Ozone and herniated disc

 

In a man’s life there are few certainties and one of these is that sooner or later he will suffer from back pain.

One of the most common causes of back pain is represented by a slipped disc. The symptomatic lumbar disc herniation is a degenerative disease of the intervertebral disc that presents a clinical picture characterized by back pain, sciatica or radiculopathy compression and crural limitation or functional impairment. Natural history studies indicate that hernias of the intervertebral disc are reabsorbed often wholly or in part and that the symptoms associated with them regress often with conservative treatments. In asymptomatic people herniated lumbar discs are detected with high frequency imaging. The herniated disc is a dynamic phenomenon, as well as a relatively common condition and has a favourable prognosis in most cases. (Institute of Health Guidelines disc herniation).

 

What is a herniated disc?

To better understand what a herniated disc is, first it is necessary to understand the spinal anatomy . The spine is made up of 32-33 vertebrae (7 cervical, 12 thoracic and 5 lumbar, 5 sacral and 3-4 coccygeal). Each vertebra is numbered with a growing number from top to bottom, C1-C2-C3 … C7-T1-T2-T3 … T12-L1-L2-L3-L4-L5-S1 … the last lumbar vertebra, referred to as L5, is placed over the first vertebra of the sacrum, called S1. Between one vertebra and the other are soft cushions called intervertebral discs, which are named based on  the number and location of the vertebra above and below. For example, the C4-C5 disc is the disc between the fourth and fifth cervical vertebra, while the disc between the fourth and fifth lumbar vertebrae is called  L4-L5 disc.

In the majority of cases, disc herniation occurs in the lumbar region (95% in L4-L5 and L5-S1), followed by cervical region (most often C5-C6, C6-C7) and then by thoracic with only 0.15% / 4.0% of cases. Thoracic discs are in fact very stable and herniations in this region are rare.

 

  The intervertebral discs have a thickness ranging from 6-7 mm to 10-12 mm and a diameter equal to that of the adjacent vertebrae. They act as shock absorbers between one vertebra and the other. When we bend, the disc alters so as to facilitate the movement of the spine. When we skip, the disk alters so as to allow alleviation of the impact on the vertebrae. This deformability of the disc is related to its structure: a core part soft and rich in water, called the nucleus pulposus, and a peripheral part made of material more resistant and fibrous, called the annulus fibrosus.

 

For reasons not entirely clear (overload? Individual predisposition? Incorrect posture? Smoking? …) The outer fibrous may lose its ability to withhold the nucleus pulposus. This leads to leakage of the nucleus and eventual  disk herniation.

Often, even with the annulus fibrosus  torn, the disc may not always break and remain intact although distorted, this is called a disc protrusion or bulging. However, when the fibrous ring is broken, it is called herniated disc. In this case the content of the gelatinous disc protrudes to move into the spinal canal, sometimes pressing directly against the nerve roots.

 

To be precise we should avoid talking about herniated discs in many cases. The correct description for all deformations of the disc should be disc protrusion. In turn, the protrusion is divided into harmonic or circumferential protrusion (bulging) when the disc is enlarged to its circumference (similar to a flat tire); a focal protrusion is when the disk has a deformation in a single point. This condition is commonly called herniated disc.

In simple terms and also the doctor’s, one speaks of ‘protrusion’ when the deformation  is minimal, ‘small hernia’ when the deformation is a bit ‘larger, ‘hernia’ when the deformation is even bigger,  ‘massive hernia’ is when, even the doctor is surprised at the size of the hernia! In fact the term hernia should only define  conditions in which the nucleus pulposus has leaked from the disk lacerandone fibers (figure n°3 above).

This explains the confusion that sometimes leads us to say … “I thought it was a hernia, instead it was a protrusion” …… “lucky you, I was diagnosed with a protrusion but the professor then told me it was a hernia!” … in reality, both patients have  a protrusion also called hernia, or better and more clearly, have a deformation of the intervertebral disc.

All disc deformations can cause inflammation and pain, be it small, very small or very large. Often it is not so much the size of the deformation of the disc but the area, this  being a classic example of the   intraforaminal area. As the nerve exits the vertebral canal, a protective tube set around the spinal cord and nerve roots forms protection, through a hole with relatively small bony walls and the presence of even a small compression here may determine major pain. The same deformation (protrusion or herniation, if you prefer) to another location may go unnoticed and without symptoms.

