Discogel Frequently Asked Questions (Practitioners)

Interventional procedures or spinal surgery?

The North American Spine Society and other scientific authors (Kraemer et al., Legrand et al., Lorio et al.), agreed that conservative treatments, including medications and physical therapy, are considered the first-line strategy for herniated disc treatment;

The international society for the Advancement of Spine Surgery Policy 2019 and Wei Wang et al. suggested that a timeline between 4 to 10.5 months after onset should be follow-up before deciding to perform surgery, which presents the disadvantages to have higher costs and expose the patient to post-operative complications.

Minimally invasive treatments aiming to reduce intradiscal pressure of the herniated discs have been developed in the past two decades. Discogel® manufactured by GELSCOM is one of them. Through randomized prospective trials, minimally invasive treatments have been shown to be superior to conservative therapies and infiltrations with better and longer-lasting pain reduction and to have significant equivalent outcomes compared to open discectomy or micro-discectomy procedures. Percutaneous techniques, however, compared to open disc surgery, cause only minimal degeneration of the surrounding tissues, in particular, for muscles, which are a pivotal structure in the support of the degenerated intervertebral disc and are considerably more cost-effective (25–30%).

Taken together, this information allows stating that minimally invasive treatments can be considered for disc herniation treatment when conservative treatments, that are less expensive and considered as first-line strategy, failed, and before open discectomy or micro-discectomy procedures since these last techniques present equivalent outcomes but greater disadvantages in term of costs and complications.

Q: Is it necessary to inject a prophylactic antibiotic before Discogel injection?

A: This depends on the treating physician's discretion, but we administer prophylactic antibiotic injections, one dose before and one dose after Discogel injection, and we recommend this to you as well. Further antibiotic treatment at home will be determined based on the doctor's recommendation and hospital conditions.

Q: Can we use one Discogel vial for two different patients?

A: There's no issue if two patients are treated on the same day, as long as storage and sterility conditions are maintained.

However, keeping the leftover Discogel from one injection for later use or for other patients doesn't align with Discogel standards and isn't recommended.

Q: In which position is the Discogel injection performed for cervical and Lumbar disc herniation?

A: To perform a Discogel injection for the treatment of cervical disc herniation, the patient will typically lie down with their face upwards and extended. For injecting Discogel into the lumbar discs, two positions can be used: the right lateral decubitus position and the prone position.

Q: What is the best approach for entering the cervical disc for Discogel injection?

A: The safest and least risky place to insert the needle in the neck area is on the right side of the patient's neck.

Q: What is the best approach for entering the lumbar disc for Discogel injection?

A: The least risky place to insert the needle in the lower back area is on the left side of the patient's spinal column.

Q: Can we inject Discogel into the disc space from the left side?

A: Yes, but inserting the needle from the right side of the neck reduces the risk of the needle entering the Esophagus.

Q: Is Discogel injection effective for treating the recurrence of a disc after surgery on the same disc?

A: The effectiveness of Discogel injection for treating the recurrence of a disc after previous surgery is significantly reduced. However, it can be useful and effective for treating adjacent disc herniations near the surgical site.

Q: Can we inject DiscoGel with regular syringes?

A: According to Discogel standards, and to reduce the risk of a reaction between ethanol and the syringe walls, we are only allowed to use polycarbonate syringes for injecting this product.

Q: Do we need to perform a discography before or during Discogel therapy?

A: No, the tungsten present in Discogel allows damaged and ruptured areas to be fully visualized simultaneously with the injection of this substance (discography).

Q: How can reduce the risk of mistakenly injecting Discogel into surrounding tissues or the wrong places inside the disc?

A: The most important point to reduce the risk of mis-injection of Discogel into surrounding tissues and to increase precision in locating the nucleus pulposus is the use of fluoroscopy and C-arm guidance in both AP and Lat. views. Injection under CT scan guidance or the use of an O-Arm for precise needle placement can also be very helpful.

Q: What are the standard amounts of Discogel injected into the different discs?

A: The required amount of Discogel for different discs is determined based on the volume of each disc area. The standard amount of Discogel for different levels is as follows:

- Cervical: 0.2 ml

- Thoracic: 0.6 ml

- Lumbar: 0.8 ml

In our clinic, the amount of Discogel for each location may exceed the standard values mentioned.

