ORIGINAL RESEARCH

Sciatica: Treatment with Intradiscal

and Intraforaminal Injections

䡲 VASCULAR AND INTERVENTIONAL RADIOLOGY

of Steroid and Oxygen-Ozone
versus Steroid Only1
Massimo Gallucci, MD
Purpose: To prospectively compare the clinical effectiveness of in-
Nicola Limbucci, MD
traforaminal and intradiscal injections of a mixture of a
Luigi Zugaro, MD
steroid, a local anesthetic, and oxygen-ozone (O2-O3)
Antonio Barile, MD (chemodiscolysis) versus intraforaminal and intradiscal in-
Emmanouil Stavroulis, MD jections of a steroid and an anesthetic in the management
Alessandro Ricci, MD of radicular pain related to acute lumbar disk herniation.
Renato Galzio, MD
Carlo Masciocchi, MD Materials and Medical Ethical Committee approval and informed consent
Methods: were obtained. One hundred fifty-nine patients (86 men,
73 women; age range, 18 –71 years) were included and
were randomly assigned to two groups. Seventy-seven pa-
tients (group A) underwent intradiscal and intraforaminal
injections of a steroid and an anesthetic, and 82 patients
(group B) underwent the same treatment with the addition
of an O2-O3 mixture. Procedures were performed with
computed tomographic guidance. An Oswestry Low Back
Pain Disability Questionnaire was administered before
treatment and at intervals, the last at 6-month follow-up.
Patients and clinicians were blinded as to which treatment
was performed. Results were compared with the ␹2 test.

Results: After 6 months, treatment was successful in 36 (47%)

patients in group A and in 61 (74%) patients in group B.
The difference was significant (P ⬍ .01).

Conclusion: Intraforaminal and intradiscal injections of a steroid, an

anesthetic, and O2-O3 are more effective at 6 months than
injections of only a steroid and an anesthetic in the same
sites.

娀 RSNA, 2007

1
From the Departments of Radiology (M.G., N.L., L.Z.,
A.B., E.S., C.M.) and Neurosurgery (A.R., R.G.), University
of L’Aquila, S Salvatore Hospital, Coppito, 67100 L’Aquila,
Italy. Received November 28, 2005; revision requested
January 18, 2006; revision received March 1; accepted
April 4; final version accepted, June 19. Address corre-
spondence to N.L. (e-mail: niclimb@libero.it ).

姝 RSNA, 2007

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VASCULAR AND INTERVENTIONAL RADIOLOGY: Sciatica: Oxygen-Ozone versus Steroid Injection Gallucci et al

