Discogel Certificates/Scientific Articles
Bacteriostatic and Bactericidal Effects of DISCOGEL®
Samira Shirzadfar, Armin Khavandegar, Nooshin Taherzadeh Ghahfarokhi, Soheila Hosseinzadeh, Majid Zohrabi, Mahnaz Jamee1, Kiana Zohrabi and Somayeh Yaslianifard
Abstract and figures
Intradiscal DISCOGEL® injection is an accepted interventional method for the treatment of intervertebral disc herniation. This injectable implant, also known as Radiopaque Gelified Ethanol (RGE), consists of jellified ethanol in combination with a radiopaque agent, tungsten, and has various mechanisms of action. Studies have reported Discogel to be the most effective and safest therapeutic method with long-term benefits, a success rate of 91.4%, and a risk of complications of less than 0.5%. In this study, we investigated the antibacterial effects of Discogel against seven common bacterial strains involved in post-intervention and post-surgical infections, namely P. aeruginosa, S. aureus, E. faecalis, S. pyogenes, C. acnes, A. baumannii, and K. aerogenes. In-vitro experiments and statistical analysis revealed that different concentrations of DISCOGEL® have significant activity against all tested bacterial strains. No significant relationship between the Gram classification of bacteria and the antibacterial effects of DISCOGEL® was observed. this injectable implant is responsible for these additional benefits.
https://www.researchgate.net/publication/351328006_Bacteriostatic_and_Bactericidal_Effects_of_DISCOGELR
Effect of DiscoGel treatment of the intervertebral disc at MRI
K. Latka, K. Kozlowska, M. Waligora, W. Kolodziej, D. Latka
Aim:
To determine the impact of ethanol gel chemonucleolysis (EGCh) on the radiological picture of the treated intervertebral disc, the relationship between the initial radiological status and the clinical status of the patient after EGCh treatment, and the optimal radiographic criteria for qualifying a patient for EGCh treatment.
Materials And Methods:
The study involved a group of 45 patients (25 men and 20 women) aged 23 to 68 years (46 ± 11) who underwent an EGCh procedure after qualification, radiography, and clinical questionnaire evaluation.
Results:
The results showed a decrease in the size of the protrusion and GI zone in the treated intervertebral disc. The presence of a high-intensity zone (HIZ) on baseline magnetic resonance imaging was found to be a good predictor of the timing and outcome of treatment, and an increase in disc height was observed in adjacent segments.
Conclusion:
These findings suggest that EGCh is a promising treatment for spine diseases, and the HIZ on baseline magnetic resonance imaging can be used as a qualification criterion for this procedure.
https://pubmed.ncbi.nlm.nih.gov/37633745/
Clinical Radiology ( IF 2.6 ) Pub Date: 2023-08-15, DOI:10.1016/j.crad.2023.07.023
Radiopaque Gelified Ethanol Application in Lumbar Intervertebral Soft Disc Herniations: Croatian Multicentric Study
Karlo Houra, MD, PhD, Darko Perovic, MD, PhD, Ivan Rados, MD, PhD, Drazen Kvesic, MD
Abstract
Objective:
Minimally invasive percutaneous spinal procedures are popular in trying to reduce spinal pain. This paper aims to evaluate the safety of intervertebral disc chemonucleolysis and to report the effectiveness of a percutaneous, minimally invasive treatment for contained herniated intervertebral discs in the lumbar spine using the recently marketed radiopaque gelified ethanol.
Methods:
Pain relief before and after the procedure was self-evaluated by each patient using a verbal numeric scale (VNS) ranging from 0 to 10. Patients were also scored prior to the procedure and after chemonucleolysis during several follow-up periods using the Roland-Morris low back pain and disability questionnaire (RMQ). Follow-up periods were defined as 0–6, 6–12, 12–18, 18–24, and 24–30 months. Clinically significant functional improvement (CSFI) was defined as a decrease of five or more points on the RMQ scale and a decrease of at least 50% in pain intensity using VNS.
Results:
Using the RMQ scale, CSFI was achieved in 20/29 patients in the first follow-up period, 20/27 patients in the second follow-up period, 9/12 patients in the third follow-up period, 8/9 patients in the fourth follow-up period, and 4/4 patients in the last follow-up period. Using the VNS rating, CSFI was accomplished in 19/29 patients in the first follow-up period, 19/27 patients in the second follow-up period, 9/12 patients in the third follow-up period, 8/9 patients in the fourth follow-up period, and 4/4 in the last follow-up period.
Conclusions:
Intradiscal application of gelified ethanol may be effective in pain reduction using the VNS and Roland-Morris low back pain and disability questionnaire. The treatment is safe and easy to handle.
https://academic.oup.com/painmedicine/article/19/8/1550/4571791
Comparison of the Efficacy Between Intradiscal Gelified Ethanol (Discogel) Injection and Intradiscal Combination of Pulsed Radiofrequency and Gelified Ethanol (Discogel) Injection for Chronic Discogenic Low Back Pain Treatment. A Randomized Double-Blind Clinical Study
Dimitrios Papadopoulos, Chrysanthi Batistaki, Georgia Kostopanagiotou
Abstract:
Objective The aim of the present study was to compare two new techniques, intradiscal gelified ethanol injection (Discogel) and the combination of intradiscal pulsed radiofrequency and gelified ethanol injection (PRF+Discogel), regarding their efficacy in discogenic low back pain treatment. Design Randomized, double-blind, clinical study. Methods The final sample was randomized into group A (N = 18, D) and group B (N = 18, PRF+D). During the procedure, four patients from group B were excluded from the study. Groups A and B were assessed regarding the pain score (VAS 0–10), before the interventional procedures, and one, three, six, and 12 months after. The secondary objectives of the study were to compare the two groups regarding the results of the Roland Morris Disability Questionnaire, Lanss score, and quality of life score (EQ-5D). Results There was no significant evidence for an overall difference in pain score between the two groups (analysis of variance, F = 3.24, df = 1, P = 0.084), except for the sixth and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). Group B appeared to be more effective, with a statistically significant difference, compared with group A regarding the secondary objectives of the study. Conclusions After rigorous and comprehensive assessment by an independent observer, both Discogel alone and Discogel in combination with pulsed radiofrequency produced tangible improvements in pain, function, quality of life, and consumption of analgesics, which were sustained at 12 months.
https://scite.ai/reports/comparison-of-the-efficacy-between-KEE8kGJ
Efficacy and durability of radiopaque gelified ethanol in management of herniated discs
Dimitrij Kuhelj, Anita Dobrovolec, Igor Jozef Kocijancic1
Background:
Percutaneous image-guided intradiscal injection of gelified ethanol was introduced to treat herniated disc disease lately. The aim of the study was to assess clinical efficacy and durability over a 36 months’ period.