Q: Is the needle entry point for Discogel injection determined based on the location of the damaged disc?

A: No, if Discogel is properly injected into the nucleus pulposus, it will naturally find its way toward the damaged disc areas. In the lumbar region, it's advisable to enter the needle from the left side of the spinal column to reduce the risk of injuring adjacent organs. Thoroughly mixing the tungsten sediment with the other substances in Discogel allows us to better track the path of Discogel movement inside the damaged disc (discography).

Q: Which one C-Arm view, is used for Discogel injection?

A: Performing periodic and repeated fluoroscopy in both anteroposterior and lateral views during Discogel injection is essential to reduce risk and enhance injection accuracy.

Q: What is the maximum injection rate of Discogel?

A: The maximum injection rate of Discogel is as follows:

Cervical: Less than 0.1 ml/min

Lumbar: Less than 0.2 ml/min

The time of injection to each disc: is at least 5 to 10 minutes. A low injection rate is more comfortable for the patient and will reduce the risk of extruded disc displacement.

Q: Is leakage of Discogel into the surrounding areas and epidural space dangerous?

A: Discogel leakage into the surrounding areas and epidural space is not typically dangerous, but it often indicates that a sufficient volume of this substance has been injected, and the injection can be concluded.

Q: Can we use Discogel simultaneously for treating multiple discs in one region or different regions?

A: Simultaneous injection of Discogel, with caution, at multiple levels is allowed. There is no prohibition against injecting it for both cervical and lumbar disc herniations in one session.

Q: How many lumbar discs can be treated at one time with Discogel injections?

A: In our clinic, the maximum number of lumbar discs for which Discogel can be performed is three. There is usually no restriction in terms of performing the injections, but it's important to note that if a patient has more than three lumbar discs involved, they may likely have spinal canal stenosis, and it's crucial to remember that Discogel is designed solely for injection into the intervertebral discs and cannot alleviate spinal canal stenosis.

Q: How many cervical discs can be treated at one time with Discogel injections?

A: In our clinic, we perform Discogel therapy for a maximum of four cervical discs. The information mentioned about lumbar disc herniations also holds true for cervical disc herniations.

Q: Why don't we use general anesthesia for Discogel injection?

A: In Discogel injection and other interventional disc herniation treatments, we avoid using general anesthesia for several reasons:

1. To reduce the risks associated with general anesthesia.

2. To allow us to monitor the patient's symptoms regularly throughout the treatment process.

Q: Why do we leave the needle in place for a few minutes after finishing the Discogel injection?

A: After completing the Discogel injection, leaving the needle in place for five to ten minutes is preferable to allow the Discogel to fully transform from a liquid state to a gel-like state. Then, we can cautiously remove it from the disc.

Q: Are we allowed to mix Discogel with other solutions?

A: No, we are not allowed to mix Discogel with any other substance. However, we can inject Gentamicin into the disc (to reduce the risk of infection) through the same Discogel needle.

Q: Does injecting Discogel increase the risk of infection inside the disc?

A: According to research conducted, the bacteriostatic and bactericidal effects of DiscoGel are even greater than ethanol. For this reason, the risk of infection inside the disc with Discogel injection is very low, but injecting Gentamicin into the disc at the end of the Discogel injection is entirely reasonable.

Q: What is the usual recommended amount of Gentamicin inside the disc?

A: Based on our experience and that of other researchers, the recommended amount of Gentamicin injection into the disc is as follows:

Cervical: 0.2 - 0.4 ml of the 80 mg Amp.

Lumbar: 0.4 - 0.6 ml of the 80 my Amp.

Q: Can we use Steroid injections into the foramen or other epidural space injections at the end of the Discogel injection?

A: This depends on the treating physician's judgment, and from a therapeutic standpoint with DiscoGel, not only is there no contraindication, but it can also assist in controlling acute pain in some cases.

Q: How many hours after Discogel injection the patient is allowed to walk?

A: Typically, and if the patient's condition permits, they can be allowed to walk with caution between one to two hours after completing the injection, and even be discharged.

Q: Is it recommended the use painkillers and anti-inflammatories after DiscoGel injection?

