Ozone discolysis in lumbar disc prolapse

INTRODUCTION

Treatment of symptomatic lumbar disc prolapsed is still controversial.¹ There are various modalities like analgesics, muscle relaxants, physical therapy, chiropractic manipulations and surgical interventions. None of the procedures are fully satisfactory.² Pain following surgical intervention leading to failed back syndrome is reported in more than 10% of cases.³ Hence these cases require thorough analysis before surgical intervention.⁴ Before surgical removal of disc all means of conservative therapy should be exhausted. Epidural steroids and chymopapain intradiscal injections are reported with poor results and complications.^5,6 Ozone is a newer modality known to reduce the discogenic pressure and hence reduces the radiculitis.⁷ Hence we conducted a study on the efficacy of ozone discolysis in the cases of discogenic low back pain without neurological deficit.

METHODS

This was a prospective non randomized study on 75 patients in a tertiary care teaching hospital from May 2013 to April 2015. The patients of 30 to 60 years reporting to orthopaedic OPD with low back pain with or without radicular symptoms not responding to conservative treatment for at least 3 months were included in the study.

Exclusion criteria were chronic radicular pain, calcified or migrated herniated disc, neurological deficit due to disc prolapsed, previous lumbar spine surgery, other spinal pathology. Patients on oral anticoagulants were excluded from the present study. Informed consent regarding the effectiveness of Ozone usage in low back pain and chances of failure was discussed with the patients.

Thorough history was taken and clinical examination was done in all patients. Pain status was recorded as per visual pain analogue. Any motor or sensory deficit was recorded as per medical research council. All the patients were subjected for X- ray of lumbosacral spine as the duration of pain was more than 3 months. MRI was suggested in all cases to determine the exact level of disc bulge or prolapse.

Under sterile OT conditions the patients were positioned prone on the operating table. Under C arm guidance proper level was defined and Ozone injection was given by trained anesthetists. Levels injected were L3-L4 (17), L4-L5 (28) and L5-S1 (22). The post injection patients were kept in post op room for observation. Then the patients were taught for back extension exercises and postural training was given. The patients were discharged on the same day. Tools: visual pain analogue, modified Macnab scores (Table 1) and Oswestry disability index (ODI) were used to assess the outcome of the procedure (Table 2).⁹ The scoring was done by single author to prevent inter observer variation. The follow up was done at 2, 6 weeks and 6 months.

Statistical analysis

The pre injection and post injection scores were analyzed by paired t test using SPSS 10.0 version. The value was significant when p <0.05.

RESULTS

Sixty seven patients (39 males and 28 females) were observed for an average duration of 7.8 months (3 months to 14 months). The mean age of patients was 47.73 years (30-61 years). The mean duration of symptoms was 10.8 months (3months to 7 years). The commonest complaint was low back pain (83%) other was radicular pain (15%) and stenotic features (2%). On examination, SLR was positive in 8 patients (5.36%). X ray of LS spine was done in all cases. The X-ray showed degenerative changes (8 cases), L5 sacralization (2 cases), L5 wedging (2 cases), L4-L5 spondylosis (4 cases), spina bifida occulta (2 cases) and normal in 49 cases. MRI was done in all cases showed disc bulge at various level in 61 cases (91%) and prolapsed disc in 38 cases (56.71%). The level of disc bulge and prolapsed is shown in Table 3. Multiple level disc bulges was seen in 14 cases (20.89%).

Seventy five patients were selected for study. Seven patients were excluded since they did not give consent for injection. Sixty seven patients were given single intradiscal ozone injection. In case of multilevel disc bulge or prolapse only the symptomatic level was injected.

There was significant improvement in pain and ODI at the end of 2 weeks and 6 months. In 7 patients (10.44%) the pain relapsed due to disc prolapsed at same level in 3 patients (4.47%) and at different level 4 patients (5.97%). These patients were subjected rest and discectomy.

Analyzing the ODI at 2 weeks 38% patients improved. The change was significant compared to pre injection status at 2 weeks (p value 0.0154) and at 6 weeks (p value 0.0112). The improvement was not significant at 6 months compared to 6 weeks (0.8305).

DISCUSSION

The treatment of low back pain (LBP) is controversial. Multiple treatments are being advised to the patient with variable results.² Rest is usually sufficient for cases having mild pain with occasional use of analgesics. Deyo et al found two days of bed rest as adequate duration on long term follow up.¹⁰ Analgesics has no role in LBP except having short duration of pain relief with high chances of abuse potential. There are other modes of treatment like transcutaneous electrical nerve stimulation (TENS), ultrasound therapy, short wave diathermy and spinal manipulation. The scientific efficacy of these modalities is not proved.¹ Discectomy is indicated in cases with large disc prolapsed not responding to conservative treatment, acute neurological deficit and in cases with worsening neurological deficit. After discectomy persistent low back pain was found to be inversely proportional to the degree of disc prolapsed.¹¹ Failed back syndrome is a known complication with incidence up to 10%.³ The etiology of failed back surgery can be poor patient selection, incorrect diagnosis, poor surgical technique and/or recurrent pathology.^4,12 Recurrent disc herniation is reported in 3 - 7% cases.³ Hence before operating a patient with low back pain all means of conservative treatment should be tried to prevent failed back syndrome.