Patients and methods:
Eighty-three patients (47 males, 36 females, mean age 48.9 years (18–79 years) were treat-ed between May 2014 and December 2015 for 16 cervical and 67 lumbar chronical contained disc herniations. For pain assessment evaluation, the visual analog scale (VAS) was used. Physical activity, the use of analgesics, patients’ satisfaction with the treatment results and patient’s willingness to repeat the treatment were also evaluated.
Results:
Fifty-nine patients responded to questionnaire. 89.8% had significant reduction in VAS after 1 month (p <0.001); 76.9% of patients with cervical symptoms and 93.5% of patients with lumbar symptoms. In cervical group it remained stable, while in lumbar group VAS decreased even more during 36 months (p = 0.012). Single patient had spinal surgery. Moderate and severe physical disability prior to treatment (96.6%) was reduced to less than 30% after12 months. The majority of active patients returned to their regular job (71.1%); 78% needed less analgesics. Only 5.1%patients were not satisfied with the treatment and 10.2% would not repeat the treatment if needed.
Conclusions:
Percutaneous image-guided intradiscal injection of gelified ethanol is safe, effective and durable therapy for chronic contained cervical and lumbar herniations. Due to minimal invasiveness and long-lasting benefits, this kind of treatment should be proposed to designated group of patients as first-line therapy.
https://sciendo.com/article/10.2478/raon-2019-0026
Effects on pain of percutaneous treatment of cervical disc herniations using DiscoGel: A retrospective analysis
Roberto Fiori, Marco Forcina, Carlo Di Donna, Luigi Spiritigliozzi, Armando Ugo Cavallo, and Roberto Floris
Abstract
Background and purpose:
Cervical discogenic pain originates from degenerated intervertebral discs and is a common condition in the middle-aged population. Cervical discs may herniate and give compressions to cervical nerves, with pain and functional limitation of the arms. DiscoGel is a device that can be useful in the treatment of cervical disc herniation, with very short operating time and low radiation dose.
Material and methods:
Between March 2018 and April 2019 we performed this procedure on 38 patients with non-fissurated cervical herniation using 0.3–0.4 mL of DiscoGel injected under fluoroscopic guidance. The most common discs affected were C5–C6, C6–C7 and C4–C5. Outcomes were evaluated with Visual Analogue Scale (VAS) and Neuropathic Pain Symptom Inventory (NPSI) scores at 3, 6 and 12 months follow-up. A magnetic resonance imaging (MRI) scan of the cervical spine was performed 3 months after the procedure.
Results:
Postoperative examinations showed: VAS 2.15 ± 1.34 and NPSI 2.29 ± 0.71.
Postoperative MRI performed 3 months after the procedure showed a good improvement of cervical disc herniation or bulging or protrusion. The mean dose area product (DAP) was 2803 mGy/cm2 with a mean fluoroscopy time of 4 minutes 22 seconds.
Conclusion:
DiscoGel is a suitable approach for non-fissurated cervical disc herniations, especially in patients that are not suitable for open surgery, with excellent postoperative results, fast recovery, and a low radiation dose.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447813/
Efficacy of DiscoGel in Treatment of Degenerative Disc Disease: A Prospective 1-Year Observation of 67 Patients
Abstract
Patients with degenerative disc disease may suffer from chronic lumbar discogenic (DP) or radicular leg (RLP) pain. Minimally invasive DiscoGel therapy involves the percutaneous injection of an ethanol gel into the degenerated disk’s nucleus pulposus. This paper compares the 1-year outcome of such treatment in DP and RLP patients. We operated on 67 patients (49 men and 18 women) aged 20–68 years (mean age 46 ± 11 years) with DP (n = 45) and RLP (n = 22), of at least 6–8 weeks duration, with no adverse effects. We evaluated the treatment outcome with Core Outcome Measures Index (COMI) and Visual Analog Scale (VAS). A year after the ethanol gel injection, in the DP cohort, COMI and VAS dropped by 66% (6.40 vs. 2.20) and 53% (6.33 vs. 2.97), respectively. For the RLP patients, the corresponding values dropped 48% (7.05 vs. 3.68) and 54% (6.77 vs. 3.13). There were no differences between the cohorts in COMI and VAS at the follow-up end. Six months into the study, 74% of DP and 81% of RLP patients did not use any analgesics. Ethanol gel therapy can be effective for many patients. Moreover, its potential failure does not exclude surgical treatment options.
https://www.mdpi.com/2076-3425/11/11/1434
Cervical Discogenic Pain Treatment with Percutaneous Jellified Ethanol: Preliminary Experience
Haytham Eloqayli
Abstract
Background. Percutaneous DiscoGel® (Gelscom SAS, France), introduced in 2007 as a promising new minimal invasive technique, showed efficacy and safety in lumbar spine surgery, with limited use and scientific reports with regard to the cervical spine. Since the first publication of its use on the cervical spine (2010), less than 100 cases have been published. We introduce an initial experience with this relatively new procedure. We hypothesized that percutaneous DiscoGel® is a safe and effective option for chronic neck pain of cervical discogenic origin. Method. This was a clinical study on 10 patients with chronic discogenic pain operated on for 18 cervical discs with percutaneous DiscoGel®. Inclusion criteria were patients with chronic axial or referred neck pain with MRI showing a cervical disc that is consistent with patient symptoms and failed conservative treatment. Exclusion criteria were clinical myelopathy, motor deficit, severe stenosis or reduced disc height by more than 50%, or previous cervical spine surgery. Results. A total of 10 cases consisting of 6 females and 4 males underwent treatment with percutaneous DiscoGel® for 18 cervical discs. C5/C6 was the most affected level. The mean preoperative VAS score was 8; the postoperative VAS scores at 6 weeks and 3 months were 2.2 and 2.9, respectively. There were no postoperative complications or neurological deficits. Conclusion. The present study has the limitation of the small number of cases; however, with the limited number of studies and less than 100 published cases in the literature, this initial work shows that cervical percutaneous DiscoGel® is an effective minimally invasive bridging option between conservative and open surgical treatment for cervical discogenic pain, with a high success rate. The differentiation of pain types (nociceptive, referred, radicular, and trapezius myalgia) that can coexist is crucial for procedure selection and improving treatment outcomes.
