Original Research


https://doi.org/10.5005/jp-journals-10066-0095
Indian Journal of Physical Medicine and Rehabilitation
Volume 31 | Issue 4 | Year 2020

Effectiveness of Ozone Diskectomy in MRI Staging 1–2 and 3–4 of Prolapse Intervertebral Disk in Terms of Pain and Functional Improvement: A Comparative Study


Amit K Mallik 1 , Deepak Kumar 2 , Sanjay K Pandey 3 , Sanyal Kumar 4 , Deependra K Rai 5 , Shikha 6

1–4,6Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Patna, Bihar, India
5Department of Pulmonary Medicine, All India Institute of Medical Sciences, Patna, Bihar, India

Corresponding Author: Sanjay K Pandey, Department of Physical Medicine and Rehabilitation, All India Institute of Medical Sciences, Patna, Bihar, India, Phone: +91 8102922824, e-mail: drsanjaykr1@gmail.com

How to cite this article Mallik AK, Kumar D, Pandey SK, et al. Effectiveness of Ozone Diskectomy in MRI Staging 1–2 and 3–4 of Prolapse Intervertebral Disk in Terms of Pain and Functional Improvement: A Comparative Study. Indian J Phys Med Rehab 2020;31(4):86–89.

Source of support: Nil

Conflict of interest: None

ABSTRACT

Aim and objective: The study aimed to see the efficacy of ozone diskectomy as a minimally invasive treatment option for MRI staging 1–2 and 3–4 in prolapse intervertebral disk (PIVD) in improving physical function and reducing pain.

Materials and methods: Setting: PMR Department, AIIMS, Patna. Study design: Prospective comparative study. Study period: One year from December 2017 to November 2018. Study population: Patients of low back pain attending PMR OPD with the diagnosis of PIVD at L4–L5, L5–S1, and fulfilling the inclusion criteria. Outcome measures: Improvement in pain and function by using a visual analog scale (VAS) and Oswestry disability index (ODI), respectively.

Results: Functional status of group I (MRI stages 1–2) was significantly improved on Oswestry low back pain disability score and pain intensity on VAS score with a p value %3C; 0.0001.

Conclusion: Ozone diskectomy is a more effective treatment option for PIVD with MRI stages 1–2 in comparison to stages 3–4.

Keywords: Lumbar diskectomy, Pain, Prolapse intervertebral disk, Visual analog scale.

INTRODUCTION

Low back pain is an important health problem in whole the world. Point prevalence ranges from 12 to 33%, 1-year prevalence is between 22 and 65%, and lifetime prevalence varies from 1 to 84%. 1 Herniated disk or nucleus pulposus is one of the commonest causes of low back pain, Mixter and Barr stated that in 1934. 2

About 90% of low back pain patients respond to medical treatment including analgesics and physiotherapy. Decompression nerve root either by surgery or some percutaneous intradiskal procedure is required in only 10% of cases. In 1963, the first intradiskal therapy, done in humans by chemonucleolysis using chymopapain. 3

Breakthrough of nucleus pulposus via annulus-fibrosus (tire-like structure) is called as herniation of the nucleus pulposus (HNP) of an intervertebral disk (Fig. 1). The detrimental effect of weight transfer in the spine occurs at the anatomical junction where the curvature of the spine changes like cervicothoracic (C8–T1), thoracolumbar (T12–L1), and lumbosacral, maximally at lumbosacral. After the age of 30 years, the anatomical and biochemical properties like water content and elasticity inside the nucleus pulposus reduces progressively with time.

The progression of symptoms in HNP varies from slow to sudden onset. Four stages (Fig. 2) are as follows: (1) disk protrusion, (2) prolapsed disk, (3) disk extrusion, and (4) sequestered disk. Stages 1 and 2 are incomplete, whereas 3 and 4 are referred to as complete herniations. Pain may be a combined effect of disk herniation and radiculopathy associated with sensory-motor changes (tingling, numbness, weakness, loss of reflex). 4

Ozone is an allotrope of O2 and it is much less stable than di-atomic allotrope (O2). The gas is colorless to pale-blue with a distinctively, acrid/pungent smell. The clinical use of ozone for therapeutic purposes is increasing nowadays at many centers especially in pain management. Newer modifications in techniques and administration of ozone, more and more publication of scientific materials in the medical journals and animal studies are making it more acceptable to the medical community and gradually it is becoming more popular. 5