In order to simplify this site we will use the term ‘hernia’ as is understood in the common sense.

 

Why do I have pain?

The laceration of the disc causes the release of chemical mediators of inflammation that may cause severe pain even without direct compression of the nerve roots: this is radiculitis chemistry, that of an inflammatory process involving the roots of the nerves at the point at which these protrude from the spine.

When the  nerve is inflamed at its origin, pain can be felt in every point  where the nerve arrives. The painful areas – foot, arm or leg – can be perfectly healthy but the nerve communicates to the brain incorrect information because the connecting impulses represented by the same nerve transmits abnormal data. The pain is in the foot but the cause of the pain is in the back. Some patients may feel pain around the back or neck, while others  feel  pain at the periphery of the leg or arm. This is characteristic of each individual compression and, above all, the number and quality of nerve fibers affected by the inflammation.

Inflammation is the cause of pain from herniated discs, it hurts when the nerve is inflamed, not when it is pinched. A pinched nerve that is not inflamed can give a sense of an electric shock, similar to  when you knock your elbow. A nerve can be both pinched and inflamed,  in which case the pain is more intense.

 

This explains the use of anti-inflammatory drugs to treat pain caused by a herniated disc and protrusions, but, it also explains why it is possible to have a herniated disc and not experience pain. Many people  have disc protrusion or herniation of the column without ever experiencing any pain.

Based on this we see why,  nowadays,  there is  a much more conservative, non-surgical, approach towards herniated discs.

 

Frequency

Herniated disks are more common in people aged between 30 and 50 years, when the core is still well hydrated and gelatinous. With age the nucleus pulposus changes, it becomes progressively dehydrated and the risk of hernia formation is reduced. The prevalence in a lifetime, of lumbar disc herniation has been estimated  1 to 3% in Western countries. In 1999, the ISTAT survey on health status in Italy indicated that 8.2% of the population was reported to be suffering from “lower back pain” (7.3% males and 9.3% females).

 

Natural history of a herniated disk

The symptoms of a hernia may resolve spontaneously or with conservative treatment, a number of diagnostic imaging studies have shown that, in a high percentage of cases, herniated discs partially or completely resolved.

The improvement is rapid in the first three months and is attributed to mechanisms of cellular re absorption mediated by cytokines without fibroblastic reaction. A herniated disc is a dynamic phenomenon, as well as being a relatively common condition and there is a favorable prognosis in most cases. 95% of patients with crippling back pain are able to return to work within three months after the onset of symptoms without resorting to surgery.

It is uncommon for a herniated disc to cause an extensive compression, which would  be a clear indication of the need for surgery. These lesions regress spontaneously or frequently  present an improved prognosis with conservative treatment,  depending on  the size of the hernia and the extent of migration from the disc space. Even neurological motor deficits caused by a lumbar herniated disc (with the exception of cauda equina syndrome and progressive loss of motor function) would still favor a more natural approach. (Saal JA. Natural history and non operative treatment of lumbar disc herniation. Spine1996; 21 (24 Suppl): 2S-9S.)

 

Symptoms

Patients may complain of pain, varying in intensity, tingling or a burning sensation, or sensibility to touch. Pain may be reduced, or  absent, and may sometimes present as numbness. The areas displaying the symptoms are linked to the herniated zone or protrusion.

Herniated lumbar disc  

The symptoms occur in the lumbar region of the back, buttocks, thighs, and may spread to the foot and also toes. The sciatic nerve is the most commonly affected nerve (pain in the leg, back, ankle or toes)and more rarely  the femoral nerve ( Anterior thigh pain extending to the knee ).

Herniated cervical disk

Symptoms can affect the head, neck, scapula, shoulder, arm and hand.

 

Red lights (red alert signs)

In the history and clinical examination of a patient with back pain and /or nerve root pain symptoms can be caused by systemic diseases, inflammatory, neoplastic  or infectious disease that involve the spine. Patients who, in addition to lower back pain, show signs of the so called red lights (red alert signs) as listed below, should be extremely concerned:

1. extensive neurological weakness  and /or progressive

2. history of cancer, unexplained weight loss, ongoing fatigue

3. fever

4. constant pain worsening at night;

5. recent trauma, prolonged intake of steroids, osteoporosis;

6. the clinical features of ‘cauda equina’ syndrome with anesthesia in the perineal region, retention or urinary incontinence and /or fecal incontinence, bilateral weakness of the lower limbs;

Only a thorough physical examination can rule out a condition more serious than a herniated disc!