https://www.hindawi.com/journals/bmri/2019/2193436/
Long-term Clinical Effects of Disco Gel for Cervical Disc Herniation
Andrzej Jaremko
Background:
Radiopaque gelified ethanol (RGE; DiscoGel®, Gelscom SAS, France) is used as a chemonucleolysis substance in treating intradiscal herniation, showing good results without complications. It has also been used in cervical disc herniations (CDHs), demonstrating the potential efficacy of this substance. Objective: The aim of the study is to investigate the long-term effectiveness and safety of DiscoGel ® in patients with CDH and chronic neck pain. Study Design: This is a cross-sectional, single-center study.
https://www.academia.edu/41675954/Long_term_Clinical_Effects_of_Disco_Gel_for_Cervical_Disc_Herniation20200119_23543_tiqw5c
Efficacy of an ethyl alcohol gel in symptomatic disc herniation
Stefano Marcia, Matteo Bellini, Joshua A. Hirsch, Ronil V. Chandra, Emanuele Piras,Mariangela Marras, Anna Maria Sanna, Luca Saba
Back pain (BP) is one of the most common disorders worldwide with a significant impact on public health. It is estimated that about 80% of adults in the Western world will suffer from BP at some point in their lives. One of the most frequent causes of BP is disc herniation (DH), which triggers pain pathways via mechanical compression together with immunologic and inflammatory changes.
Purpose:
To evaluate the clinical outcome of DiscoGel chemonucleolysis for symptomatic disc herniation in patients who fail conservative treatment.
Material and methods:
Consecutive patients with symptomatic disc herniation confirmed on MRI who failed conservative management for at least 6 months were included. Visual analogue scale (VAS), Oswestry Disability Index (ODI) scores, and analgesic use were recorded at baseline, and 12 months after treatment. Multi detector CT (MDCT) was performed at baseline, and 12 months after treatment to assess for DiscoGel extravasation and alteration in treated disc volume. In a unique long-term subgroup analysis of 31 patients, telephonic follow-up was performed utilizing VAS and ODI parameters 7years after the procedure.
Results:
A total of 87 disc herniations were treated in 71 patients; the majority (54%) were treated at L4/5 and L5/S1. VAS score of 8 before treatment was reduced to 3 at 12 months after treatment (p=0.0001); ODI score of 51 before treatment was reduced to 15 at 12 months after treatment (p=0.0001). Analgesic use of 70.4% was reduced to 29.6% after treatment. There were no symptomatic procedural complications; MDCT revealed 1 asymptomatic peri-neural DiscoGel extravasation. In the 31 subjects that underwent telephonic follow-up the VAS and ODI parameters maintained their values without statistically significant differences when compared with the 12-month follow-up.
https://www.academia.edu/88442981/Efficacy_of_an_ethyl_alcohol_gel_in_symptomatic_disc_herniation
Effects on pain of percutaneous treatment of cervical disc herniations using DiscoGel: A retrospective analysis
Roberto Fiori, Marco Forcina, […], and Roberto Floris
Abstract
Background and purpose
Cervical discogenic pain originates from degenerated intervertebral discs and is a common condition in the middle-aged population. Cervical discs may herniate and give compressions to cervical nerves, with pain and functional limitation of the arms. DiscoGel is a device that can be useful in the treatment of cervical disc herniation, with a very short operating time and low radiation dose.
Material and methods
Between March 2018 and April 2019 we performed this procedure on 38 patients with non-fissurated cervical herniation using 0.3–0.4 mL of DiscoGel injected under fluoroscopic guidance. The most common discs affected were C5–C6, C6–C7 and C4–C5. Outcomes were evaluated with Visual Analogue Scale (VAS) and Neuropathic Pain Symptom Inventory (NPSI) scores at 3, 6 and 12 months follow-up. A magnetic resonance imaging (MRI) scan of the cervical spine was performed 3 months after the procedure.
Results
Postoperative examinations showed: VAS 2.15 ± 1.34 and NPSI 2.29 ± 0.71.
Postoperative MRI performed 3 months after the procedure showed a good improvement of cervical disc herniation or bulging or protrusion. The mean dose area product (DAP) was 2803 mGy/cm2 with a mean fluoroscopy time of 4 minutes 22 seconds.
Conclusion
DiscoGel is a suitable approach for non-fissurated cervical disc herniations, especially in patients that are not suitable for open surgery, with excellent postoperative results, fast recovery, and a low radiation dose.
https://journals.sagepub.com/doi/abs/10.1177/19714009211000622
Clinical outcome and safety of percutaneous Radiopaque Gelified Ethanol injection in patients with persisting lumbar disc herniation
Stavros Charalambous1, Adam Hatzidakis1, Konstantinos Spanakis1, Andreas Yannopoulos2, Despo Ierodiakonou3, Apostolos Karantanas1
Purpose:
To investigate the efficacy and safety of radiopaque gelified ethanol (RGE) injection in patients with medium to large size intervertebral lumbar disc hernias including cases requiring alternative access routes. Material and Methods: Between December 2014 and June 2018, twenty-five patients (14 males, 11 females, median age 52 years (min 21-max 90 years)), were treated for equal number of intervertebral disc hernias by means of RGE injection under computed tomography (CT)-guidance. All patients were free from neurologic deficits and reported low back pain resistant to conservative treatment for at least six weeks. Pre- and post-treatment pain was evaluated using a visual analog scale (VAS) score and the VAS difference pre- and post- (6 months) treatment was tested with Wilcoxon matched-pair signed-rank test. Patients were then categorised into groups according to % change in VAS (poor 0%), good (1-99%), and excellent (100%) pain response). The association of results with quality of life (QoL) (high vs. low) was assessed using Fisher’s exact test.
