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Rivista Italiana di Ossigeno-Ozonoterapia 2: 135-138, 2003 Percutaneous Injection of Intradiscal and
Paraspinal Space with O -O Mixture to

Treat Lumbar Disc Herniation
XF. HE*, ZJ. YU, YH. LI, W. LU, QL. ZENG, Y. CHEN, WD. KONG, XL. XU, L. LI, J. PEN.
*Department of Interventional Radiology, Nanfang Hospital, First Military Medical University, Guangzhou; China Key words: lumbar disc herniation; ozone; radiology, interventional; percutaneous Injection
SUMMARY - To evaluate the therapeutic effect and safety for the treatment of lumbar disc hernia-
tion using injection of intradiscal and paraspinal space with O -O mixture. 258 patients were selected in the present study. All patients presented the symptoms of sciatica and low back pain. The diagnosis of thelumbar disc herniation including 70 buldging , 184 protrusion and 4 extrusion was verified by CT or MRimaging. O -O mixture at 30-40 μg/mL and 19~21G puncture needles were prepared. The injection was conducted through the puncture of intradiscal and paraspinal space. For each herniated disc treatment,4~6 mL O -O mixture were injected into intradiscal space and 10-15 ml into paraspinal space. The pa- tients were followed up from 3 to 28 months after treatment. The therapeutic effect showed that 160 pa-tients (62%) had excellent recovery, and 39 cases (15,1%) had significant relief of symptoms, and 59 pa-tients (22.9%) got failure in treatment. No any serious complication occurred. The therapeutic methoddeveloped by using O -O mixture injection in lumbar intradiscal and paraspinal space was a safe and ef- fective one for the treatment of the lumbar disc herniation.
Introduction
Ozone (O , MW=48) is a potent oxidant. It has Clinical Data: Between November 2000 and April more specific gravity, smell, color and easily dis- 2003, 258 patients with diagnostically confirmed solved in water comparing to oxygen. Ozone is de- lumbar disc herniation to enter the study. Their av- composed into O and O within twenty minutes in erage age was 44.6 years old (ranging from 19 to 82 the room temperature. In 1988, Verga, an Italian years old) and patients included 152 male and 106 physician, first injected O -O mixture into para- female cases. All patients complained sciatica and spinal space to treat lumbar disc herniation. Then, low back pains which existed 3 months to 17 years.
Muto modified the technology and injected O -O In physical examination, all patients showed mixture into intradiscal space to treat the same dis- Leasegue Sign positive reaction. Diagnostic verifica- ease in 1998 1. Continuously, the technology has been tion by CT and MRI exhibited the disc herniation or extensively applied in clinic in most European coun- protrusion with nerve root or thecal sac compres- tries including Italy, France, Germany and so on. The sion. Based on the CT or MRI images, the patients therapeutic effectiveness has been certainly recog- could be classified into three subgroups which are nized and accepted by physicians. In 2000, we collab- Buldging (70 cases), protrusion (184 cases), and ex- orated with Ospedale Bellaria Hospital in Italy and trusion (4 cases) 4-6. The disc lesions in all patients oc- set up this project at our hospital in China. At the curred between L4 to L5 and L5 to S1.
same year, we completed animal tests and reported Instrument and facilities: One set of X-Ray ma- this results with its methodology in the Journal of chine with C arm was utilized in the study. The o- Zhong Hua Radiology 2-3. In the present paper, we zone generator (TOG C2) made in Switzerland was will report the technology used and experience adopted. Pure Oxygen was supplied from our hospi- through summarizing 258 cases treated by ozone in- tal. 19~21G chiba needles or 21G needle with multi jection therapy at our hospital in recent years.
side-hole were chosen as the injection needle.