 

Risk Factors

The following conditions are considered as high risk factors : sedentary occupations, physical inactivity, overweight, height, prolonged driving  and constant vibrations, physical jobs especially if involving constant manual lifting of heavy loads and pregnancy.

 

Diagnostic examinations: CT or MRI?

Given the high rate of spontaneous remission shown in the clinical picture by  following conservative treatment, in cases where there are no ‘red alert’ signs, it is recommended to wait at least 4-6 weeks after the onset of symptoms before proceeding with diagnostic images. CT and MRI are now similar in terms of diagnostic accuracy but MRI has the advantage of not exposing the patient to radiation.

The physician responsible for the clinical management of the patient must correlate information from reports of diagnostic imaging to the clinical situation, explaining that the radiological finding of symptomless disc protrusion is common in the general population.

The use of intravenous contrast agents with a CT or MRI is indicated for a diagnosis of lumbar disc herniation only in patients who have undergone surgery, and only in cases where studying without enhancement of contrast is inconclusive.

 X-ray of the spine is not a routine examination in patients with nerve root pain, except in cases of suspected spinal fracture or suspected ankylosing spondylitis. We do not recommend carrying out routine electrophysiological tests.

 

Ozone Therapy

Brief ‘history’

The treatment of hernias and disc protrusion with Ozone was introduced inItaly from 1980, thanks to an orthopedic surgeon, Dr. Cesare Verga. This treatment involved infiltration of the paravertebral muscles with a very high volume of gas. The therapeutic results were disputed by the scientific world, but patients healed nevertheless …

In 1984, Dr. Verga presented his findings at a medical conference, receiving not exactly high praise, but, patients continued to heal …

From the word of mouth of healed patients, followed the curiosity of physicians.

Starting in the 90’s the first scientific articles began to appear in medical journals with case studies,  increasingly more numerous. Much of the medical world still considered the technique to be ineffective, nevertheless patients continued to heal …

Ozone therapy  moved forward into the early 2000’s with many impressive case studies, thanks to the tireless work of a neuroradiologist from Brescia, Dr. Matteo Bonetti, motivated by an unquestionable authority in the world of neuroradiology, Prof. Marco Leonardi. Over a period of 10 years, hundreds of articles have been published with  satisfactory collected data criteria, and statistical analysis of the results: in a word, scientific.

The health world, while understandably reluctant to accept a therapy based on the use of a gas, became increasingly more curious – through word of mouth it united in sending patients to our Ozone therapy clinics via medical colleagues.

The increasing uptake of ozone then led to its use  by many  non-medical personnel,  beginning  a series of issues relating to the side effects and this  led to a letter being circulated by the Ministry of Health Sirchia, which led  to its suspension inItaly. A few months after the initial suspension , followed a ministerial circular from the Lazio Regional Administrative Court and a fundamental Circular for  the Lombardy Region ‘authorizing’ its use – exclusively  in doctors’ surgeries – and treatment by medical personnel only.

Over the years  the author of the site developed a more detailed analysis of side effects associated with the administration of Oxygen-Ozone mixtures for the treatment of herniated disc protrusion and, more generally, any infiltrative treatment. The author then came out with various articles reporting the causes of any major side effects and the steps to be taken to avoid them – different techniques being revised in a scientific manner and subsequently demonstrated to show that doses and volumes of Oxygen-Ozone must fall within certain parameters  simultaneously to obtain resolution of the pathological picture and the virtual absence of any side effects.

Now, with great personal pleasure  I  see that, seven years after  the publication of my first article about side effects, there have been no reports of major side effects in the whole group of doctors who identify with the Italian Federation of Ozone Therapy (FIO).

 

Techniques

In recent years there have been numerous courses and conferences inItaly and the rest of the world aiming to form a scientific culture surrounding the world of ozone therapy. Currently there are three techniques being used to treat a herniated disk:

1. Paravertebral

2. Intraforaminal with radiological guidance (luminance amplifier, TAC)

3. Intradiscal

While in many cases the symptoms overlap, it is possible to treat a hernia or protrusion with more than one technique, a medical expert can suggest the best method based on the morphology and location of the hernia, as well as symptoms and characteristics of the patient.

