BACKGROUND: Low back pain (LBP) is mostly induced by disc herniation (DH) or degeneration and has a burden upon social activity and economical aspects of life. An abundance of medical and surgical interventions have evolved to resolve this problem, but one of the newly introduced techniques, which is the minimally invasive, low cost ozone-oxygen mixture (O₃-O₂) intradiscal injection, offers a rapid onset amelioration of symptoms with a sustained duration of pain relief. OBJECTIVE: We aim to evaluate the quality of pain alleviation using 2 different doses of intradiscal injections of O₃-O₂ mixture. STUDY DESIGN: A prospectively randomized, single-blind study. SETTING:Pain clinic, anesthesia, intensive care, and pain department in Assiut University Hospitals. METHODS:Sixty patients with symptomatizing single lumbar DH were subjected to O₃-O₂ intradiscal injection and randomly allocated into one of 2 groups; group A: received 10 mL, 40 µg/mL of O₃-O₂ and group B: received 10 mL, 30 µg/mL of O₃-O₂. Pain score and functional ability of the patients using the visual analog scale (VAS) and Oswestry Disability Index (ODI) were evaluated after 1, 6, and 12 months and compared to the basal values. Patient satisfaction and reduction of DH were evaluated after the sixth month. RESULTS: There were no significant differences between the 2 groups regarding the clinical outcome; however both the ODI and VAS evaluations showed highly significant improvement (decreased) (P < 0.01) after injection and during the entire follow-up period. There were highly significant negative correlations between the DH reduction percentage and both the VAS and ODI scores after 6 months in both of the groups. LIMITATIONS: This study was limited by a small sample size; it was also an active control trial, which may explain the insignificant difference in between the groups, in addition to being a single-blind trial. CONCLUSION: Intradiscal injection of O₃-O₂ mixture is a very valuable maneuver in the reduction of DH size and improvement of pain quality, with either ozone concentrations of 40 µg/mL or 30 µg/mL. KEY WORDS: Low back pain, ozone, disc herniation.
RCT Entities:
BACKGROUND:Low back pain (LBP) is mostly induced by disc herniation (DH) or degeneration and has a burden upon social activity and economical aspects of life. An abundance of medical and surgical interventions have evolved to resolve this problem, but one of the newly introduced techniques, which is the minimally invasive, low cost ozone-oxygen mixture (O₃-O₂) intradiscal injection, offers a rapid onset amelioration of symptoms with a sustained duration of pain relief. OBJECTIVE: We aim to evaluate the quality of pain alleviation using 2 different doses of intradiscal injections of O₃-O₂ mixture. STUDY DESIGN: A prospectively randomized, single-blind study. SETTING:Pain clinic, anesthesia, intensive care, and pain department in Assiut University Hospitals. METHODS: Sixty patients with symptomatizing single lumbar DH were subjected to O₃-O₂ intradiscal injection and randomly allocated into one of 2 groups; group A: received 10 mL, 40 µg/mL of O₃-O₂ and group B: received 10 mL, 30 µg/mL of O₃-O₂. Pain score and functional ability of the patients using the visual analog scale (VAS) and Oswestry Disability Index (ODI) were evaluated after 1, 6, and 12 months and compared to the basal values. Patient satisfaction and reduction of DH were evaluated after the sixth month. RESULTS: There were no significant differences between the 2 groups regarding the clinical outcome; however both the ODI and VAS evaluations showed highly significant improvement (decreased) (P < 0.01) after injection and during the entire follow-up period. There were highly significant negative correlations between the DH reduction percentage and both the VAS and ODI scores after 6 months in both of the groups. LIMITATIONS: This study was limited by a small sample size; it was also an active control trial, which may explain the insignificant difference in between the groups, in addition to being a single-blind trial. CONCLUSION: Intradiscal injection of O₃-O₂ mixture is a very valuable maneuver in the reduction of DH size and improvement of pain quality, with either ozone concentrations of 40 µg/mL or 30 µg/mL. KEY WORDS: Low back pain, ozone, disc herniation.
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