Back pain is the #1 source of workdays lost to disability globally[1], with approximately 80% of adults experiencing a herniated disc in their lifetime[2] and an estimated prevalence of symptomatic herniated discs of 1-3% of patients[3]. The pain, loss of productivity, and related mental health deterioration resulting from chronic pain including chronic back pain, which is a major contributor to disability and healthcare costs worldwide is an enormous cost to individual sufferers and society. The cost of back and neck pain treatment in the US alone is $134.5B, larger than diabetes at $111B and ischemic heart disease at $89B[4]. Every one of you reading this has likely experienced a debilitating herniated disc or knows someone who has.
But there are major systemic problems causing millions to suffer with debilitating back pain.
- Inconsistent diagnosis, assessment and treatment of complex pain,
- Lack of tools to help patients understand and manage their pain and medications,
- Surgery is very effective, but with serious adverse events. Depending on the region, it is either too frequently used or delayed…neither of which is good
- There has been a lack of innovation and access to minimally invasive technologies for herniated discs.
Back pain and herniated discs are extremely prevalent, with risk factors including age, genetics, and lifestyle. The most common causes of back pain and herniated discs are back strains, sprains, and disc degeneration, which often result from improper lifting, repetitive movements, or age-related wear and tear.
“After conservative therapy (rest, physio, meditation, counselling, pain medication), the only option currently is surgery. There is a ‘therapeutic gap’ between failed conservative care and surgery.” commented Dr. Josh Hirsch, Director of Interventional Neuroradiology, chief of the Interventional Spine Service at Massachusetts General Hospital and former former President of the ASSR, ASNR and the SNIS[5]. While surgery can be very effective for pain relief, it poses risks and high costs.
This article explores the need for innovation in treating contained herniated discs: the problems, the trends towards minimally invasive care, ideal solutions, and the promising treatment modalities within the minimally invasive, image-guided therapy pipeline.
What is Disc Herniation? Clinical Definition and Pathophysiology
Disc herniation occurs when nucleus pulposus material extrudes through annulus fibrosus defects, creating both mechanical neural compression and inflammatory radiculopathy. This pathoanatomic process represents the leading cause of lumbar radiculopathy and a primary indication for spine intervention.
Structural Mechanism of Disc Herniation
Disc herniation fundamentally involves the localized displacement of the gelatinous, highly hydrated nucleus pulposus through tears in the surrounding fibrous annulus fibrosus.¹ This biomechanical failure transforms the disc from an effective load-distributing structure into a space-occupying lesion within the spinal canal, typically occurring at the posterolateral aspect where the annulus measures only 1-2mm in thickness and lacks posterior longitudinal ligament reinforcement.
Dual Pathophysiology: Mechanical and Biochemical Components
Mechanical compression directly affects nerve roots, dorsal root ganglia, and perineural vascular structures. However, chemical irritation through cytokine-dependent inflammatory responses—involving interleukin-1β, interleukin-6, interleukin-8, and tumor necrosis factor-α—may be equally important in generating radicular symptoms.² This dual mechanism explains why simple decompressive strategies don’t always achieve optimal outcomes.
Clinical Manifestations in Spine Practice
Herniated discs produce characteristic radicular pain syndromes including:
- Sciatica and dermatomal pain distribution
- Paresthesias and sensory deficits
- Motor weakness in affected myotomes
- Altered deep tendon reflexes
- Functional disability and activity limitations
Anatomic Distribution and Clinical Significance
While disc herniation affects all spinal levels, lumbar (L4-L5, L5-S1) and cervical regions demonstrate highest symptomatic incidence due to biomechanical demands and anatomic vulnerability. The lumbar spine’s combination of high axial loading and significant range of motion creates optimal conditions for annular failure and subsequent herniation.
Clinical Implications for Treatment Selection
Understanding disc herniation as both mechanical and biochemical pathology provides the foundation for comprehensive treatment approaches. This dual pathophysiology suggests opportunities for targeted interventions addressing both neural decompression and inflammatory modulation—increasingly relevant as therapeutic options expand beyond traditional surgical approaches.³
Inconsistent Care
Oncology has well-defined, evidence-based guidelines which most all practitioners follow. By contrast, contained herniated disc sufferers depend entirely on which provider the patient happens to see: general practitioners, interventional pain specialists, sports medicine and physiatrists, interventional radiologists, orthopedic surgeons and neurosurgeons. Each has different experience, perspectives, and incentives to use different modalities. For example, disc herniations may be managed with non-surgical spinal decompression therapy by some providers, while others may recommend more invasive interventions.