L
ow back pain and sciatica are said ness of intraforaminal and intradiscal in- imaging and clinical findings. Discogra-
to affect most of the population at jections of a mixture of a steroid, a local phy was performed only in few patients
least once during a lifetime (1). anesthetic, and O2-O3 (chemodiscolysis) at the beginning of our practice, but we
Nevertheless, the natural history of versus intraforaminal and intradiscal in- abandoned this procedure. According
lumbar disk herniation is favorable: Im- jections of a steroid and an anesthetic in to our experience and the literature
provement of symptoms is the norm, the management of radicular pain related (21), discography does not add impor-
and most episodes resolve spontane- to acute lumbar disk herniation. tant information because only patients
ously or after conservative therapy with discogenic pain are identified with
(2,3). The natural history of lumbar this procedure. Moreover, a contrast
disk herniation has been elucidated by Materials and Methods agent injected during discography fills
means of serial imaging studies, which the potential intradiscal space that may
showed spontaneous clinical and ana- Patients be used for therapeutic agents (ie, ste-
tomic resolution in 67%–76% of pa- The study protocol was approved by the roids and O2-O3), which prevents injec-
tients after 1 year (4–8). Therefore, an Medical Ethical Committee of our insti- tion of the optimal amount of these
invasive approach is reserved for pa- tution. We obtained informed consent drugs. However, in our experience,
tients failing to respond to conservative from all patients. From March 2004 to O2-O3 itself has a discographic effect.
treatment. April 2005 (14 months), we treated 159 The 159 enrolled patients were all
Surgery is less invasive than it was patients (86 men, 73 women; age range, the ones who met our criteria and who
in the past because of new microsurgi- 18 –71 years) with lumbar disk hernia- were treated during the study time. The
cal techniques. However, its success tion (L3-4, 23 patients; L4-5, 61 pa- patients were randomly assigned to one
rate is not optimal: Pain resolution is tients; L5-S1, 75 patients) and radicular of two groups (A and B) by means of a
present in no more than 80%– 85% of pain. The mean duration of radicular randomization grid. Group A included
patients (9), and a failed back surgery pain at the time of treatment was 15 77 patients (43 men and 34 women;
syndrome develops in 10%– 40% of pa- weeks. Preliminary clinical evaluation mean age, 41 years), and group B in-
tients (10). was performed by two experienced neu- cluded 82 patients (45 men and 37
In the past decades, many new min- rosurgeons (R.G., 25 years experience; women; mean age, 40 years) (Table).
imally invasive image-guided interven- A.R., 10 years experience). Moreover, Group A underwent intraforaminal and
tional techniques have been developed all patients underwent computed to- intradiscal injections of 2 mL of triam-
to reduce the need for surgery and to mography (CT) or magnetic resonance cinolone acetonide (40 mg/mL Kena-
improve the quality of life of patients (MR) imaging. cort; Bristol-Myers Squibb, Sermoneta,
requiring systemic drugs (11–13). Yet, Inclusion criteria comprised mono- Italy), with 1 mL injected in the epidural
few of these treatments have been radicular pain, lumbar disk herniation space and 1 mL injected inside the
tested in controlled randomized studies. on CT or MR images, herniation site disk, and 2– 4 mL of 2% ropivacaine
A recently proposed treatment for congruous with the neurologic level, (Naropina; AstraZeneca, Basiglio, It-
lumbar disk herniation is chemodiscoly- and Oswestry Disability Index (20) aly), about 2 mL injected in the epidural
sis by means of percutaneous intradiscal greater than 30%. All patients com- space and 1 mL injected inside the disk.
oxygen-ozone (O2-O3) injection. The ef- plained of pain for at least 8 weeks. Group B received the same treatment
fectiveness of this treatment has been They had received conservative therapy with the addition of an O2-O3 mixture,
tested in large clinical studies, findings (physiotherapy and/or nonsteroidal an-
of which have shown a positive outcome tiinflammatory drugs and/or intramus-
in 70%– 80% of patients (14–18). Find- cular steroids) for 2– 4 weeks, with no Published online before print
ings of a randomized controlled study or poor clinical improvement. 10.1148/radiol.2423051934

(19) to assess the effectiveness of in- Exclusion criteria comprised preg- Radiology 2007; 242:907–913
traforaminal injection of O2-O3 versus nancy, referred allergy to proposed
Abbreviation:
steroids have been recently published, drugs, and major neurologic deficits. CI ⫽ confidence interval
with O2-O3 injection being more effec- We also excluded any patients who had
tive than steroids. clinically diagnosed syndromes that are Author contributions:
Guarantors of integrity of entire study, M.G., C.M.; study
The purpose of our study was to pro- able to mimic the symptoms of a lumbar
concepts/study design or data acquisition or data analy-
spectively compare the clinical effective- disk herniation: facet syndrome, sacro- sis/interpretation, all authors; manuscript drafting or
ileitis, bone lesions (infective, inflam- manuscript revision for important intellectual content, all
matory, or neoplastic), or previous authors; approval of final version of submitted manu-
Advance in Knowledge spine surgery. script, all authors; literature research, M.G., N.L., A.R.;
䡲 Perigangliar and intradiscal injec- The level to be treated was chosen clinical studies, M.G., N.L., A.R., R.G.; experimental stud-
tions of oxygen-ozone and ste- on the basis of results from a neurologic ies, M.G., N.L., L.Z., A.B., E.S.; statistical analysis, N.L.,
L.Z., A.B., E.S.; and manuscript editing, N.L., C.M.
roids are more effective than ste- examination performed by the neuro-
roid and anesthetic injections. surgeons and correspondence between Authors stated no financial relationship to disclose.