A: The prescription of painkillers and anti-inflammatories after Discogel injection depends on the treating physician's judgment. However, in many cases and based on the patient's condition, we do prescribe these medications for a short period.

Q: Is it necessary to use a neck collar or back support after a Discogel injection?

A: The use of a neck collar or back supports is not necessary after a Discogel injection, but they typically play a good role in controlling potential improper movements and supporting the weak muscles in the area affected by disc herniation. I usually recommend using these devices for my patients for two weeks.

Q: Is it necessary to undergo physiotherapy or other conservative treatments after a Discogel injection?

A: Undergoing physiotherapy, hydrotherapy, and other conservative treatments are not necessary after a Discogel injection, but they can play a crucial role, especially in chronic patients, in correcting muscle and tendon imbalances and increasing the stability of the treated area, which can significantly improve patient responsiveness. In our clinic, we start training specific stretching exercises to patients from the first day of Discogel injection.

Q: If a treated disc relapses after a Discogel injection, can we use Discogel injection again?

A: The recurrence of disc issues after a Discogel injection is very rare. However, if for any reason there is a need for a repeat injection at the same level, it can be performed. Only one of our patients experienced a relapse of sciatic pain two years after a successful lumbar disc treatment with Discogel. Due to the pain's resistance to other interventional methods, he underwent Discogel therapy again and fortunately responded very well to this treatment.

Q: Can Discogel and laser therapy be used simultaneously in disc treatment?

A: Among our patients, there hasn't been a perceived necessity for such a combination. However, if a physician decides to perform both treatments for any reason, it is possible. In theory, it might be better to administer laser therapy first and then proceed with Discogel injection due to the elevated heat generated by the laser.

Q: Can I walk after Discogel injection?

A: For patients with cervical disc herniations, there are no restrictions other than avoiding sudden and uncontrolled neck movements. For patients with lumbar disc herniations, we recommend that sitting time not exceed ten minutes in each session during the first week. However, the patient can sit intermittently between walking sessions. After this initial period, the patient can gradually increase his/her sitting time. But keep in mind that sitting for longer than one hour is detrimental to your spinal column!

Q: Can I drive after Discogel injection?

A: The driving regulations for patients after Discogel injection are exactly the same as the regulations for sitting in these patients. (Refer to the relevant question and answer.)

Q: How soon can sexual intercourse be resumed after Discogel injection?

A: The answer to this question varies from person to person and depends on the location and severity of the disc issue. Starting sexual intercourse is less problematic for individuals with cervical disc herniations, but for lumbar disc herniations, it is recommended to wait at least two weeks after the injection and proceed with caution. It's advisable to choose a position that minimizes movement and pressure for the recovering individual.

Q: What is the most important and helpful modality of physiotherapy for patients with intervertebral disc herniation treated with Discogel injection?

A: The best person to provide input on this would be an expert specialized physiotherapist. However, in our clinic, the most important physiotherapy modalities for these individuals typically include therapeutic exercises and corrective stretches. The stretches start lightly and gradually expand in range of motion, number, and intensity until the individual returns to a normal range.

Q: In case of treatment failure with Discogel, what will be the next step?

A: Interventional therapies, are typically used when conservative treatments have failed, and they can resolve many patient issues. However, if these treatments fail to control the symptoms related to the disc herniation (assuming a definitive diagnosis of intervertebral disc damage is accurate), the likelihood of needing surgical intervention increases.

Q: Can Discogel be injected into the facet joint?

A: There hasn't been any published research on this topic yet, but Professor Jacques Theron has used this injection to control pain stemming from facet joint instability. In our clinic, we have also used this injection in some cases with persistent facet joint pain. Our patients have obtained positive results from the injection, and the neurolysis effects of the Discogel might be the reason behind this effectiveness. Individuals with fixed spondylolisthesis or degenerative facet joint pain may be suitable candidates for this injection.

Q: What are Discogel's mechanisms of action?