As Dr. Hirsch describes it: “There are gaps in every step along the way. Most importantly, perhaps, is related to delivery. … it’s completely irrational. We should have a best practice approach toward treating these patients.” This is especially true given the wide range of surgeries currently performed for disc herniations and the need to standardize when surgical intervention is appropriate.
Treatment Delays = Reduced Viability + Increased Cost
Treatment delays for herniated discs can cost thousands of dollars per patient and worsen outcomes. In Canada, patients can wait 9-12 months for MRI, surgery and relief. Dandurand et al[6] showed incremental differences in surgery < 60-day vs >60 days to be $11,900/patient due to the additional care needed as viability deteriorates. Ben Israel et al[7] found a $6,664/patient difference between treatment at 10 weeks vs 48 weeks. These authors conclude that increased surgical capacity is justified, but this requires significant capital investment or budget increases. While surgery remains a critical and effective modality, a large number of patients may be able to avoid surgery, shortening the wait lists while maintaining surgical throughput. Innovation in minimally invasive technology has potential for faster and more cost-effective solutions reaching a larger number of patients. Delays in treatment can lead to persistent pain and worse outcomes, including a higher risk of complications.
If pain persists despite initial treatment, patients should seek further medical evaluation to prevent long-term issues.
Dr. Hirsh again: “The biggest challenge [for patients] is the loss of viability for that person as they’re getting better. These kinds of problems generally occur in people of working age, maybe they have kids, maybe they lift things for a living, maybe they sit at a desk. … Really what we’re doing is telling these people, ‘Don’t do anything until you get better’.”
The number of surgeries performed in the USA is double the number performed in Western Europe, Canada and Australia combined, and five times the number in the UK[8], with tremendous incentives for providers to offer surgical solutions. But diagnostic and treatment selection guidelines which do exist can be applied inconsistently. Surgery can be very effective for pain relief but brings adverse event risk, higher cost per case, and for some, trading off short-term pain relief with disc degeneration. Surgical risks also include nerve damage, especially if intervention is delayed or if pressure on the nerve root persists over time.
Professor Alexis Kelekis, Interventional Radiology at National & Kapodistrian University Hospital of Athens, President-Elect of SIO, Fellow of SIR, CIRSE and SpinaFX Medical Advisor has often lectured: “The insurance reimbursement pattern, both in Europe and USA is completely inconsistent. Instead of allowing more percutaneous disc treatments and treat the failures with surgery, it has the tendency to bypass the percutaneous approaches, although it is very clear from the literature that the ladder approach is the most beneficial for the patient. It is evident that diagnostic and treatment selection guidelines can be applied inconsistently. Surgery can be very effective for pain relief but brings adverse event risk, higher cost per case, and for some, trading off short term pain relief with disc degeneration. Post surgery you can be worse than where you started with a risk of 10%, whereas for true minimally invasive technology, you end up where you started without that risk. So fibrotic formation post-surgery, intraoperative injury, all these effects [lead to a] risk of 10% of ending up in a major surgery or a failed back syndrome. Minimally invasive approaches do not have the failed back syndrome issue.”
Drug Use and the Opioid Crisis
Less invasive herniated disc treatments significantly reduce opioid dependency compared to traditional surgical approaches. The opioid crisis has been overwhelming, with spine surgery historically being a major contributor. In addition to opioids, many patients are prescribed pain medications for symptom management, highlighting the need for effective alternatives that avoid reliance on pharmaceuticals.
Dr. Hirsch again: “… there are tremendous problems with the wholesale prescription of opioids for back pain. If we could diminish the number of opioids used in the treatment of back pain, that would be incredible and great for our patients.”
Dr. Allan Brook of Montefiore Hospital in New York: “…there’s a need for minimally invasive techniques that can treat patients outside of using steroids. Steroids have a lot of detractors to it, especially in diabetic patients. Anti inflammatory medication is also commonly used as a conservative treatment option to help manage pain and inflammation before considering more invasive procedures. I can go on forever”.
Less invasive treatment clearly reduces opioid use[9]. The goal is to both manage drug use well, in addition to minimizing or eliminating the need for post operative analgesics, while reducing inflammation to target the source of pain and promote healing.
“True” Minimally Invasive Image Guided Therapy Options
The healthcare industry is rapidly shifting toward minimally invasive procedures that can be performed in outpatient settings rather than hospitals. There is a massive trend towards more minimally invasive modalities, and moving procedures from hospital, to ASC, to clinic procedure rooms. Many of these minimally invasive approaches utilize a small incision, which results in less muscle injury, quicker recovery times, and often allows for outpatient treatment. Although COVID was a major driving force, the trend continues globally, reducing cost per case, while increasing access, and shortening patients’ time-to-relief.