908 Radiology: Volume 242: Number 3—March 2007

VASCULAR AND INTERVENTIONAL RADIOLOGY: Sciatica: Oxygen-Ozone versus Steroid Injection Gallucci et al

with an ozone concentration of 28 12 (7.6%) patients by using a 9- or the nucleus pulposus. When the needle
␮g/mL . We injected 5–7 mL of O2-O3 at 15-cm 22-gauge spinal needle. The side entered the disk, a soft resistance was
intraforaminal level (mean, 6.5 mL) and of the injection was chosen on the basis felt. Before injection inside the disk, a
5–7 mL of O2-O3 inside the disk (mean, of the main location of symptoms. CT scan was used to confirm that the
5.8 mL). We chose a steroid injection After local anesthesia, the needle needle tip was inside the nucleus pulpo-
for comparison because of the effective- was advanced to the intraforaminal sus to avoid injection into the outer an-
ness of this treatment and the similar space, with an angle usually between nulus (Fig 1c). The drugs were slowly
degree of invasiveness of both interven- 45° and 60°, following a needle tip posi- injected inside the disk.
tions (22,23). Patients were blinded as tion with use of CT scans (Fig 1a). After In group B, O2-O3 was injected imme-
to whether they had received O2-O3 as confirmation of the position, the drugs diately after anesthetic and steroid injec-
part of the treatment. were injected at this level (Fig 1b). The tions. A mild resistance was usually felt
needle was subsequently advanced to- during O2-O3 injection; if the resistance
Procedures ward the disk to inject the drugs inside was strong, the injection was stopped. A
The procedures were always performed
on an outpatient basis by two neurora- Figure 1
diologists (M.G., 8 years experience in
spinal interventions; N.L., 2 years expe-
rience). Before every procedure, the
patients received premedication with
intravenously administered 1 g of cefa-
zoline (Totacef; Bristol-Myers Squibb),
30 mg of ketorolac (Toradol; Recordati,
Milan, Italy), and 50 mg of ranitidine
(Ranidil; Menarini, Florence, Italy). All
procedures were performed with CT
guidance (Somatom Plus 4; Siemens
Medical Systems, Erlangen, Germany)
with the patient in the prone position.
Transverse scans (3 mm thick) were
used to choose the needle path and to
calculate the entry point.
The O2-O3 gas mixture was
achieved by using an ozone generator
(OZO2 Futura; Alnitec, Cremosano, It-
aly). Intradiscal and intraforaminal in-
jections were administered with a para-
vertebral approach in 147 (92.4%) pa-
tients and an interlaminar approach in

Patient Characteristics
Characteristic Group A Group B

No. of patients 77 82
Men/women 43:34 45:37
Mean age (y) 41 40
L3-4 herniation 12 (16) 11 (13)
L4-5 herniation 27 (35) 31 (38)
L5-S1 herniation 38 (49) 40 (49)
Mean ODI score at Figure 1: Transverse CT images of consecutive phases of O2-O3 chemodiscolysis with right paravertebral
baseline (%)* 57.5 58.4 approach at L4-5 level in 65-year-old man in prone position. (a) Entry path with a 45° angle. (b) Tip of the
Mean surgical time (min) 27 30 needle (arrow) is in periradicular position. (c) Needle is advanced inside the disk following the same path; the
Note.—Unless otherwise indicated, data are numbers position is confirmed by evidence of needle tip (arrow). (d) Distribution of gas after intradiscal and periradicu-
of patients. Data in parentheses are percentages. lar injections; the needle is still on site (white arrow). The O2-O3 mixture is distributed inside the disk (ⴱ) and
* ODI ⫽ Oswestry Disability Index. in epidural space (black arrow).