 

 1. Paravertebral techniques

Using the vernacular, the “mother” of all treatments is injecting  ozone into the spinal column. No doubt this is the most commonly used  method.  It’s relative ease has a high therapeutic efficiency, minimal side effects (with the correct technique!) and few contraindications.

The patient must be placed on a bed with his/her  back facing upwards. Once  the site of the hernia or protrusion has been identified, the  administration of a mixture of oxygen-ozone, follows, to correspond with the  muscles positioned laterally to the spine. Administration is through very fine needles –  not usually particularly painful.

Indicated are many spinal column pathologies:

• herniated discs

• disc protrusion

• arthritis

• spinal canal steno sis

The apparent simplicity of the Ozone/Oxygen technique should not, however, disregard :

• thorough disinfection

• use of disposable materials

• use of 20ml syringes only, 50-60ml syringes must not be used risking inadequate dosage or a quantity  potentially dangerous for the patient.

• the need to remain for a few minutes on the bed.

The percentage of pain resolution achieves  75-80% of positive results.

 

2. Intraforaminal techniques

Treatment with a mixture of Oxygen-Ozone in the intraforaminal requires the use of an image intensifier or  TAC for the precise positioning of the needle at the point at which the inflamed nerve exits from the spinal canal. The treatment is performed after a thorough disinfection of the skin, followed by a local anesthetic  -using  ice spray. Rarely is it painful for the patient,  after about 15-20 minutes he/she can return home.

This technique represents the evolution and the improvement of traditional paravertebral injections. The ozone arrives exactly on the nerve roots suffering due to the hernia or protrusion. The use of X-ray equipment makes it possible to ensure the constant accuracy of this technique.

The technique is important for several reasons:

1.faster resolution of the pain picture

2. administration of ozone in the  immediate vicinity of  the spinal ganglion nerve, and/or other anatomical structures affected by the origin of pain caused by disc compression.

3. possibility of treatment and radiological documentation of the diffusion of Oxygen-Ozone, thus avoiding any complication.

4.the  accurate execution even in areas subverted by the presence of scars due to previous surgical procedures (for example: the area of residual pain after surgery)

Usually we perform 4-5 infiltrations with intervals of one to two weeks, or perform an initial infiltration intraforaminal followed by the classical cycle of infiltrating paravertebral .

The percentage of pain resolution achieves  85% positive results.

 

Surgery

Geographic variation for lumbar disc herniation  surgery reflects the uncertainty surrounding surgical procedures.Italy  carries out, on average  about thirty surgical procedures per year on diagnosed lumbar disc herniation, which  average  in the period1999-2001 amounted to5.09 per 10,000. The regional rates based on age and sex vary widely, from6.87 in Lombardy to2.52 per10,000 in Calabria – so there are some regions with a higher percentage of operations on hernias than others.

The cauda equina syndrome from a herniated intervertebral disc is an absolute indication for discectomy surgery to be performed urgently within 24 hours from the onset of symptoms. The appearance of worsening motor deficit in a patient with a diagnosed herniated lumbar disc requires surgery to be considered, even if does not represent an absolute indication. 

For elective indications covering more than 95% of surgical case studies, there must always be a correlation of

the symptoms reported by the patient (pain radiation and numbness),

the clinical objective (clinical trials and reflections) 

instrumental diagnostic imaging confirming the level of disc involvement.

If this consistency is satisfied, it is recommended that surgery be considered in the presence of all the following criteria:

• symptom duration equal to or more than six weeks

• persistent pain unresponsive to analgesic treatment

• failure, in the opinion of both the surgeon and the patient, regarding the efficacy of conservative treatments  properly carried out.

It is of fundamental importance that the patient is involved in the decision-making process and adequately informed about the natural history of the pathology and treatment options.

A further reason for caution to be taken before surgery is the advanced age of the patient, which is a factor of an unfavorable prognostic  postoperative outcome. The presence of severe widespread degenerative pathologies of the spine or peripheral neuropathies represents a contraindication to discectomy.

 

Which surgery?

There is good evidence that the standard discectomy is more effective than conservative treatment for pain relief but the effect is limited in time and tends to disappear within four years of surgery. The microdiscectomy is as effective as the standard discectomy. There is insufficient evidence on the effectiveness of automated percutaneous discectomy and interventions by laser and coblation.