Percutaneous Injection of Intradiscal and Paraspinal Space with O -O Mixture to Treat Lumbar Disc Herniation Treatment Procedure: The patients lay down on the therapeutic response comparing to the other groups negative side with a pillow under their waist. The pa- (table 3). 135 patients selected at random were fol- tient’s negative side leg was kept in stretching posi- lowed up by CT and /or MRI three months after the tion and positive side leg in flection. The anchoring intradiscal injection. Five cases showed a reduction point could be located in the positive side 7 to 9 cm in the size of the herniated disc (figure 1-6). Side re- away from middle line at the level of herniated disc verse effects have been evaluated in this report. No space. Local anesthesia was done by injection of 2% any serious complication such as disc infection, Lidocain. The puncture was conducted via the poste- spinal cord injury and large vessel damage occurred.
rior-outer side with 45-degree angle to reach the le-sion lumbar disc space. When the position of the nee-dle tip was verified , four to six ml of O -O mixture Discussion
with 30-40 μg/ml was injected into the inside of Possible mechanism using O -O mixture to treat lessoned disc. The O -O mixture could be seen dis- the lumbar disk herniation: there exist uncertainty perse into intradiscal space. If the patient had non- about the mechanism using the local injection of container herniated disk, the mixture gas was spread mixture into intradiscal space directly.
into the anterior epidural space. On the imaging vi- Bocci, a physiologist in the Siena University in I- sion, the needle was moved backward into in- taly hypothesized a mechanism 7. Based on the hy- traforaminal space. Thereafter, fifteen ml of O -O pothesis combining the results from our animal mixture and then fifty mg prednisolone were injected tests and human studies, we suppose the following into this space. Drawing the needle out of the skin, possibilities on the mechanism using the local in- we completed the procedure. Generally, the diskgra- jection of O -O mixture into intradiscal space.
phy was not carried out in our routine procedure as it Oxidation of proteoglycan in the nucleus pulpo- will increase the intradiscal pressure . During the in-jection of O -O mixture, some patients felt local hot sus: Ozone is a potent oxidant with half-life span and mild pains but relieved in a short of time. The pa- of twenty minutes in normal temperature. The ox- tient must be kept in bed for at least one day, and in idation process finishes in a very short time. O- home rest for two weeks. Antibiotic and cortisone in- zone causes oxidation of proteoglycan in disc nu- travenous injections were taken for three days.About cleus pulposus and makes its water loss, and then sixty percent of patients accepted second injection of decreases the osmotic pressure of disc tissue. The O -O mixture during the period of one week to ten disc nucleus exhibited dry up, degeneration, necro- days. It’s necessary that the patients avoid acute ac- sis and atrophy, which lightened the compression tivities and heavy burden for six months.
of nerve root. In our animal experiments, thismechanism was verified by the dog disc nucleusappeared dry up, lost elastic features and became rough one month later after ozone injection in the Evaluation of the therapeutic effectiveness was in intradiscal space. The degeneration, necrosis and accordance with the modified MacNab method atrophy of the dog disc nucleus were observed two which classified the effectiveness into success and to three months later, but there was no any disc failure categories (Please see the details from Muto change in the contrast group which received pure and Avella in reference 1). We followed up all pa- tients treated by O -O mixture for three to twenty Table 1 Evaluation of therapeutic effectiveness from 258
eight months after their therapeutic injection. Based cases treated by injection of O -O mixture into intradiscal
on the modified MacNab criteria 1, the clinical effec- space based on MacNab’s criteria
tiveness was evaluated for 258 cases in the presentreport. In the success group, 160 (62,0%) of 258 cases Complete Recovery Significant Relief
No improvement
obtained complete recovery, and 39 cases achieved(15,1%) significant relief of symptoms. In failure group, 59 cases (22,9%) didn’t gain any improve-ment (table 1). The effectiveness has been also eval- uated according to classifications of lumbar disk her-niation (table 2). 61 (87,2%) of 70 cases gained sig-nificant effectiveness in the group of patients suf- Anti-inflammatory action: The back pains and s- fered with buldging disc, and 132 (71,8%) of 184 ciatica are caused not only by mechanical com- cases in protrusion group, as well as 1 (25,0%) of 4 pression of herniated disc to the nerve root, but cases in extrusion group. The best response to the also by non-bacterial inflammation induced by lo- therapy can be seen in the group suffered withbuldging disc herniation, and second level response cal never root edema and effusion resulting from from protrusion disc and extrusion disc with the low- local venous circulation blockage. Meanwhile, the est relief rate. The results showed that the therapeu- inflammatory factors such as histomine, β-protien tic responses were related to the age.There was no d- and glycoprotiens releasing from damaged discal ifference between the groups of the young and the tissue could stimulate the nerve root to cause the middle aged. The patients over 60 years got better pains. It is possible for ozone injection into in- Rivista Italiana di Ossigeno-Ozonoterapia 2: 135-138, 2003 Table 2 Evaluation of therapeutic effectiveness from 258
Table 3 Evaluation of therapeutic effectiveness from 258 cases
cases treated by injection of O -O mixture into intradiscal
treated by injection of O -O mixture into intradiscal space based
space based on the classification of lumbar disc lesion
on the classification of patients’ age
Disc Damage Types
Success/Total Cases
Percentage
Success/Total Cases
Percentage
tradiscal and paraspinal spaces to relief the pains the pain within one to three days. It might be par- by blocking the release of inflammatory factors tially related to this pain relief pathway.
