Abstract
Background: Intradiscal ozone therapy, a minimally invasive technique, is used in patients that do not respond to standard conservative therapies for low back pain due to degenerative disc-induced lumbar disc herniation (LDH). Many studies on clinical efficacy lack a standardized injection method and are limited by inadequate study design.
Objective: This study aimed to determine the efficacy of periforaminal steroid injection together with intradiscal ozone therapy.
Study design: A prospective, double-blinded, randomized controlled trial.
Setting: A tertiary care center.
Methods: This study was conducted in 65 patients with low back and leg pain caused by LDH. Group 1 received intradiscal ozone therapy (n = 35) and Group 2 received intradiscal ozone therapy with periforaminal steroid injection (n = 30). Patients were evaluated for pain using the visual analogue scale (VAS), for disability using Oswestry Disability Index (ODI), and for quality of life using the short form 36 health survey administered pre-injection and at one and 6 months post-injection. All procedures were performed under sterile conditions using C-arm fluoroscopy.
Results: Significant improvements were observed in pain, disability, and quality of life in both groups post-treatment compared to pre-injection. Mean pre-injection VAS was not significantly different between the groups (VAS: 7.8 ± 1.1 for Group 1, 7.8 ± 1.2 for Group 2). VAS values at 6 months for Group 1 and Group 2 were as follows: 3.6 ± 2.4, 4.1 ± 1.6, respectively) (P < 0.001). Mean pre-injection ODI was not significantly different between the groups (ODI: 20.9 ± 9.6 for Group 1, 25.2 ± 10.3 for Group 2). ODI values at 6 months for Group 1 and Group 2 were as follows: 12.8 ± 9.2, 14.3 ± 7.2, respectively) (P < 0.001). However, there were no significant differences between the groups. Similarly, there was no significant difference between the 2 groups on any of these parameters.
Limitations: A limited number of patients and limited follow-up time.
Conclusion: This study showed that intradiscal ozone injection alone was sufficient to treat low back and leg pain caused by LDH and that periforaminal steroid injection does not provide additional benefit, which is contrary to the literature.
Keywords: Low back pain; intradiscal ozone; lumbar disc degeneration; lumbar disc herniation; steroid.
Methods
Our study was conducted between August 2018 and October 2018 with 80 patients included and went through a 6-month follow-up period. The study was completed with the data of 65 patients. Ethics commit-tee approval was obtained for the study, and patients were informed about the study in written and oral form.The prospective randomized, controlled, double-blind study included 80 patients between 18 and 75 years old that had low back/leg pain. While 9 patients didn’t come for a control examination, 6 patients were excluded from the study upon request, and the final analyses were performed on 65 patients.Inclusion criteria were as follows: Patients with a diagnosis of LDH because of degenerative disc disease with anamnesis; clinical examination; and imaging findings indicative of low back and leg pain, persis-tent pain for at least 3 months that was nonresponsive to conservative treatments, and absence of prior his-tory of spinal surgery. Furthermore, no interventional pain treatment was applied within the last 6 months, and patient needed a pain score greater than 4 on the visual analogue scale (VAS) and protrusion level discopathy at L4–5 or L5–S1 on magnetic resonance imaging.Exclusion criteria were as follows: Patients with systemic infection and uncontrolled systemic disease; hemorrhagic diathesis; history of lumbar surgery, glucose-6-phosphate dehydrogenase deficiency, preg-nancy, progressive motor deficits, and calcified disc; and those who refused to participate in the study.Patients were randomized into 2 groups. Group 1 received intradiscal ozone therapy and Group 2 received periforaminal steroid and local anesthetic treatments in addition to intradiscal ozone therapy. Randomization was performed using the closed envelope method. Patients were evaluated for pain, functionality, and quality of life pre-injection at one and 6 months post-injection. Pain was assessed by VAS, functionality by Oswestry Disability Index (ODI), and quality of life by the short form 36 health survey questionnaires. The primary outcome was pain intensity, and the secondary outcomes were disability and quality of life scores. The physicians and patients that made the evaluations were blinded to the treatment groups.
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