A: The action of Discogel mainly is based on: The hydrophilic properties of the ethanol that make the gel soluble and generate the migration of the water from the periphery of the disc (including hernia) towards its center and its micro-fissures (targeted on the initial positioning of the nucleus pulposus and the crack consecutive to its expulsion outside its bed). The bulking agent property linked to the ethyl cellulose that precipitates in the presence of water and which allows to: settle the micro infractions of the disc to create a «flexible soft prosthesis» leading to a consolidation of the weakened parts of the disc; constitutes a physical barrier to inflammatory molecules constituting the preexisting inflammation and pain coming from the disc degeneration. The balance of the gel has been designed at the limit of the solubility of ethyl cellulose in ethanol. In the presence of water inside the disc, the Discogel turns into two phases: a liquid phase (water and residual ethanol) and a solid phase (made of ethyl cellulose and tungsten and trapped ethanol). Once in contact with tissues, the gel becomes solid in its implantation site and plugged into the fissures generated by the exclusion of the nucleus pulposus of the herniated disc. Discogel implant thus allows for preservation of the height of the treated disc and therefore reduces the pain triggered by the herniation.

Q: Do other mechanisms also play a role in the effect of Discogel intervention?

A: Ethanol present in Discogel, by breaking down glycoprotein macromolecules, reduces the space they occupy and lowers the pressure inside the disc (Chemonucleolysis).

Additionally, in chronic degenerative diseases, pain receptor terminals in the peripheral areas of discs increase. This could play a significant role in increasing spinal column pain. The neurolytic effects of ethanol have been well-established. This neurolytic property can also be considered as another mechanism in the effectiveness of Discogel.

In in-vitro studies, it is observed that a very thin membrane forms on the surface of water immediately after contact with Discogel. This membrane can reduce or disrupt the connection of pain-producing mediators with pain receptor terminals, nerves, and blood vessels, thus playing a role in reducing and eliminating pain in patients.

Some of Discogel injection technical points:

The recommended accessories are: Syringes compatible with ethanol (Polycarbonate) / Transfer needle of G19 (from vial towards syringes) / Spinal needles of G22; G20 or G18 depending on the disc at the level of the spine. These recommended accessories are not provided with Discogel®.

During the preoperative visit, the practitioner explains the procedure and the potential complications of the intervention to the patient.

The viscosity of Discogel depends on the temperature. *Avoid administration of the product warmed up above room temperature because the Discogel becomes more liquid and is below optimum viscosity. *To increase its viscosity, Discogel can be refrigerated just prior to injection. *Do not use the vial if the packaging is damaged since sterility may not be guaranteed.

Injection of Discogel inside the disc

In the absence of contraindication for the injection of ethanol gel inside the disc, an injection of the intra-herniated disc of Discogel is accomplished into its center. At the beginning of the injection, the patient may experience a transitional scalding sensation in the region of injection which disappears in the course of injection. To minimize this risk, the product must be injected very slowly. Each partial injection shall be followed by a check of the gel progression on the monitor of the fluoroscope. The injection must be stopped once the gel reaches the outer limit of the disc. Once the product has been injected, the needle is left 2 minutes before being withdrawn from the disc of the patient.

Q: What is the Kambin’s triangle?

A: The Kambin’s triangle, first described by Dr. Parviz Kambin in 1973, is actually a very important

space located between the upper surface of the lower vertebral body, the lateral margin

of the superior facet, and the nerve root.

Q: What is the significance of the Kambin’s triangle?

A: This triangle provides the best space for the passage of the needle tip and its entry into the intervertebral disc.

Discogel CONTRAINDICATIONS AND/OR LIMITATIONS:

Discogel is not indicated for patients known to be allergic to one of the components.

Discogel is not indicated for pregnant women.

Discogel is not indicated for unmatured discs (children).

CAUTIONS:

Particular attention shall be paid to patients in severe depression or any other condition making the interpretation of the pain difficult.

The disc to be treated should represent at least half of its normal initial height to get the most effective benefit.

Do not re-sterilize the vial with its gel.

The vial of Discogel is a single-use device. The risk of reusing it can notably lead to septic risks, evaporation of ethyl alcohol, problems of injectability, and a defect in the effectiveness of the medical device.

Disclaimer: The information provided in this FAQ section is based on the personal experiences of the CSO of our company over the years of using this product. It is solely intended to share these experiences and does not imply any responsibility on the part of our company or the CSO for the analysis and selection of treatment methods. It is essential that relevant specialists, who are engaged in patient care, take responsibility for analyzing and choosing appropriate treatment methods. Our company and its CSO are not liable for the selection of treatment methods or the outcomes obtained.