Results:
At the end of the 6-month follow-up, pain was significantly improved (mean (SD) in VAS was dropped from 8.1 (1.26) to 3.1 (3.10); mean (95% CI) decrease 5.0 (3.6, 6.4) (p<0.001)). Pain response to treatment was excellent in 8 (32%) patients, good in 11 (44%) and poor in 6 (24%) and was significantly associated with the QoL (p<0.001). Conclusions: Percutaneous CT-guided intradiscal RGE injection is safe, easy to handle, and offers a good therapeutic outcome with better QoL.
https://www.academia.edu/99903136/Clinical_outcome_and_safety_of_percutaneous_Radiopaque_Gelified_Ethanol_injection_in_patients_with_persisting_lumbar_disc_herniation
Retrospective comparison of clinical effects of Discogel radiopaque gelified ethanol application in chronic pain related to cervical disc hernia
Serbülent Gökhan Beyaz, Ali Metin Ülgen and Mehmet Fatih Yüce
Introduction: Cervical disc hernia is a pathological condition that usually causes pain in the neck, shoulders, and arms (1), while radiculopathy and myelopathy caused by compression of the spinal cord are rare. In this study, we aimed to retrospectively investigate the clinical effects of Discogel® Radiopaque Gelified Ethanol application in patients with cervical disc hernia who had chronic pain and weakness in the neck, shoulders and arms. Material method: Between the years 2013 and 2014, 18 patients with chronic pain related to cervical disc hernia who were admitted to Sakarya University Education and Training Hospital were enrolled in the study. All intervention was performed with 22 Gauge spinal needle under fluoroscopy (Figure 1). Data of age, gender, visual analog scale (VAS) score before the procedure, VAS in the 1st and 3rd months after the procedure, Oswestry Disability Index (ODI) score, and scores of Neuropathic Pain Questionnaire (DN-4) were retrospectively analyzed. VAS and ODI scores obtained before the procedure and also in the 1st and 3rd months after the procedure were retrospectively evaluated and the SPSS IBM 20 program was used in statistical analysis. Adverse effects were recorded after the procedure. Results: The average age of the patients was 48.17 ± 10.23. In the comparison of preoperative, postoperative 1st, and 3rd months VAS values, the decrease in both postoperative values was accepted as significant (p<0.05). Although a decrease between 1st and 3rd month postoperative VAS values was detected, this was not statistically significant (p>0.05). In the comparison of postoperative 1st month, postoperative 3rd month, and preoperative ODI values, ODI scores were found to be improved (p<0.05). Similarly, change in DN-4 values was correlated with VAS and ODI scores (p<0.05). After the operation, 50% of the patients had sore throat, 44% had dysphagia, and 27% had neck stiffness and transient increase in pain. Conclusion: Cervical discogel application involves the injection of gelified ethanol (alcohol) (2) into the bulging part of the herniating intervertebral discoGel contains alcohol which does not go out of the disc and alcohol causes hernia to dry. In this way, it decreases the compression of the spinal cord and nerve roots. (2) We think that Discogel Radiopaque Gelified Ethanol application is a technique that decreases pain scores, the degree of neuropathic pain, and the functional status of patients who have the symptoms of chronic pain and weakness in the neck, shoulders, and arms.
https://www.omicsonline.org/2167-0846/2167-0846.S1.003-015.pdf
Overview on Percutaneous Therapies of Disc Diseases
Salvatore Masala, Fabio Salimei, Adriano Lacchè, Stefano Marcia, and Francesco Massari
Abstract
Low back pain is an extremely common pathology affecting a great share of the population, in particular, young adults. Many structures can be responsible for pain such as intervertebral discs, facet joints, nerve roots, and sacroiliac joints. This review paper focuses on disc pathology and the percutaneous procedures available to date for its treatment. For each option, we will assess the indications, technical aspects, advantages, and complications, as well as outcomes reported in the literature and new emerging trends in the field.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6722686/
DiscoGel® in patients with discal lumbosciatica. Retrospective results in 25 consecutive patients
A. Léglise a, J. Lombard b, A. Moufid a
Abstract
Introduction
Discogenic lumbosciatica is a common disorder in patients between 30 and 40 years old. Because of the frequency and socio-professional impact of this entity, it represents a real public health problem. DiscoGel® is a class III medical device used for nucleolysis to avoid discectomy. The goal of this study was to evaluate the effectiveness of this treatment in patients with discogenic lumbosciatica following unsuccessful conservative medical treatment.
Materials and methods
This is a retrospective, single-center study including 25 patients who were treated with DiscoGel® between 2010 and 2011 at Niort Hospital, France. The severity of lumbar and radicular pain was assessed by a verbal numeric scale (VNS) and patient satisfaction. Patients were classified as successes or failures.
Results
Treatment was found to reduce the severity of lumbar pain in 73% and of radicular pain in 80% of patients in the success group. Treatment was a failure in 64% of patients. A comparison of the two groups showed that a preoperative MODIC 2 MRI signal of the adjacent vertebral end plate was significantly associated with treatment failure (Chi2 = 8572, P < 0.01).
Discussion
The VNS for lumbar pain and radicular pain decreased in 42% and 50% of patients respectively after the use of DiscoGel®. In our series, DiscoGel® treatment was unsuccessful for discogenic lumbosciatica in 16 patients. These results do not support others in the literature. A lack of statistical power could partly explain these results. The most important result of this study is found in the subgroup analysis which suggests that indications for DiscoGel® treatment could be modified in the future in relation to preoperative imaging data.
https://www.sciencedirect.com/science/article/pii/S187705681500153X#:~:text=DiscoGel%C2%AE%20is%20a%20new,case%20of%20unsuccessful%20medical%20treatment.