In 1998, Muto and Avella started the administration of intradiskal ozone injection for disk herniation under CT guidance. After the breakdown of the ozone molecule, it releases active oxygen. Due to the reaction, proteoglycans in the nucleus pulposus lose the capacity to hold water, and this results in desiccation of the disk leading to decompression of nerve roots. 5 After ozone diskectomy, the successful outcome has been reported by many European centers. 68

For pain management in prolapse disks, ozone is now used in many centers throughout the country. But it is still not very clear that in which grade of herniation it will be more useful. To our knowledge, limited studies had been undertaken. So we have done this study to see the efficacy of ozone diskectomy in prolapse intervertebral disk (PIVD) MRI stages of 1–2 and 3–4 for improvement in pain and function.

Fig. 1: Herniation of the nucleus pulposus

MATERIALS AND METHODS

This prospective comparative study was carried out from December 2017 to November 2018 at AIIMS, Patna. Seventy-two adult patients with low back pain due to intervertebral disk prolapse in the lumbar region were included over a period of 1 year. We lost six patients in follow-up due to dropout.

Selection Criteria

After failure to conservative therapy for 4 weeks and refusal of surgical intervention, all patients were chosen. All the patients with low back pain who attended our OPD during the recruitment period from December 2017 to November 2018 were included in this study. Follow-ups were done at 3 weeks, 3 months, and 6 months.

Patients with the following inclusion criteria 9 were selected in this study:

  • VAS score ≥6.
  • Pain with radiculopathy for %3E;4 weeks duration.
  • PIVD at lumbar region diagnosed with MRI imaging.
  • SLR = positive (30–70°).
  • Patients with positive femoral nerve stretch test.
  • Functional impairment.

Exclusion Criteria 9

  • Presence of red flag.
  • History of bleeding disorder.
  • Infection at the site.
  • Glucose 6PD deficiency.
  • Poor diabetes.
  • Spinal tuberculosis.
  • Hyperparathyroidism.
  • Pregnancy.
  • Non-willing patients.

Fig. 2: Four stages of herniation of the nucleus pulposus

Outcome Measures

  • For pain–visual analog scale (VAS) scores range from 0 to 10 (higher scores indicate greater pain intensity).
  • For functional impairment—Oswestry disability index (ODI) was used. Each of the 10 questions is scored from 0 to 5, giving a maximum score of 50. The total score is then converted into a percentage by multiplying it by 2. Scores are stratified into severity: 0–20, minimal disability; 21–40, moderate disability; 41–60, severe disability; 61–80, crippling back pain; 81–100, limited to bed. For the results to be deemed clinically significant, a change in the patient’s score of 10% or more is required. 10

Procedure

Informed consent was obtained from all the patients. During the procedure, patients were kept in a prone position with a pillow placed under the abdomen. Under C-arm guidance, the procedure was performed. The vertebral level was determined with C-arm by focusing on an anteroposterior view. To abolish any double endplates and getting the widest possible view of the disk space (squaring) C-arm was angled cranially or caudally. To get the facet joint at the center of the endplates, C-arm was obliquely rotated. In corresponds to the center of the disk needle was inserted just lateral to the superior articular process. After identification of the needle puncture site, the skin was marked. After antiseptic dressing and draping, the marked site was infiltrated with 2% lignocaine. Then, a 20 gauge 12 cm long needle was inserted into the affected disk using the tunnel view under fluoroscopic guidance. The position of the needle was confirmed by the lateral view of the spine and 4 to 8 mL of the oxygen–ozone mixture at a concentration of 27–30 μg/mL was injected into the disk by ozone resistant syringe over a period of 15–20 seconds similar to study done by Viebahn in 1994, in which nontoxic concentration of ozone varies from 1 to 40 μg/mL of oxygen. 11 Because higher concentration (>40 μg/mL) of ozone may cause membrane degradation due to the superoxide anion and hydrogen peroxide accumulation. 1113 After the procedure, patients were kept in the supine position for a minimum of 2 hours, then they were discharged after supervised monitoring for 48 hours with advice to gradually resume their activities of daily living. Regular follow-up was done at 3 weeks, 3 months, and 6 months. Assessment of pain was done on VAS and functional impairment by Oswestry disability index (ODI).

Statistical analysis was performed by SPSS 21 software. The Student’s t-test was used for descriptive statistics like means. At a confidence interval of 95%, the level of significance was accepted when p is %3C;0.05.

