Pain Relief, Disability, and Hospital Costs After Intradiscal Ozone Treatment or Microdiscectomy for Lumbar Disc Herniation: A 24-Month Real-World Prospective Study

Abstract

Background/Objectives: Surgery is the treatment of choice for symptomatic disc herniation after unsuccessful conservative management. This prospective study compared the impact on clinical and hospital outcomes of intradiscal ozone treatment vs. surgery (microdiscectomy/discectomy) in our clinical practice. Methods: Intradiscal ozone treatment was offered to 70 patients with scheduled surgery because of lumbar disc herniation. Initial treatment was surgery in 38 patients and ozone infiltration in 32 patients: lumbar and sciatic pain (Visual Analog Scale), Roland-Morris Disability Questionnaire score, days of hospital admission, and direct hospital costs were recorded during 24 months of follow-up. Results: At 12 and 24 months, lumbar pain, sciatic pain, and Roland-Morris score decreased significantly within both groups (p < 0.001). At 24 months, compared to the initial surgery, the initial intradiscal ozone treatment showed similar clinical outcomes with significantly lower requirements of surgery (100% versus 47%, p < 0.001) and lower hospital stay [median 2.5 (2-3) versus 0.5 (0-2) days, p < 0.001]. Direct hospital costs were significantly lower with initial ozone treatment at 12 months (p = 0.040). Conclusions: In our real-world prospective study, after 24 months of follow-up, initial intradiscal ozone treatment avoided surgery in more than half of patients and provided similar clinical outcomes with lower hospitalization requirements. In patients with lumbar disc herniation requiring surgery (microdiscectomy/discectomy), initial intradiscal ozone treatment could offer benefits for patients and healthcare service providers (NCT00566007).

Keywords: costs; disc herniation; discectomy or microdiscectomy; intradiscal ozone therapy; lumbar pain; radicular pain.

Figure 1

CONSORT diagram.

Figure 2

Lumbar and sciatic pains. (Left) Lumbar pain. Lumbar pain evaluated by the Visual Analog Scale (VAS) did not reveal statistically significant differences between the group initially treated by surgery and the group initially treated by intradiscal O3 infiltration (idO3T) at any time of measurement. Compared to basal values (Pre), lumbar pain was significantly lower at 12 and 24 months of follow-up in both patient groups. Box: quartiles 1 to 3. Black points: individual values. Median: double horizontal arrow. Mean: red diamond. * p = 0.005; ** p < 0.001. (Right) Sciatic pain. Sciatic pain evaluated by the Visual Analog Scale (VAS) did not reveal statistically significant differences between the group initially treated by surgery and the group initially treated by intradiscal O3 infiltration (idO3T) at any time of measurement. Compared to basal values (Pre), sciatic pain was significantly lower at 12 and 24 months of follow-up in both patient groups. Box: quartiles 1 to 3. Black points: individual values. Median: double horizontal arrow. Mean: red diamond. ** p < 0.001.

Figure 3

Roland-Morris Disability Questionnaire. The Roland-Morris Disability Questionnaire did not reveal statistically significant differences between the group initially treated by surgery and the group initially treated by intradiscal O3 infiltration (idO3T) at any time of measurement. Compared to basal values (Pre), the Roland-Morris Disability Questionnaire value was significantly lower at 12 and 24 months of follow-up in both patient groups. Box: quartiles 1 to 3. Black points: individual values. Median: double horizontal arrow. Mean: red diamond. ** p < 0.001.

Figure 4

Admission days and hospital costs. (Left) Days of hospital admission. Days of hospital admission considering all hospital treatments required for the management of LDH were significantly higher in the group of patients initially treated by surgery than in the group initially treated by intradiscal O3 infiltration (idO3T): 2 days (2–3) versus 0 days (0–2) at 12 months of follow-up, and 2.5 (2–3) versus 0.5 (0–2) at 24 months of follow-up. Box: quartiles 1 to 3. Black points: individual values. Median: double horizontal arrow. Mean: red diamond. ** p < 0.001. (Right) Direct hospital costs. Direct hospital costs considering all hospital treatment required for the management of LDH were higher in the patient group initially treated by surgery than in the group initially treated by intradiscal O3 infiltration (idO3T): 4156.13 (3605.26–4662.95) € versus 1274.40 (1274.40–5586.78) € at 12 months of follow-up (p = 0.04), and 4330.45 (3631.5–5404) € versus 2757.98 (1274.40–6540.66) € at 24 months of follow-up (p = 0.101, not statistically significant). Box: quartiles 1 to 3. Black points: individual values. Median: double horizontal arrow. Mean: red diamond.