Effectiveness of intradiscal injection of radiopaque gelified ethanol (DiscoGel®) versus percutaneous laser disc decompression in patients with chronic radicular low back pain
Masoud Hashemi, Payman Dadkhah, Mehrdad Taheri, Pegah Katibeh, and Saman Asadi
Abstract
Background
Low back pain secondary to discopathy is a common pain disorder. Multiple minimally invasive therapeutic modalities have been proposed; however, to date no study has compared percutaneous laser disc decompression (PLDD) with intradiscal injection of radiopaque gelified ethanol (DiscoGel®). We are introducing the first study on patient-reported outcomes of DiscoGel® vs. PLDD for radiculopathy.
Methods
Seventy-two patients were randomly selected from either a previous strategy of PLDD or DiscoGel®, which had been performed in our center during 2016–2017. Participants were asked about their numeric rating scale (NRS) scores, Oswestry disability index (ODI) scores, and progression to secondary treatment.
Results
The mean NRS scores in the total cohort before intervention was 8.0, and was reduced to 4.3 in the DiscoGel® group and 4.2 in the PLDD group after 12 months, which was statistically significant. The mean ODI score before intervention was 81.25% which was reduced to 41.14% in the DiscoGel® group and 52.86% in the PLDD group after 12 months, which was statistically significant. Between-group comparison of NRS scores after two follow-ups were not statistically different (P = 0.62) but the ODI score in DiscoGel® was statistically lower (P = 0.001). Six cases (16.67%) from each group reported undergoing surgery after the follow-up period which was not statistically different.
Conclusions
Both techniques were equivalent in pain reduction but DiscoGel® had a greater effect on decreasing disability after 12 months, although the rate of progression to secondary treatments and/or surgery was almost equal in the two groups.
Keywords:
Chronic Pain, Disability Evaluation, Discectomy, Intervertebral Disc, Low Back Pain, Pain Management, Radiculopathy, Visual Analog Scale
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6944373/#:~:text=Since%202014%2C%20many%20other%20investigations,12%2C13%2C28%5D.
Treatment of chronic low back pain – new approaches on the horizon
Knezevic NN , Mandalia S, Raasch J , Knezevic I, Candido KD
Abstract:
Back pain is the second leading cause of disability among American adults and is currently treated either with conservative therapy or interventional pain procedures. However, the question that remains is whether we, as physicians, have adequate therapeutic options to offer to the patients who suffer from chronic low back pain but fail both conservative therapy and interventional pain procedures before they consider surgical options such as discectomy, disc arthroplasty, or spinal fusion. The purpose of this article is to review the potential novel therapies that are on the horizon for the treatment of chronic low back pain. We discuss medications that are currently in use through different phases of clinical trials (I–III) for the treatment of low back pain. In this review, we discuss revisiting the concept of chemonucleolysis using chymopapain, as the first drug in an intradiscal injection to reduce herniated disc size, and newer intradiscal therapies, including collagenase, chondroitinase, matrix metalloproteinases, and ethanol gel. We also review an intravenous glial cell-derived neurotrophic growth factor called artemin, which may repair sensory nerves compressed by herniated discs. Another new drug in development for low back pain without radiculopathy is a subcutaneous monoclonal antibody acting as a nerve growth factor called tanezumab. Finally, we discuss how platelet-rich plasma and stem cells are being studied for the treatment of low back pain. We believe that with these new therapeutic options, we can bridge the current gap between conservative/interventional procedures and surgeries in patients with chronic back pain.
Keywords:
chronic low back pain, clinical trials, chemonucleolysis, tanezumab, artemin, PRP, stem cells, new therapy
https://www.dovepress.com/treatment-of-chronic-low-back-pain-new-approaches-on-the-horizon-peer-reviewed-fulltext-article-JPR
Intradiscal and Intramuscular Injection of Discogel(R) -- Radiopaque Gelified Ethanol: Pathological Evaluation
Gianluigi Guarnieri
Abstract and Figures
This study assessed the impact and modification of intradiscal, intraforaminal, epidural and intramuscular swine injection of a new material, Discogel(®)- radiopaque gelified ethanol- recently introduced for the mini-invasive treatment of herniated disc. Discogel(®) is a sterile viscous solution containing ethyl alcohol, cellulose derivative product, added to a radio-opaque element, tungsten. The pig was sedated and under fluoroscopy guidance a needle was positioned within disc L1-L2 followed by intradiscal, intraforaminal, epidural and intramuscular injection of 1 ml of Discogel. As disc control level L4-L5 was considered where nothing was injected. The pig was sacrifed 48 h after injection of discogel and the spine from D10 to S1 was removed and fixed in 10% buffered formalin. The anatomical specimens were cut with an electric saw and analyzed by routine technique then stained with formalin. The specimens containing bone material were treated by DEKAL solution. The specimens were stained with hematoxylin-eosin method and then analyzed by histochemical (Masson -Van Gieson PAS and trichromic stains ) and immunochemical methods. Morphostructural examination disclosed a granular material coloured black by hematoxylin-eosin method (tungsten) in paravertebral tissue both in the muscular and connective tissue. Some inflammatory elements like lymphomonocyte cells and venous stasis were found. No alteration was found where discogel was injected, and the nucleus pulposus, disc, chondromixoid and root ganglium were normal. After intradiscal, intraforaminal, epidural and intramuscular injection of Discogel(®) no morpho-structural changes in nuclear tissue and annulus were found. Further studies on pigs with immunohistochemical analysis after treatment will confirm the morphological alterations induced by discogel and its action.
https://www.researchgate.net/publication/258034288_Intradiscal_and_Intramuscular_Injection_of_DiscogelR_--_Radiopaque_Gelified_Ethanol_Pathological_Evaluation
Percutaneous Injection of Radiopaque Gelified Ethanol for the Treatment of Lumbar and Cervical Intervertebral Disk Herniations: Experience and Clinical Outcome in 80 Patients
M. Bellini, D.G. Romano, S. Leonini, I. Grazzini, C. Tabano, M. Ferrara, P. Piu, L. Monti and A. Cerase
Abstract
BACKGROUND AND PURPOSE:
Chemonucleolysis represents a minimally invasive percutaneous technique characterized by an intradiskal injection of materials under fluoroscopic or CT guidance. Recently, a substance based on radiopaque gelified ethanol has been introduced. The purpose of this study was to describe the indications, procedure, safety, and efficacy of radiopaque gelified ethanol in the percutaneous treatment of cervical and lumbar disk herniations.