and directly expanding the blood vessels to im- Evaluation of therapeutic effectiveness and prove local circulation, reduce local never root achievement of better therapeutic responses: Accord- ing to MacNab’s evaluation criteria, the success rate Analgesic action: One hypothesis from acupunc- was 75.9% in the present report which was equiva- ture therapy of low back pain and sciatica believes lent to the success rates reported by Muto and that the acupuncture of fine needle into intradiscal Avella 1, Bocci 7. About 26% cases gained symptom and paraspinal spaces stimulate the inhibiting in- relief within 3 days after the therapeutic procedure.
terneurons to produce enkaphalin-like substances The therapeutic effectiveness shows that the thera- which play an important role in the relief of pain.
peutic method creates minimum trauma, no side re- They called the acupuncture therapy as a “chemi- verse effect, and proves to be very economical, and cal acupuncture”. The ozone therapy could relief with high success rate (more than 70%). In order to Figure 1 and 2 CT axial scansbefore (figure 1) and after (fig-ure 2) intradiscal O -O mix- ture injection in a 32 year-oldmale patient and suffering sci-atica on the left for 2 years. Thepatient showed the Leaseguesign positive reaction in hisphysical examination, and lum-bar disk protrusion in L5-S1(figure 1). The patient gainedcomplete relief of sciatica 3months after therapeutic injec-tion, and a reduction in the sizeof the herniated lumbar disk(figure 2).
Figure 3 and 4 CT axial scansbefore (figure 3) and after (fig-ure 4) intradiscal O -O mix- ture injection in a 25 year-oldmale patient and suffering sci-atica on the left for 3 months.
The patient showed the Lasè-gue sign positive reaction in hisphysical examination, and lum-bar disk bulging in L4-L5 (fig-ure 3). The patient gained com-plete relief of sciatica in onemonth after therapeutic injec-tion.
Percutaneous Injection of Intradiscal and Paraspinal Space with O -O Mixture to Treat Lumbar Disc Herniation obtain better therapeutic effect, we have to pay at- of general standard therapeutic protocol according to patients’ individual situation. The volume of ozone Criteria of selecting patients: The low back pain and speed of injection specifically need should be and sciatica are very complex clinical symptoms.
adapted to patients individually. At the same time, we The compression of nerve root by lumbar disc h- need to give patients more psychological guidance erniation or protrusion is one of the many impor- and more education about the therapeutic technology tant factors causing low back pain and sciatica.