Dr. Hirsch commented: “Contained discs are generally best treated in minimally invasive or percutaneous ways. If [any new] treatment is fairly invasive …I don’t think it’s likely to succeed.”
Dr. Kelekis: “You start with the less invasive and then move to the most invasive. The … more invasive you go, the bigger risks you have. ‘Minimally invasive’ goes with ‘image-guided’. I put the threshold of minimally invasive to minimal suturing. Whatever does not need drainage after it, post-surgery, whatever does not need hospitalization more than 28-48 hours. When you need more than 10 stitches, then it’s not minimally invasive anymore. Minimally invasive treatments specifically for discogenic and sciatic pain have minimal downsides…. percutaneous approaches do not have the failed back syndrome issue.
The Next Generation of Contained Herniated Disc Treatment
The ideal herniated disc treatment should be non-surgical, accessible in simple procedure rooms, and preserve future surgical options if needed, including herniated disk surgery as a last resort. Dr. Kieran Murphy, Chief Medical Officer of SpinaFX Medical, was formerly Director of Interventional Neuro at Johns Hopkins from 1998 to 2008 and since 2008 Director of Image guided Spine Intervention and professor of neuro-interventional radiologist at the University Health Network in Toronto. He has 83 patents and a long history of medical innovation to his name[10]. Twenty years ago, he embarked on a personal mission to fill this “therapeutic gap” for contained herniated discs. He and colleagues sought the ideal solution:
- Non-surgical, percutaneous, image-guided, minimally invasive intradiscal injection with a fine 22g needle,
- No “burnt bridges” …must not prevent future surgery should it be needed, including herniated disk procedures,
- Minimal drug use, no general anaesthetic and minimal post-procedure analgesics needed,
- Maximize access to care by using a simple procedure room and C-arm, avoiding the OR, whether in ASCs, outpatient clinics, military vessels or field hospitals,
- Second line therapy option should immediately follow failed conservative therapy, avoiding delays and surgery whenever possible, and
- Tracking and assessing patients before, during and after intervention…ensuring proper diagnosis, treatment selection and follow-up, especially for patients with lumbar herniated disc, and considering the need for treatments that can address multiple herniated discs in more complex cases.
An Innovative Solution: Intradiscal Ozone/Oxygen Injection
Intradiscal ozone/oxygen injection is just such a solution, appearing to offer similarly effective pain relief to surgery, but significantly shorter procedure and recovery time, less drug use, and extremely low adverse event rates. Intradiscal ozone literature shows ~80% average success rates with ~1% adverse events, and 71% of patients avoid surgery entirely. Kelekis, Murphy et al published results of a 3-site European clinical trial of intradiscal ozone injections vs microdiscectomy surgery in the Spine Journal[11] showing non-inferiority of intradiscal ozone injection to microdiscectomy in terms of pain relief for the trial subjects, providing pain relief for patients suffering from herniated discs. Most significantly, 71% of patients receiving intradiscal ozone avoided progression to surgery. Two major meta-analyses of 7,859[12] and 2,597[13] patients showed average success rate of 62.5-88%% for pain relief and adverse event rates of <1%. In addition, excellent retrospective results are shown at 5 and 10 years [16]. The main mode of action of ozone is suspected to be gentle dehydration and shrinking of the nucleus pulposus, relieving pressure on the nerve roots causing pain[14]. Ozone targets the disc material, shrinking the disc to reduce nerve compression. After the procedure, patients are often advised to use an ice pack to manage inflammation and reduce pain at the treatment site. Overall, ozone therapy has been shown non-inferior to microdiscectomy in reducing pain and improving function in patients with disc-related conditions.
Dr. Hirsch commented: “The evidence of ozone efficacy is real, and there are great metanalyses on it. Its unfortunately something we can’t put our hands on because it is not yet FDA approved”.
Dr. Murphy reflects on his innovation lessons in the quest for minimal invasive solutions: “Inventors are driven by ideas, purpose and engagement. Many people say: ‘They should do something about XYZ problem’. These people don’t realize that they are ‘they’….and [now] We are they”.[15] “I have been working on intradiscal ozone injection for 18 years. And SpinaFX is now dedicated to bringing this innovation to market, filling the therapeutic gap between failed conservative care and surgery for debilitating pain”.