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VASCULAR AND INTERVENTIONAL RADIOLOGY: Sciatica: Oxygen-Ozone versus Steroid Injection Gallucci et al

CT scan was acquired to evaluate even- vented injections into or puncture of the Low Back Pain Disability Questionnaire
tual complications and O2-O3 distribu- dural sac (Fig 2). (24) to all patients the day of the proce-
tion. O2-O3 delivery was considered satis- Overall, the average injected vol- dure, 2 weeks later, and 3 and 6 months
factory when the gas was homogeneously ume in group A was 3 mL at intrafo- later. Data about possible complications
distributed inside the nucleus pulposus raminal level and 2 mL inside the disk. were also collected. The questionnaire
and when it showed diffusion in the epi- In group B, the average injected volume was administered by two individuals
dural space, with involvement of the peri- was 9.5 mL at the intraforaminal level (E.S., L.Z.) who were blinded to patient
ganglionic space (Fig 1d). If epidural diffu- and 6.8 mL inside the disk. The average distribution in the two groups. During fol-
sion was absent or poor (gas only near injected volume of O2-O3 in group B low-up, the questionnaire was adminis-
the root and not in the epidural space, or patients was 12.3 mL. Mean surgical tered by phone. Every patient was ran-
vice versa), the needle was pulled out of time was 27 minutes (range, 12– 40 domly assigned to one of the two clini-
the disk and was repositioned deeper in minutes) for group A and 30 minutes cians, with each clinician administering
the foramen or in the epidural space, and (range, 12– 45 minutes) for group B. Af- the questionnaire to each of the patients
O2-O3 was injected again. Epidural gas ter treatment, the patients rested in the in the subset over the full course of follow-
diffusion could help confirm the proper supine decubitus position for 2 hours. up. Clinician A (E.S.) interviewed 37
positioning. After this last evaluation, the At discharge, the patients were advised (48%) group A patients and 39 (47%)
needle was removed and the procedure to take a 4-day rest and to gradually group B patients. Clinician B (L.Z.) inter-
was concluded. The interlaminar access resume motion activity. viewed 40 (52%) group A patients and 43
was only performed when the lumbar (52%) group B patients.
bone anatomy made needle positioning in Outcome Evaluation The results of the questionnaire were
the center of the disk impossible with a To determine the effectiveness of the pro- used to calculate the Oswestry Disability
paravertebral approach and conventional cedures, a 6-month follow-up was per- Index, which was applied to assess clinical
spinal needles. CT guidance always pre- formed. We administered the Oswestry outcome. The response to treatment was
considered binary; classified as successful
if the Oswestry Disability Index was no
Figure 2 greater than 20% at follow-up, and unsuc-
cessful otherwise. Ten group B patients
with unsuccessful results had second in-
traforaminal and intradiscal O2-O3 injec-
tions, and 6-month follow-up was per-
formed.
During and after the procedures, all
patients were carefully evaluated by the
neuroradiologist who performed the
procedure in order to recognize any
complications. During phone consulta-
tion, patients were asked to report any
possible late complication. Considered
complications were allergic reactions,
high or low blood pressure induced by
drugs, infections, and permanent neu-
rologic deficits.

Statistical Analysis
An evaluation of the success rate was
performed for both groups on the basis
of the Oswestry Disability Index. The
results of the Oswestry pain question-
naire were entered in a database. The
success rates at 2-week, 3-month, and
6-month follow-up for groups A and B
Figure 2: Transverse CT images of consecutive phases of O2-O3 chemodiscolysis with left interlaminar ap- were compared by means of the ␹2 test.
proach at L5-S1 level in 21-year-old man in prone position. (a) Preprocedural image shows right paracentral disk P ⬍ .01 was considered to indicate a
extrusion (arrow). (b) Tip of needle (arrow) is positioned close to the herniation; dural theca is not located along
statistically significant difference.
needle entry path. (c) Needle (arrow) is inside the disk and its position is extrathecal. After further needle entry, drugs
The success rate of group B patients
are injected. (d) Postprocedural image shows wide distribution of gas (ⴱ) inside the disk.
who underwent a second intraforaminal

