Conclusions: Intradiscal injection of PRPr significantly improved LBP and LBP-related disability 12 months post-injection; however, patients with multiple target lesions or posterior HIZs at baseline were significantly associated with poor treatment outcomes.

Progress in Discography.

Discography is an important method for diagnosing discogenic low back pain (LBP) and replicating the effects of pain. However, its development is not smooth due to its safety and reliability, which have not been completely confirmed. Beginning with the clinicians using discography, there remains constant controversy. With the continuous progress of related research on discography, clinicians and scholars' understanding of discography is constantly improving. This article reviews the background, clinical application, and safety of discography.

Testicular pain originating from lumbar disc degeneration: A case report.

BACKGROUND: Testicular pain caused by lumbar disease is uncommon in the clinic. Here we reported a case of discogenic low back pain with testicular pain that was successfully cured. CASE SUMMARY: A 23-year-old male patient presented to our department with chronic low back pain. Based on his clinical symptoms, signs and imaging, he was diagnosed with discogenic low back pain. Since conservative treatment for more than half a year did not significantly improve his low back pain, we decided to treat it with intradiscal methylene blue injection. During the course of surgery, we again identified the low back pain as originating from the degenerated lumbar disc by analgesic discography. Interestingly, the patient's low back pain disappeared along with the testicular pain that had been present for more than 3 mo. After the operation, the patient's low back pain improved, and the testicular pain did not reappear. CONCLUSION: Intradiscal methylene blue injection is a convenient and effective surgical intervention for the treatment of discogenic low back pain. Lumbar disc degeneration may also be a possible clinical cause of testicular pain. Methylene blue injection in the diseased disc improved the low back pain, and the accompanying testicular pain was successfully managed.

Outcomes of C-arm cone-beam CT-guided percutaneous procedures for thoracolumbar spondylodiscitis: a comparison between with and without intradiscal drainage.

INTRODUCTION: Percutaneous intradiscal drainage had little established evidence to date. We assessed the outcomes of C-arm cone-beam CT-guided (CBCT-guided) procedures for spondylodiscitis and compare procedures with and without intradiscal drainage. MATERIAL AND METHODS: A retrospective review was conducted on patients who underwent CBCT-guided procedures for spondylodiscitis with fluid collection in the intradiscal space between January 2010 and September 2021. Included patients were divided into two groups: with and without 'intradiscal drainage' (ID and non-ID, respectively). RESULTS: A total of 87 patients with thoracolumbar discitis (mean age 73.4 ± 12.3 years, 35 females) were included. There was no significant difference in clinical outcomes between groups. Although insignificant, a subgroup analysis of patients with discitis and psoas abscess showed a higher infection control success rate (81% (17/21) vs 58% (7/12), p = .23) and faster median C-reactive protein improvement (CRP <3 mg/dL: 12 vs 42 days, p = .11, CRP <1 mg/dL: 27 vs 45 days, p = .097) of ID than of non-ID. CONCLUSIONS: Findings did not clarify the role of intradiscal drainage when it was indicated in all cases of spondylodiscitis with fluid collection. Future studies with larger sample sizes of selected discitis cases are expected to demonstrate the superiority of intradiscal drainage.

Cost-effectiveness analysis of intradiscal condoliase injection vs. surgical or conservative treatment for lumbar disc herniation.

AIMS: This study aimed to analyze the cost-effectiveness of intradiscal condoliase injection compared to surgical or conservative treatment for patients with lumbar disc herniation (LDH) who are refractory to conservative treatment. METHODS: We performed the following cost-effectiveness analyses: (I) condoliase followed by open surgery (for non-responders to condoliase) vs. open surgery from the beginning, (II) condoliase followed by endoscopic surgery (for non-responders to condoliase) vs. endoscopic surgery from the beginning, and (III) condoliase + conservative treatment vs. conservative treatment. In the first two comparisons with surgical treatments, we assumed that utilities were equal in both groups and estimated the tangible (treatment, adverse events, postoperative follow-up) and intangible (mental and physical burden, and productivity loss) costs based on the existing literature, the medical expense scoring table, and online questionnaire. In the last comparison without surgical treatment, we estimated the incremental cost-effectiveness. RESULTS: The average cost per patient of condoliase followed by open surgery (for non-responders to condoliase) was 701,643 yen, with a reduction of 663,369 in comparison to that of open surgery from the beginning (1,365,012 yen). The average cost per patient of condoliase followed by endoscopic surgery (for non-responders to condoliase) was 643,909 yen, with a reduction of 514,909 in comparison to that of endoscopic surgery from the beginning (1,158,817 yen). ICER was 1.58 million yen/QALY (ΔQALY = 0.119, 95% confidence interval: 0.059-0.180; Δcost = 188,809 yen at 2 years post-treatment). CONCLUSIONS: Condoliase as a first line treatment option ahead of surgical treatment for LDH is superior, from a cost perspective, to surgical treatment from the beginning. Condoliase is also a cost-effective alternative to non-surgery conservative treatment.

Effect of intradiscal local anesthetic injection on intraoperative pain during percutaneous transforaminal endoscopic discectomy: A retrospective study.

OBJECTIVE: Patients undergoing percutaneous transforaminal endoscopic discectomy (PTED) often complain of unbearable intraoperative pain. This study is to observe clinical effectiveness and safety of intradiscal local anesthetic injection for intraoperative pain relief. METHODS: Total 268 patients who underwent PTED were analyzed. Patients were divided into intradiscal saline injection group (group C) and intradiscal local anesthetic injection group (group L). Intradiscal mixture was consisted of saline or local anesthetic + methylene blue, the amount of injected mixture was 3 mL. Demographic data, visual analog scale (VAS) and Quebec Back Pain Disability Scale (QBPDS) scores, mean arterial pressure (MAP) and heart rate (HR), total dosage of fentanyl, satisfaction rate of anesthesia and complications were collected at different timepoints. RESULTS: Compared with group C (3.94 ± 0.57), there was a significant reduction of VAS in group L (2.83 ± 0.28) during fibrous annular operation phase (T2). Group L had a lower total dosage of fentanyl (71 [63, 78] µg) and a higher anesthesia satisfaction rate (95.3%) than group C (82 [70, 132] µg and 73.6%, respectively) (P < 0.001). MAP and HR were lower in group L than in group C at T2 (P < 0.001). Baseline characteristics and QBPDS scores showed no meaningful intergroup differences. Four cases of complications were reported in this study. CONCLUSION: Intradiscal local anesthetic injection significantly alleviated intraoperative back pain and increased the satisfaction rate of anesthesia, without severe complications, indicating that this technique is a feasible method for intraoperative back pain relief for patients undergoing PTED.