RESULTS

Sixty-six patients of both genders between 25 and 65 (average 46.04) years were included in the study (Table 1). They were assessed for pain and functional improvement on VAS and ODI, respectively. The intensity of pain was significantly reduced following ozone diskectomy in group I (MRI stages: 1–2 HNP) on VAS score from 7.61 ± 0.79 (1st visit) to 5.33 ± 1.73 (at 3 weeks) and at the end (at 6 months) 2.09 ± 0.68 with p value <0.0001 which was statistically significant (Table 2). The functional status of patients in group I was also significantly improved on Oswestry low back pain disability score from 85.52 ± 4.34 (0 weeks) to 55.15 ± 21.90 (3rd week) and 16.24 ± 7.64 (at 6 months) with p value <0.0001 was also statistically significant (Table 3). No significant adverse reactions were reported throughout the study except minor pain at the site of intervention which subsided after giving paracetamol.

Table 1: Baseline characteristics of group I (stage 1–2 HNP) and group II (stage 3–4 HNP)
Variables Group
p value
Age (years) 1 2
  <30 2 (6.1) 2 (6.1) 0.706
  30–40 9 (27.3) 11 (33.3)
  41–50 12 (36.4) 11 (33.3)
  51–60 10 (30.3) 9 (27.3)
Sex
    Female 26 (78.8) 21 (63.6) 0.174
    Male 7 (21.2) 12 (36.4)
BMI (kg/m2) Cases Controls 0.462
  <18.5 0 (0) 0 (0)
  18.5–25 4 (12.1) 9 (27.3)
  25–30 28 (84.8) 22 (66.7)
  %3E;30 1 (3) 2 (6.1)
PIVD
    L4–5 26 (78.8) 28 (84.8) 0.541
    L4–5, L5–S1 1 (3) 0 (0)
    L5–S1 6 (18.2) 5 (15.2)
VAS score 0.152
7.61 ± 0.79 7.88 ± 0.74
ODI score 0.683
85.52 ± 4.34 85.94 ± 4.05
Table 2: VAS score—a comparison in group I (stage 1–2 HNP) and group II (stage 3–4 HNP)
Duration Group I Group II Total p value
0 7.61 ± 0.79 7.88 ± 0.74 7.74 ± 0.77 0.152
3 weeks 5.33 ± 1.73 7.64 ± 0.60 6.48 ± 1.73 <0.001*
3 months 2.91 ± 0.80 6.70 ± 1.29 4.80 ± 2.19 <0.001*
6 months 2.09 ± 0.68 6.73 ± 1.31 4.41 ± 2.55 <0.001*

* In between group I and II in all follow ups, signifies that ozone diskectomy better works on group I in comparison to group II

Table 3: ODI score—a comparison in group I (stage 1–2 HNP) and group II (stage 3–4 HNP)
Duration Group I Group II Total p value
0 85.52 ± 4.34 85.94 ± 4.05 85.73 ± 4.17 0.683
3 weeks 55.15 ± 21.90 80.55 ± 8.27 67.85 ± 20.82 <0.001*
3 months 24.18 ± 8.50 68.88 ± 14.59 46.53 ± 25.45 <0.001*
6 months 16.24 ± 7.64 75.79 ± 10.82 46.02 ± 31.41 <0.001*

* In between group I and II in all follow ups, signifies that ozone diskectomy better works on group I in comparison to group II

DISCUSSION

A similar finding was also reported in the study done by Muto and Avella 5 in 1998 on 2,200 patients. Disk degeneration leads to decreased efficacy (40% excellent and 39% fair). From our study also it is proved that the effectiveness of ozone diskectomy reduces with the advancement of prolapse.

The disappearance of a herniated disk was noted with progressive shrinkage due to breakdown and degeneration of matrix as a result of reactive oxygen species (ROS) action on the proteoglycans of nucleus pulposus shown by a study done by Bocci et al. 14

There was a study that shown excellent results after 6 months by Bonetti et al. 7 Explanation of this procedure was that it improves the microcirculation and supply of oxygen by reducing venous stasis and attenuation of nerve root compression. The mechanism behind the analgesic and anti-inflammatory action of ozone is by inhibiting the synthesis of prostaglandin and, subsequent release of inflammatory cytokines. Iliakis et al. 15 proved that ozone also increases the release of antagonists to proinflammatory cytokines.