910 Radiology: Volume 242: Number 3—March 2007

VASCULAR AND INTERVENTIONAL RADIOLOGY: Sciatica: Oxygen-Ozone versus Steroid Injection Gallucci et al

Figure 3
and intradiscal O2-O3 injection session of group A, and seven were part of
was calculated; however, no formal statis- group B. After 6 months, the treatment
tic was used because of the low number of was successful in two (40%) of five
patients. The success and complication group A patients and in five (71%) of
rates of the patients treated with the in- seven group B patients.
terlaminar approach were also consid-
ered separately to evaluate both the effec- Complications
tiveness and the safety of this approach. During or after the procedures, no ma-
The software used for statistical jor or minor complications were ob- Figure 3: Graph shows outcomes of group A
analysis was Stata (version 8.2; Stata- served. and group B patients whose treatment was deemed
Corp, College Station, Tex). a success according to their responses to the Os-
westry pain questionnaire. At 2 weeks and 3
Discussion months, outcome of group B patients is similar to
Results In our series, we administered an intra- that of group A patients. Difference becomes ap-
discal steroid and an anesthetic. Intra- preciable after 6-month follow-up, when the pro-
Group A discal anesthetics are useful for disco- cedure was successful in 74% of group B and in
In group A, the treatment was a success genic pain diagnosis and treatment 47% of group A patients (P ⬍ .01).
in 69 (90%) of 77 patients (95% confi- (20). Intradiscal steroid injection is not
dence interval [CI]: 80.6%, 95.4%) af- a definitively established treatment, and
ter 2 weeks, 52 (67%) patients (95% studies have shown discordant results synthesis and release of prostaglandins,
CI: 55.9%, 77.8%) after 3 months, and (25,26). Intradiscal steroids and anes- bradykinin, and various algogenic mole-
36 (47%) patients (95% CI: 35.3%, thetics can be useful mainly in patients cules (27). Moreover, ozone increases
58.5%) after 6 months. The treatment with reactive endplate changes (25). the release of antagonists of proinflam-
was unsuccessful in 41 (53%) patients Pain reduction can also depend on the matory cytokines (27). Thus, O2-O3 can
after 6 months. block of Luschka nerve fibers that enter solve or decrease chemical radiculitis
the annulus. (28,30). The effect of ozone on chemical
Group B Periganglionic and intradiscal injec- radiculitis can also explain the clinical
In group B, the treatment was a success tions of O2-O3 have been proposed since effectiveness of intraforaminal O2-O3
in 72 (88%) of 82 patients (95% CI: the late 1990s as a treatment for lumbar injection without intradiscal therapy
78.8%, 93.4%) after 2 weeks, 64 (78%) disk herniation (14–18). Ozone is an un- (19).
patients (95% CI: 67.5%, 86.4%) after stable form of oxygen that, in water, re- The reported effectiveness of the
3 months, and 61 (74%) patients (95% acts with organic molecules containing procedure is promising, with clinical
CI: 63.6%, 83.3%) after 6 months. At double or triple bonds: Ozone causes an success in 70%– 80% of patients (14–
6-month follow-up, the treatment was oxide reduction called ozonolysis. This re- 18). In our practice, we inject a steroid
unsuccessful in the remaining 21 (26%) action involves mainly molecules for and a local anesthetic in addition to the
group B patients. Among the 10 group B which ozone has affinity (27). Intradiscal O2-O3 mixture, because the combina-
patients who underwent a second O2-O3 O2-O3 mixture injection produces a che- tion of these agents has been proved to
procedure, the 6-month follow-up re- modiscolysis, with ozonolysis of nucleus be more effective than the injection of
vealed a satisfactory outcome in five pulposus proteoglycans, loss of water, the O2-O3 mixture alone (15).
(50%) patients. and dehydration. Progressive degenera- Group B had a successful outcome
tion with fibrous replacement occurs fol- in 74% of patients after 6 months,
Groups A and B Comparison lowed, finally, by disk shrinkage. In this while group A had a successful out-
The statistical analysis with ␹2 test way, chemodiscolysis leads to loss of disk come in 47% of patients. The statisti-
showed that the different outcome at 2 volume and direct reduction of root com- cal analysis demonstrated that this dif-
weeks was not significant (␹2 ⫽ 0.13, pression. Chemodiscolysis has been ference was significant (P ⬍ .01); con-
P ⫽ .72). After 3 months, the difference shown experimentally in rabbit and hu- sequently, the combined injection of
was also not significant (␹2 ⫽ 2.23, P ⫽ man disks, with histopathologic evidence O2-O3, a steroid, and an anesthetic at
.136). On the contrary, the ␹2 test of dehydration of the fibrillary matrix of the intradiscal and intraforaminal lev-
showed that after 6 months, the suc- the nucleus pulposus, vacuole formation, els should be considered more effec-
cess rate difference between group A and collagen fragmentation (15,28,29). tive than a simple steroid and anes-
and group B was statistically significant The reduction of herniated disk volume thetic injection. The injection of O2-O3
(␹2 ⫽ 12.75, P ⬍ .001) (Fig 3). decreases root edema and venous stasis, is the only difference between the two
stopping the demyelination process (28). treatments we compared; therefore,
Interlaminar Approach The mixture also has analgesic and the better outcome of group B patients
Five of the 12 patients treated by means antiinflammatory effects. Ozone, by should be due to the pharmacologic
of an interlaminar approach were part means of direct ozonolysis, inhibits the actions of O2-O3. Our results are simi-