MATERIALS AND METHODS:
Between September 2010 and August 2013, 80 patients (32 women and 48 men; age range, 18–75 years) were treated for 107 lumbar disk herniations (L2–L3, n = 1; L3–L4, n = 15; L4–L5, n = 53; and L5–S1, n = 38) and 9 cervical disk herniations (C4–C5, n = 2; C5–C6, n = 2; C6–C7, n = 3; and C7–D1, n = 2) by percutaneous intradiskal injection of radiopaque gelified ethanol under fluoroscopic guidance. Thirty-six patients underwent a simultaneous treatment of 2 disk herniations. Patient symptoms were resistant to conservative therapy, with little or no pain relief after 4–6 weeks of physical therapy and drugs. All patients were evaluated by the Visual Analog Scale and the Oswestry Disability Index.
RESULTS:
Sixty-two of 73 (85%) patients with lumbar disk herniations and 6/7 (83%) patients with cervical disk herniations obtained significant symptom improvement, with a Visual Analog Scale reduction of at least 4 points and an Oswestry Disability Index reduction of at least 40%. Leakage of radiopaque gelified ethanol in the surrounding tissues occurred in 19 patients, however without any clinical side effects.
CONCLUSIONS:
In our experience, percutaneous intradiskal injection of radiopaque gelified ethanol is safe and effective in reducing the period of recovery from disabling symptoms.
https://www.ajnr.org/content/36/3/600
Lumbar Percutaneous Intradiscal Injection of Radiopaque Gelified Ethanol (Discogel) in Patients with Low Back and Radicular Pain
Volpentesta, De Rose, Bosco, Stroscio, Guzzi, Bombardieri, Chirchiglia, Plastino, Romano, Cristofalo, Pardatscher and Lavano
Abstract
Partial removal of nucleus pulposus with consequent reduction of intradiscal pressure may be obtained with percutaneous intradiscal administration of chemical substances in the intervertebral disc. We used percutaneous intradiscal injection of radiopaque gelified ethanol (“Discogel”) in 72 patients (group 1) with conservative treatment-resistant lumbar and radicular pain due to small and medium-size hernias of intervertebral disc to demonstrate its efficacy and safety vs. 72 subjects treated with intra-foraminal and intradiscal injections of a steroid and anesthetic (group 2 or control group). “Discogel” injection was performed with biplane fluoroscopy assistance and under local anesthesia with patient in lateral position on symptomatic side. Amount of “Discogel” injected ranged from 0.8 ml to 1.6 ml. We treated a total of 83 discs. We performed the procedure on one disc in 62 patients; in 9 patients two discs were treated in the same session and in 1 patient three levels were treated in two separate sessions. In group 1 patient “responders” were 65 (90.3%). Excellent and good results were obtained in 58 patients (80.4%), satisfactory results in 7 patients (9.8%) and poor results in 7 patients (9.8%); among “responders” pain control was quite immediate in 58 patients (89.3%) while in 7 patients (10.7%) there was a delay of 7-10 days. These values were significantly higher than in control group. Also the quality of life was significantly more sustained vs. control group, and this benefit was maintained over time. Concerning complications, in 3 cases (4.15%) we had transitory radicular irritation with neuropathic pain appearance immediately after the procedure and in 1 case (1.30%) transitory sensory-motor deficit due to diffusion of local anesthetic along the introducer needle. In conclusion intradiscal radiopaque gelified ethanol injection is minimally invasive, low cost, safe and effective procedure that may be considered in proper selected patients before recourse to surgery.
https://www.omicsonline.org/open-access/lumbar-percutaneous-intradiscal-injection-of-radiopaque-gelified-ethanol-discogel-in-patients-with-low-back-and-radicular-pain-2167-0846.1000145.php?aid=26628#:~:text=Complications%20described%20for%20the%20use,3%20appearance%20of%20neuropathic%20pain.
Chemonucleolysis of lumbar disc herniation with ethanol
C Riquelme , M Musacchio, F Mont'Alverne, A Tournade
Abstract
Purpose:
To demonstrate the efficiency of the treatment of the lumbar disk herniation (LDH) with absolute alcohol.Materials/methods: From June 1997 to September 2000, 118 patients with 126 LDH, 69 males and 49 females, aged 19 to 77 (mean age: 51.1 years) were treated with absolute alcohol nucleolysis. In 75 cases, the LDH were parasagittal, in 30 foraminal, in 17 medial and in 4 extraforaminal. In most cases, the sensitive symptoms and motor or reflex abnormalities correspond to the lumbar disc herniation level. Nucleolysis was made in ambulatory condition and each patient underwent general anesthesia. All procedures were performed in surgical conditions and controlled under digital fluoroscopy. The disc puncture was laterally made at the junction of the middle and posterior thirds of the disc, under strict lateral fluoroscopic control. A discogram was obtained before ethanol injection. The injection dose of absolute alcohol was 0.4 ml. The realization time was about 15 minutes.
Result:
Total improvement of symptoms was obtained in 97.55% of cases. Two patients remained with low-back pain and the failure treatment rate was 0.84% (1 case).
Conclusion:
Nucleolysis with ethanol is a very effective, safe and low-cost treatment for any kind of LDH, It allows to treat several levels during the same procedure, and can be repeated several times. Nucleolysis with ethanol can be made in ambulatory conditions and be proposed to patients who refuse surgical treatment and have allergic backgrounds.
https://pubmed.ncbi.nlm.nih.gov/11924136/
Cohort study of lumbar percutaneous chemonucleolysis using ethanol gel in sciatica refractory to conservative treatment
Sébastien Touraine, Joël Damiano, Olivia Tran, Jean-Denis Laredo
Abstract
Purpose:
To investigate the efficacy of percutaneous chemonucleolysis using ethanol gel (PCEG) in alleviating radicular pain due to disc herniation after failure of conservative treatment.
Materials and methods:
After failure of conservative treatment, PCEG was performed under fluoroscopic guidance in 42 patients with sciatica >4/10 on a Visual Analog Scale (VAS) for at least 6 weeks and consistent disc herniation on MRI or CT <3 months. The VAS pain score was determined at baseline, then after 1 and 3 months. We assessed the influence of patient-related factors (age, gender, pain duration) and disc herniation-related factors (level, migration pattern, disc herniation-related spinal stenosis) on outcome of PCEG.