before and after this procedure.The therapeutic effec- The factors may include local non-bacteria inflam- tiveness related to aging: Our data of successful thera- mation, degeneration of tendons, turbulence of peutic rate in old group (more than 60 years old) is muscles, dysfunction of small joints and neurologi- better than in groups of young and middle aged, cal deficits. Muto and Avella 1 selected one group which is correspondent to the prior reports 7. It seems of patients with herniated or protruded disc with to be more comfortable to select ozone injection pro- neurological deficit to receive ozone injection cedure for old aged patients than to choose other therapy. The group had “failure” in all patients, in therapeutic strategies such as chemonucleolysis and which the symptoms of seven cases improved for one month, but recurred later on. In our experi-ence, the degree of disc herniation or protrusion is Conclusion
not always related to the degree of back pains andsciatica. In view of this clinical situation, we should Ozone injection therapy for herniated or protruded be very careful in selecting patients to be treated discs is a very wonderful therapeutic procedure that by ozone injection procedure. The patient with can be accepted as an alternative strategy to surgery symptoms related to nerve root compression with in selected patients who went through conservative positive Lasegue’ sign , and bulging or mild to treatments and were unsuccessful for at least three to middle extrusion are the best responsible group to six months. To select correct patients for conducting the therapy. The extrusion excessing ten mm espe- this therapeutic ozone injection, we should see to it cially with spinal canal stenosis doesn’t have good that clinical and neuroradiological indications and therapeutic response in our practice.
contraindications must be followed to achieve good Worsening clinical situation after injection: There results and to avoid complications. Low back pains were thirty eight cases in our reported group had dif- and sciatica caused by lumbar disc herniation or pro- ferent degree symptomatic relief within one to three trusion is a very popular disease in china and the inci- days after injection procedure, but worse pain came dence of new patients per year is around two to three back within five to seven days after first injection.
millions. The conventional treatments in China in- Most patients in this group gained good recovery clude Traditional Chinese Medicine, massage, acupun- when they were given symptomatic treatment and cture, small needle knife and surgery operation. The took propriety rest. Three cases in this group got pain therapeutic effectiveness using ozone injection shows relief through percutaneous discektomy treatment, that the therapeutic method has minimum trauma, no and one case had worse pain relief after six months.
side reverse effects and proves to be very economical, The reason to cause the worsening situation is uncer- and with high success rate (more than 70%) compar- tain, but we postulated that the worse pain might be ing to the chemonucleolysis and percutaneous discec- related to the following factors: a) non-bacteria in- tomy. Our results suggest trying this therapeutic strat- flammatory reaction caused by ozone oxidation to the egy to treat such big population of the patients in disc tissue resulted in the disc pressure increase; b) s- timulation reaction by ozone to nerve root directly; c)impropriety operation during injection such as impro- Acknowledgement
priety injection speed and impropriety injection vol-ume of ozone; and d) the worse pain might be related We greatly appreciate Dr. ZP Wang, Chief Scien- to the psychological responses in some patients. To re- tific Officer in Zephan Biopharmceuticals, Inc. in duce the worse pain happened, the combination pro- USA who assisted us correcting and modifying this cedure should be set up individually by combination Reference
1 Muto M, Avella F: Percutaneous treatment of herniated lumbar disc by intradiscal oxygen-ozone injection. Inetr- taneous discectomy. J. Zhonghua Radialogy 36: 380-382, 2002.
ventional Neuroradiology 4: 273-286, 1998.
6 Tun GJ: Percutaneous Discectomyin Ist Edition. In: GJ Tun 2 Yu Zj, He XF, Chen Y et Al: Influence of ozone on the ul- (Ed): Jiangshu Science and Technology Publisher, Nanjing 2000.
trastructures of nucleus pulposus. J Interventional Radiol- 7 Bocci V: Biological and clinical effects of ozone. Has ozone ther- apy a future in medicine? Bri J Biomed Sci 56: 270-279, 1999.
3 Yu Zj, He XF, Li YR et Al: Animal study for intradiscal in- jection of ozone. J. Zhonghua Radiology (In Chinese) 36: 4 Li MH: Neuro-Interventional Radiology.Shanghai:Shang- hai Science and Techology Litereature Publisher, 2000.
Nanfang Hospital, First Military University 5 Tun GJ, Zhou YC, Sun G et Al: Regulation (draft) of percu-

Source: http://www.ozone-therapy.de/files/dr-he-ozone-nucleaolysis.pdf

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