Radiology: Volume 242: Number 3—March 2007 911

VASCULAR AND INTERVENTIONAL RADIOLOGY: Sciatica: Oxygen-Ozone versus Steroid Injection Gallucci et al

lar to those reported in other studies Future studies are necessary to demon- flitto disco-radicolare. Riv Neuroradiol 1997;
(14–18) in which intradiscal O2-O3 in- strate whether O2-O3 therapy effects 10:545–550.
jections were not compared with are limited over time. 10. Osborn AG. Nonneoplastic disorders of the
other percutaneous interventional In conclusion, intraforaminal and in- spine and spinal cord. In: Diagnostic neuro-
treatments. Small differences between tradiscal injections of an O2-O3 mixture, radiology. St Louis, Mo: Mosby, 1994; 820 –
our and other studies may be related a steroid, and an anesthetic with CT 875.
to patient selection and evaluation guidance lead to rapid pain relief, with 11. Choy DS, Ascher PW, Ranu HS, et al. Percu-
methods. good outcome in most patients. This taneous laser disc decompression: a new
We observed that 2 weeks and 3 treatment is easy to perform and is safe. therapeutic modality. Spine 1992;17:949 –
months after the procedure, the differ- Moreover, it is more effective than the 956. [Published correction appears in Spine
1993;18:939.]
ence in success rate between group A injections of pure steroids and anes-
and group B was not significant. The thetic in the same sites; therefore, 12. Onik G, Helms CA, Ginsburg L, Hoaglund
difference became significant only after O2-O3 seems to play a role in pain relief. FT, Morris J. Percutaneous lumbar diskec-
6 months, probably because the effec- In our opinion, O2-O3 chemodiscolysis tomy using a new aspiration probe. AJR
Am J Roentgenol 1985;144:1137–1140.
tiveness of steroids and anesthetics ad- should be regarded as a useful treat-
ministered to both groups is temporary, ment for the management of lumbar 13. Wittenberg RH, Oppel S, Rubenthaler FA,
while O2-O3 has long-acting effects. disk herniation. Steffen R. Five-year results from chemo-
nucleolysis with chymopapain or collagenase:
Therefore, in comparison to conven- Acknowledgment: The authors thank Dr An- a prospective randomized study. Spine 2001;
tional steroid injections, O2-O3 therapy gela Martella for translation of the manuscript. 26:1835–1841.
appears to be a more effective treat-
ment. 14. D’Erme M, Scarchilli A, Artale AM, Pasquali
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