According to Ghatge et al., 16 ozone diskectomy is a relatively low cost and very effective choice for the treatment of prolapse disk. It is also a minimally invasive procedure. In comparison to surgery, it takes less time to perform. So it is a minimally invasive, time, and cost-effective technique. It can be considered as the treatment of choice in earlier stages of disk prolapse. The same was proved by this study also.

CONCLUSION

Ozone diskectomy is an effective treatment option for pain relief and functional improvement. It is more effective in the HNP of MRI stages 1–2 in comparison to stages 3–4.

LIMITATIONS OF STUDY

The limitations of the study are lack of control, blinding, and short duration of follow-up.

REFERENCES

1. Walker BF. The prevalence of low back pain: a systemic review of the literature from 1966 to 1998. J Spinal Disord 2000;13(3):205–217. DOI: 10.1097/00002517-200006000-00003.

2. Mixter WJ, Barr JS. Rupture of the intervertebral disc with involvement of the spinal canal. N Eng J Med 1934;211(5):210–215. DOI: 10.1056/NEJM193408022110506.

3. Smith LW. Enzyme dissolution of the nucleus pulposus in humans. JAMA 1964;187(2):137–140. DOI: 10.1001/jama.1964.03060150061016.

4. Dawson EG. Herniated Discs: Definition, Progression, and Diagnosis. [online] SpineUniverse. Available at: https://www.spineuniverse.com/conditions/herniated-disc/herniated-discs-definition-progression-diagnosis [ Accessed 3 January 2021].

5. Muto M, Avella F. Percutaneous treatment of herniated lumber disc by intradiscal oxygen-ozone injection. Int Neuroradiol 1998;4(4):279–286. DOI: 10.1177/159101999800400403.

6. Muto M, Andreula C, Leonardi M. Treatment of herniated lumber disc by intradiscal or intraforaminal oxygen-ozone (O2-O3) injection. J Neuroradiol 2004;31(3):183–189. DOI: 10.1016/s0150-9861(04)96989-1.

7. Bonetti M, Fontana A, Cotticelli B, et al. Intraforaminal O2-O3 versus periradicular steroidal infiltrations in low back pain. Randomized controlled study. Am J Neuroradiol 2005;26(5):996–1000.

8. Andreula CF, Simonetti L, De Santis F, et al. Minimally invasive oxygen-ozone therapy for lumber disc herniation. Am J Neuroradiol 2003;24(5):996–1000.

9. Das G, Ray S, Ishwarari S, et al. Ozone nucleolysis for management of pain and disability in prolapsed lumber intervertebral disc A prospective cohort study. Interv Neurorad 2009;15(3):330–334. DOI: 10.1177/159101990901500311.

10. Fairbank JC, Couper J, Davies JB, et al. The oswestry low back pain disability questionnaire. Physiotherapy 1980;66(8):271–273.

11. Viebahn R. The use of ozone in medicine. In: ed. R, Viebahn eds. Classical medical ozone textbook. 2nd ed. Heidelberg: Karl F Haug Publishers; 1994. pp. 1–178.

12. Bellomo C, Mirabelli F. Glutathione-mediated mechanism of defence against free radical-induced hepatotoxicity. Hum Toxicol 1989;8(2):152. DOI: 10.1177/096032718900800221.

13. Bellomo C, Mirabelli F, Richelmis P, et al. Oxidative stress-induced plasma membrane blebbing and cytoskeletal alterations in normal and cancer cells. Ann NY Acad Sci 1989;551 (1 Membrane in C):128–130. DOI: 10.1111/j.1749-6632.1988.tb22327.x.

14. Bocci V, Borrelli E, Zanardi I, et al. The usefulness of ozone treatment in spinal pain. Drug Des Devel Ther 2015;9:2677–2685. DOI: 10.2147/DDDT.S74518.

15. Iliakis E, Valadakis V, Vynios DH, et al. Rationalization of the activity of medical ozone on intervertebral disc: a histological and biochemical study. Rivista di Neuroradiologia 2001 (suppl 1):23–30. DOI: 10.1177/19714009010140S105.

16. Ghatge S, Modi PD, Modi DB. Clinical and radiological improvement following ozone disc nucleolysis: a case report. Cureus 2017;9(4):e1162. DOI: 10.7759/cureus.1162.

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