Intradiscal chymopapain injection and epidural steroid injections are conservative means of treatment for PIVD. Chymopapain use is obsolete due to multiple complications.^13,14 Percutaneous injections of epidural steroid are a documented procedure for sciatic symptoms without neurological deficit. The risks involved are allergic reactions, epidural abscess. Epidural hematoma, dural puncture and vasovagal reactions are reported in individual cases. Due to longer stay of the methyl prednisolone the inflammatory response is controlled. It has no role in reduction of discal pressure and disc size. Hence the chances of recurrence of pain are Medical ozone is being used in lumbar disc prolapse in Europe since 1996.⁶ On intradiscal injection of ozone free oxygen radicals are released which leads to degeneration of matrix and the disc is replace by fibrous tissue. The effective disc volume is reduced and the pressure over the nerve root is reduced. Simultaneously due to its analgesic and anti-inflammatory activity the discogenic pain is reduced.⁷ In a randomized controded trial, Gallucci et al. showed that-intraforaminal and intradiscal injections of a steroid, anesthetic and ozone are more effective at six months than injection of only a steroid and anaesthetic at the same sites.¹⁷ Moto et al. showed that between 1996 and 2003 of 2200 patients with low back pain or sciatica due to LDP. CT guided intradiscal oxygen ozone injection achieved an 80% success in 1750 patients at 6 months follow up. Success rate dropped to 75% in 1400 patients followed up to 18 months. Reduction in size of herniated disc was seen in 63% of followed up patients. Failure was mostly due to calcific herniated disc, spinal canal stenosis, recurrent disc herniation and multilevel degeneretrative disease.

In our study on 67 patients we found that 88 percent of patient had good relief at 6 weeks. The pain level decreased and the functional capacity increased gradually. There was not much improvement between 6 weeks and 6 months. The initial pain relief may be due to analgesic anti inflamatory effect of ozone since analgesic was not prescribed routinely. Postural training and back exersises helped in maintaining the good functional capacity. Relapse in seven patients was due separate disc prolapse. After initial rest they underwent disectomy.

CONCLUSION

Ozone discolysis is better modality of treatment for low back pain with disc bulge and early disc prolapse. It helps in early rehabilitation and maintenance of vertebral mechanics by retaining the disc.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the institutional ethics committee

REFERENCES

1. 1. Maher CG. Effective physical treatment for chronic low back pain. Orthop Clin North Am. 2004;35(1):57-64.
2. 2. Boswell MV, Trescot AM, Datta S, Schultz DM, Hansen HC, Abdi S, et al. Interventional techniques; evidence based practice guidelines in the management of chronic spinal pain. Pain Physician. 2007;10(1):7-111.
3. 3. Gardockl RJ, Park AL. Campbell's Operative Orthopaedics. 12th edition. Low back pain. Elsevier; 2013: 1909 -1911.
4. 4. Schofferman J, Reynolds J, Herzog R, Covington E, Dreyfuss P, O'Neill C. Failed Back surgery: Etiology and diagnostic evaluation. Spine J. 2003;3(5):400-3.
5. 5. McCulloch JA. Chemonucleolysis. J Bone Joint Surg Br. 1977;598(1):45-52.
6. 6. Buttermann GR. Treatment of Lumbar Disc Herniation: Epidural Steroid Injection Compared with Discectomy Prospective, Randomized Study. Bone Joint Surg Am. 2004;86(4):670-9.
7. 7. Andreula CF, Simonetti L, De Santis F, Agati R, Ricci R, Leonardi M. Minimally Invasive Oxygen - Ozone therapy for Lumbar Disk Herniation. Am J Neuroradiol. 2003;24(5):996-1000.
8. 8. Macnab I. Negative disc exploration; an analysis of the cause of nerve rout involvement in sixty eight patients. Bone Joint Surg Am. 1971;53:891-903.
9. 9. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry Low Back Pain Questionnaire. Physiotherapy. 1980;66:271-3.
10. 10. Deyo RA, Diehl AK, Rosenthal M. How many days of bed rest for acute low back pain: a randomized clinical trial. N Engl J Med. 1986;315:1064.
11. 11. Spangfort EV. The lumbar disc herniation. A computer aided analysis of 2504 operations. Acta Orthop Scand Suppl. 1972;142:1-95.
12. 12. Guyer RD, Patterson M, Ohnmeiss DD. Failed back surgery syndrome: diagnostic evaluation. J Am Acad Orthop Surg. 2006;14(9):534-43.
13. 13. Tregonning GD, Transfeldt EE, McCulloch JA, Ma cna b Ian, Nachemson Alf. Chymopapain versus conventional surgery for lumbar disc herniation. 10 yr results of treatment. J Bone Joint Surg. 1991;73(3):481-6.
14. 14. Poynton AR, O'Farrell DA, Mulcahy D, Corrigan NT, McManus F. Chymopapain chemonucleolysis: a review of 105 cases. J R Coll Surg Edinb. 1998;43(6):407-9.
15. 15. Runu R, Sinha NK, Pai R, Shankar PR, Vijayabhaskar P. Our experience with epidural steroid injections in low back pain and sciatica. Kathmandu Univ Med J (KUMJ). 2005;3(4):349-54.
16. 16. Muto M, Andreula C, Leonardi M. Treatment of herniated Lumbar disc by intradiscal and intraforaminal oxygen-ozone injection. J Neuroradiol. 2004;31(3):183-9.
17. 17. Gallucci M, Limbucci N, Zugaro L, Barile A, Stavroulis E, Ricci A, et al. Sciatica: treatment with intradiscal and intraforaminal injections of steroid and oxygen-ozone versus steroid only. Radiology. 2007;242(3):907-13.