Whereas the effect of  a discectomy after some time is comparable to conservative treatments and disk herniations are reabsorbed spontaneously – healing with high frequency, it is essential that the patient is given a full briefing on the natural history of the condition, the better effectiveness of time-limited surgical treatment compared with conservative treatment and the risks for surgery and treatment options.

There is evidence that better  patient information improves the overall prognosis of the condition. The patient must actively participate in the choice of treatment strategy also bearing in mind  their lifestyle and preferences.

 

Surgical complications

Spine surgery is not without dangerous intra and postoperative complications, such as discitis, damage to  nerve roots, vascular complications and immediate or delayed spinal instability. Overall:

• risk of reoperation is equal to 3-15%,

• risk of mortality 30 days after surgery varies between 0.5 and 1.5 per 1,000 patients operated on (!)

• impact of operative complications is 3-6%,

Vertebral instability, noted by irregular movement between one or more vertebrae  can cause intermittent radicular compression and represents a major cause of failed-back syndrome. Impact increases progressively with subsequent reoperations with over 60% in patients undergoing multiple revisions.

 

Herniated discs recurrence after surgery

Retrospective studies based on data from hospital information systems, conducted in Finland, in patients operated on for lumbar disc herniation estimated cumulative risk of reoperation at nine years, or 18.9% and follow-up actions after the first reoperation ten years equal to 25 . 1%,  it is then understood that any subsequent reoperation increases the risk of further intervention. Other sources report that the rates of reoperation after lumbar disc surgery vary widely from 3% to 15%.

There is currently no data on Italian hospitals. (!)

 

How many surgeries are performed in Italy and worldwide?

There are very wide international variations in rates of surgery for lumbar disc herniation, dating back to the eighties: from 10 per100,000 in theUK to more than 100 per100,000 in theUSA.

In theUSA, from 1979 to1990, a33% increase was noted  in rates of lumbar spine surgery. The rates increase linearly with the number of neurosurgeons and orthopedic surgeons per person and oscillate  widely among the various federal states.

Within the Maine Lumbar Spine Study, the relation between the  outcome and volume of work performed has been investigated. In contrast to what is known of other surgical procedures, it is very interesting to note that the results of treatment in patients operated on by surgeons in areas with lower intervention rates were significantly better than in patients of the areas with high rates.

InItaly, the average rate of surgery in the period1999-2001amounted to5.09per 10,000. The standardized rates ranging from 6.87 to2.52per10,000 inLombardy andCalabria. The time variability in the three years was low: the total number of operations increased from28,231 in1999 to30,243 in2001.

With a wider selection of cases which also includes lower back pain, sciatica, lumbar spondylosis, spondylolisthesis and canal stenosis as primary diagnosis, the average rate of surgery for lumbar disc herniation was equal to 6.1 per10,000 in1999-2001, ranging between8.12and3.40per10,000 inthe Lazio region inSardinia.

 

Geographic variability of surgery on herniated discs reflects the uncertainty on the optimal use of procedures as well as the magnitude of “medical disagreement” of surgery  indications.

Epidemiological studies suggest that, in lumbar disc herniation surgery, intervention appropriateness  and postoperative outcomes go hand in hand.

 

Which technique should I choose?

It  is important to have confidence in your chosen doctor. The “pilgrimage” between different doctors to compare the various opinions, while understandable from a rational point of view, may produce  extreme confusion.

Because many people suffer from back pain or sciatica it is easy to find many people, friends and acquaintances  suggesting many treatments widely among themselves: “A friend of mine is going to be  healed by Dr. Vattelapesca “,” going to my physiotherapist  John “,” my cousin used ozone -therapy “,” my father tried the nitrogen “,” I did not do anything and after three weeks I was better. “!

 

But what do I do?

In the absence of Red lights (red alert signs) a smart choice to start from would be minimally invasive techniques ,continuing  with more invasive techniques if there is no response. This approach is the criterion suggested by major scientific societies. When choosing a treatment (conservative or surgical) always ask the success rate and recurrence rate, most importantly, what are the complications associated with different techniques.

A proper clinical evaluation with thorough examination and further evaluation of radiological investigations (recent!), accompanied by  precise information about the different treatment options form the best ‘business card’ from a scrupulous doctor.