Results:
Mean pain duration was 6.7 months. Pain intensity decreased by 44% and 62.6% after 1 and 3 months, respectively, versus baseline (P = 0.007). A mild improvement was noted by the rheumatologist in 30/42 (71.4%) and 36/42 (85.7%) patients after 1 and 3 months, respectively, and in 31/42 (73.8%) and 33/42 (78.6%) patients by self-evaluation. Patients who failed PCEG were significantly older (49.8 vs. 37.3 years, P = 0.03). None of the other variables studied were significantly associated with pain relief.
Conclusion:
PCEG may significantly improve disc-related radicular pain refractory to conservative treatment.
Key points:
Percutaneous chemonucleolysis using ethanol gel (PCEG) is feasible on an outpatient basis. • PCEG improves disc-related radicular pain refractory to conservative treatment. • PCEG is feasible on an outpatient basis. • Failure of PCEG does not interfere with subsequent spinal surgery.
https://pubmed.ncbi.nlm.nih.gov/25903710/
Percutaneous injection of radiopaque gelified ethanol for the treatment of lumbar and cervical intervertebral disk herniations: experience and clinical outcome in 80 patients
M Bellini, D G Romano, S Leonini, I Grazzini, C Tabano, M Ferrara, P Piu, L Monti, A Cerase
Abstract
Background and purpose: Chemonucleolysis represents a minimally invasive percutaneous technique characterized by an intradiskal injection of materials under fluoroscopic or CT guidance. Recently, a substance based on radiopaque gelified ethanol has been introduced. The purpose of this study was to describe the indications, procedure, safety, and efficacy of radiopaque gelified ethanol in the percutaneous treatment of cervical and lumbar disk herniations.
Materials and methods:
Between September 2010 and August 2013, 80 patients (32 women and 48 men; age range, 18-75 years) were treated for 107 lumbar disk herniations (L2-L3, n = 1; L3-L4, n = 15; L4-L5, n = 53; and L5-S1, n = 38) and 9 cervical disk herniations (C4-C5, n = 2; C5-C6, n = 2; C6-C7, n = 3; and C7-D1, n = 2) by percutaneous intradiscal injection of radiopaque gelified ethanol under fluoroscopic guidance. Thirty-six patients underwent a simultaneous treatment of 2 disk herniations. Patient symptoms were resistant to conservative therapy, with little or no pain relief after 4-6 weeks of physical therapy and drugs. All patients were evaluated by the Visual Analog Scale and the Oswestry Disability Index.
Results:
Sixty-two of 73 (85%) patients with lumbar disk herniations and 6/7 (83%) patients with cervical disk herniations obtained significant symptom improvement, with a Visual Analog Scale reduction of at least 4 points and an Oswestry Disability Index reduction of at least 40%. Leakage of radiopaque gelified ethanol in the surrounding tissues occurred in 19 patients, however without any clinical side effects.
Conclusions:
In our experience, percutaneous intradiskal injection of radiopaque gelified ethanol is safe and effective in reducing the period of recovery from disabling symptoms.
https://pubmed.ncbi.nlm.nih.gov/25395657/
The Effects of Alcohol Celiac Plexus Block, Pain, and Mood on Longevity in Patients With Unresectable Pancreatic Cancer: A Double-blind, Randomized, Placebo-controlled Study
Peter S. Staats MD, Hamid Hekmat PhD, Patricia Sauter RN, Keith Lillemoe MDAbstract
Objective
This additional analysis of data from a previously reported prospective trial comparing the effect of intraoperative alcohol or saline placebo neurolytic block in patients with pancreatic cancer was conducted in response to the development of a new theory, which explores the relationship of negative mood states to pain, pain-related behavior, and ultimately, longevity.
Methods
The original study used a double-blind procedure to randomly assign 139 patients with histologically proven, unresectable pancreatic cancer to receive either an alcohol or a saline block. Data on visual analog pain, mood, and interference with activity were collected preoperatively and every 2 months postoperatively until death. The current analysis was conducted on the complete data sets received from 130 patients. Demographic data were submitted to chi-square analysis and to univariate and multivariate analysis of variance. Univariate and multivariate analyses of variance also compared 1) the effect of alcohol versus saline on pain, mood, interference of pain with activities, and longevity and 2) the impact of mood on pain with longevity as the dependent variable. Correlation and regression analyses examined the impact of mood on life expectancy.
Results
The alcohol intervention had a significant positive effect on life duration and mood scores. High negative mood states correlated significantly with an increase in visual analog pain, the rating of pain intensity at its worst, and pain interference with patients' activities.
Conclusion
In these subjects, the neurolytic block, as compared with medical management alone, improved pain, elevated mood, reduced pain interference with activity and was associated with an increase in life expectancy.
https://onlinelibrary.wiley.com/doi/abs/10.1046/j.1526-4637.2001.002001028.x
Painful intervertebral disc degeneration and inflammation: from laboratory evidence to clinical interventions
Feng-Juan Lyu, Haowen Cui, Hehai Pan, Kenneth MC Cheung, Xu Cao, James C. Iatridis & Zhaomin Zheng
Abstract
Low back pain (LBP), as a leading cause of disability, is a common musculoskeletal disorder that results in major social and economic burdens. Recent research has identified inflammation and related signaling pathways as important factors in the onset and progression of disc degeneration, a significant contributor to LBP. Inflammatory mediators also play an indispensable role in discogenic LBP. The suppression of LBP is a primary goal of clinical practice but has not received enough attention in disc research studies. Here, an overview of the advances in inflammation-related pain in disc degeneration is provided, with a discussion on the role of inflammation in IVD degeneration and pain induction. Puncture models, mechanical models, and spontaneous models as the main animal models to study painful disc degeneration are discussed, and the underlying signaling pathways are summarized. Furthermore, potential drug candidates, either under laboratory investigation or undergoing clinical trials, to suppress discogenic LBP by eliminating inflammation are explored. We hope to attract more research interest to address inflammation and pain in IDD and contribute to promoting more translational research.