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Patient Education and Empowerment
Empowering patients with knowledge about herniated discs is a vital part of successful treatment. Understanding the causes, symptoms, and available treatment options—including non surgical treatment like physical therapy and pain medication, as well as surgical procedures such as spinal fusion—enables individuals to make informed decisions about their care. Patients are encouraged to ask questions, discuss their symptoms openly, and seek a second opinion if needed. By working closely with their healthcare team, patients can explore a range of herniated disc treatment options tailored to their unique needs, helping to alleviate pain, restore function, and promote healing. Taking an active role in managing a herniated disc not only improves outcomes but also fosters confidence and resilience throughout the recovery process.
References
[1] GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990-2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol 2023: 5: e316-29.
[2] Al Qaraghli MI, De Jesus O. Lumbar Disc Herniation. [Updated 2023 Aug 23]. StatPearls Publishing; [2024 Jan-.](https://www.ncbi.nlm.nih.gov/books/NBK560878/)
[3] Dydyk AM, Ngnitewe Massa R, Mesfin FB. Disc Herniation. [Updated 2023 Jan 16]. StatPearls Publishing; [2024 Jan-.](https://www.ncbi.nlm.nih.gov/books/NBK441822/)
[4] Dieleman JL, Cao J, Chapin A, et al. US Health Care Spending by Payer and Health Condition, 1996-2016. JAMA. 2020;323(9):863–884. doi:10.1001/jama.2020.0734
[5] ASSR – American Society of Spine Radiology, ASNR – American Society of Neuro Radiology, SNIS – Society of NeuroInterventional Surgery
[6] Dandurand C, Mashayekhi MS, et al. Cost consequence analysis of waiting for lumbar disc herniation surgery. Sci Rep. 2023 Mar 18;13(1):4519. doi: 10.1038/s41598-023-31029-5. [PMID: 36934112; PMCID: PMC10024748](https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10024748/).
[7] Ben-Israel D, Crawford E, Fisher C, Dea N, Spackman E, Rampersaud R, Thomas K:” Optimal timing of surgery for symptomatic single-level lumbar disc herniation: a cost-effectiveness analysis”, Abstract Presented 2023 CSS meeting, University of Calgary.
[8] [Agency for Healthcare Research and Quality](https://www.ahrq.gov/data/hcup/index.html).
[9] Orosz LD, Yamout T. The opioid crisis as it pertains to spine surgery. J Spine Surg. 2023 Mar 30;9(1):9-12. doi: 10.21037/jss-22-107. Epub 2023 Jan 4. PMID: 37038425; PMCID: PMC10082423.
[10] Dr. Kieran Murphy: “The Essence of Innovation — Medicine and the Joy of Creativity.” [Dundurn Press 2024](https://www.dundurn.com/books_/t22117/a9781459754034-the-essence-of-invention)
[11] Kelekis A, Bonaldi G, et al, J. Intradiscal oxygen-ozone chemonucleolysis versus microdiscectomy for lumbar disc herniation radiculopathy: a non-inferiority randomized control trial. Spine J. 2022 Jun;22(6):895-909. doi: 10.1016/j.spinee.2021.11.017. Epub 2021 Dec 9. PMID: 34896609.
[12] Steppan, J,, Meaders, T, Muto, M, and Murphy, K: Meta-analysis of the Effectiveness and Safety of Ozone Treatments for Herniated Lumbar Discs. J Vasc Interv Radiol 2010; 21:534–548
[13] Sconza C, Leonardi G, et al: Oxygen-ozone therapy for the treatment of low back pain: a systematic review of randomized controlled trials. European Review for Medical and Pharmacological Sciences, 2021; 25: 6034-6046
[14] Murphy K, Elias G, Steppan J, Boxley C, Balagurunathan K, Victor X, Meaders T, Muto M. Percutaneous Treatment of Herniated Lumbar Discs with Ozone: Investigation of the Mechanisms of Action. J Vasc Interv Radiol. 2016 Aug;27(8):1242-1250.e3. doi: 10.1016/j.jvir.2016.04.012. Epub 2016 Jun 28. PMID: 27363296.
[15] Dr. Kieran Murphy: “The Essence of Innovation — Medicine and the Joy of Creativity.” [Dundurn Press 2024](https://www.dundurn.com/books_/t22117/a9781459754034-the-essence-of-invention) Pg 238.
[16] Buric J, Rigobello L, Hooper D. Five and ten year follow-up on intradiscal ozone injection for disc herniation. Int J Spine Surg. 2014 Dec 1;8:17. doi: 10.14444/1017. PMID: 25694935; PMCID: PMC4325503.