https://www.nature.com/articles/s41413-020-00125-x
Degenerate Human Nucleus Pulposus Cells Promote Neurite Outgrowth in Neural Cells
Stephen M. Richardson, Devina Purmessur, Pauline Baird, Ben Probyn, Anthony J. Freemont, Judith A. Hoyland
Abstract
Innervation of nociceptive nerve fibres into the normally aneural nucleus pulposus (NP) of the intervertebral disc (IVD) occurs during degeneration resulting in discogenic back pain. The neurotrophins nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF), which are associated with stimulation of axonal outgrowth and nociception by neuronal cells, are both expressed by NP cells, with BDNF levels increasing with disease severity. However the mechanism of interaction between human NP cells and neural cells has yet to be fully elucidated. Therefore the aim of this study was to determine whether non-degenerate or degenerate human NP cells inhibit or stimulate neural outgrowth and whether any outgrowth is mediated by NGF or BDNF. Human NP cells from non-degenerate and degenerate IVD were cultured in alginate beads then co-cultured for 48 hours with human SH-SY5Y neuroblastoma cells. Co-culture of non-degenerate NP cells with neural cells resulted in both an inhibition of neurite outgrowth and reduction in percentage of neurite expressing cells. Conversely co-culture with degenerate NP cells resulted in an increase in both neurite length and percentage of neurite expressing cells. Addition of anti-NGF to the co-culture with degenerate cells resulted in a decrease in percentage of neurite expressing cells, while addition of anti-BDNF resulted in a decrease in both neurite length and percentage of neurite expressing cells. Our findings show that while non-degenerate NP cells are capable of inhibiting neurite outgrowth from human neural cells, degenerate NP cells stimulate outgrowth. Neurotrophin blocking studies demonstrated that both NGF and BDNF, secreted by degenerate NP cells, may play a role in this stimulation with BDNF potentially playing the predominant role. These findings suggest that NP cells are capable of regulating nerve ingrowth and that neoinnervation occurring during IVD degeneration may be stimulated by the NP cells themselves.
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0047735
Annulus Fissures Are Mechanically and Chemically Conducive to the Ingrowth of Nerves and Blood Vessels
Stefanakis, Manos PT, PhD*; Al-Abbasi, Maan PhD*; Harding, Ian BMBCh, FRCS‡; Pollintine, Phillip PhD*; Dolan, Patricia PhD*; Tarlton, John PhD†; Adams, Michael A. PhD*
Study Design
Mechanical and biochemical analyses of cadaveric and surgically removed discs.
Objective.
To test the hypothesis that fissures in the annulus of degenerated human discs are mechanically and chemically conducive to the ingrowth of nerves and blood vessels.
Summary of Background Data
Discogenic back pain is closely associated with fissures in the annulus fibrosus, and with the ingrowth of nerves and blood vessels.
Methods
Three complementary studies were performed. First, 15 cadaveric discs that contained a major annulus fissure were subjected to 1 kN compression, while a miniature pressure transducer was pulled through the disc to obtain distributions of matrix compressive stress perpendicular to the fissure axis. Second, Safranin O staining was used to evaluate focal loss of proteoglycans from within annulus fissures in 25 surgically removed disc samples. Third, in 21 cadaveric discs, proteoglycans (sulfated glycosaminoglycans [sGAGs]) and water concentration were measured biochemically in disrupted regions of annulus containing 1 or more fissures, and in adjacent intact regions.
Results
Reductions in compressive stress within annulus fissures averaged 36% to 46% and could have been greater at the fissure axis. Stress reductions were greater in degenerated discs, and were inversely related to nucleus pressure (R2 = 47%; P = 0.005). Safranin O stain intensity indicated that proteoglycan concentration was typically reduced by 40% at a distance of 600 μm from the fissure axis, and the width of the proteoglycan-depleted zone increased with age (P < 0.006; R2 = 0.29) and with general proteoglycan loss (P < 0.001; R2 = 0.32). Disrupted regions of annulus contained 36% to 54% less proteoglycans than adjacent intact regions from the same discs, although water content was reduced only slightly.
Conclusion
Annulus fissures provide a low-pressure microenvironment that allows focal proteoglycan loss, leaving a matrix that is conducive to nerve and blood vessel ingrowth.
https://doi.org/10.1097%2FBRS.0b013e318263ba59
Intradiscal and Intramuscular Injection of Discogel® — Radiopaque Gelified Ethanol: Pathological Evaluation
G. Guarnieri gianluigiguarnieri@hotmail.it, G. De Dominicis, and M. MutoView all autho
Abstract
This study assessed the impact and modification of intradiscal, intraforaminal, epidural and intramuscular swine injection of a new material, Discogel(®)- radiopaque gelified ethanol- recently introduced for the mini-invasive treatment of herniated disc. Discogel(®) is a sterile viscous solution containing ethyl alcohol, cellulose derivative product, added to a radio-opaque element, tungsten. The pig was sedated and under fluoroscopy guidance a needle was positioned within disc L1-L2 followed by intradiscal, intraforaminal, epidural and intramuscular injection of 1 ml of Discogel. As disc control level L4-L5 was considered where nothing was injected. The pig was sacrifed 48 h after injection of discogel and the spine from D10 to S1 was removed and fixed in 10% buffered formalin. The anatomical specimens were cut with an electric saw and analyzed by routine technique then stained with formalin. The specimens containing bone material were treated by DEKAL solution. The specimens were stained with hematoxylin-eosin method and then analyzed by histochemical (Masson -Van Gieson PAS and trichromic stains ) and immunochemical methods. Morphostructural examination disclosed a granular material coloured black by hematoxylin-eosin method (tungsten) in paravertebral tissue both in the muscular and connective tissue. Some inflammatory elements like lymphomonocyte cells and venous stasis were found. No alteration was found where discogel was injected, and the nucleus pulposus, disc, chondromixoid and root ganglium were normal. After intradiscal, intraforaminal, epidural and intramuscular injection of Discogel(®) no morpho-structural changes in nuclear tissue and annulus were found. Further studies on pigs with immunohistochemical analysis after treatment will confirm the morphological alterations induced by discogel and its action.
https://pubmed.ncbi.nlm.nih.gov/24148546/