Combined Oxygen-Ozone and Porcine Injectable Collagen Therapies Boosting Efficacy in Low Back Pain and Disability

Abstract

Background/Objectives: Intervertebral disc degeneration is the most common cause of low back pain (LBP), and lumbosciatica is a major challenge to healthcare systems worldwide. For years, ozone therapy has been used with excellent results in intervertebral disc disease and in patients with LBP. In vitro studies have demonstrated the positive action of porcine collagen in extracellular matrix remodeling and homeostasis. These tissue changes, associated with LBP, may suggest an indication for combined ozone/collagen treatment in patients with LBP. However, no studies have been reported regarding this combination of treatments. Methods: The present work compared retrospective data of two treatment groups (each of 10 LBP patients): (A) oxygen-ozone therapy (OOT) vs. (B) OOT plus porcine collagen type 1 injections (COL I). Pain intensity and physiological function were assessed by the numerical rating scale (NSR) method. The Roland-Morris questionnaire was used to assess disability. Patient data were acquired before, during, and at the six-month follow-up. Significant differences were assessed by ANOVA and Student's t-test. Results: The analyses revealed significant statistical differences comparing the two arms, where the (OOT+COL I) treatment demonstrated a booster efficacy in pain (a reduction of 62% vs. 35%), while the questionnaire revealed a reduction in disability (70% vs. 31%). Conclusions: Therefore, this combination therapy (oxygen-ozone plus porcine injectable collagen) might be a promising approach for the management of patients with LBP.

Keywords: Roland–Morris questionnaire; combination therapy; low back pain; low back pain clinical management; numerical classification scale; oxygen–ozone therapy; porcine collagen injection; porcine collagen type 1.

Figure 1

Schematic representation of the subdivision of the two groups (A and B) treated with oxygen–ozone treatment (OOT) and porcine collagen type 1 (COLI). To the left, MRI drives the physician to select the points of injections.

Figure 2

Results of NRS analyses: (A) distribution of NRS within the two cohorts of patients, prior to treatments; (B) analysis of the mean value of NRS in the follow-up period; (C) NSR delta at T1 in both groups; (D) change in NRS delta over time; and (E) NRS differences between T2 and T1. This graph extrapolation indicates the rate of improvement of the NRS in the two groups.

Figure 3

Functional improvement. Results of: (A) forward bending; (B) lateral flexion to the right (LFR); (C) disability questionnaire; and (D) lateral flexion to the left (LFR). In graphs (A,C), the decrease in their average value is statistically significant, where the differences between OOT vs. OOT+COL I are evident (p < 0.001). In addition, graph (A) shows an anti-parallel direction of the forward bending parameter. Conversely, the values reported in the analysis of the questionnaire revealed the same trend for the treatment with OOT vs. OOT+COL I, but, in the second treatment, the decrease was constant over time compared to that observed in the OOT treatment alone, while, within graphs (B,D) (lateral motion), the LFR and LFL analyses did not reveal significant differences comparing OOT vs. OOT+COL I treatments. However, the positivity trend was observed in both motions and the result in LFR reached a very close significant value (p = 0.0606). In addition, no inferiority level was observed for OOT+COL I compared to OOT treatment alone.

Figure 4

Treatment vs. analysis of pathologies. Results of: (A) forward bending; (B) lateral flexion to the right (LFR); (C) disability questionnaire; and (D) lateral flexion to the left (LFL). The results reported the differences between the mean value obtained at the T0 visit and the T2 visit (T2–T0). Negative values represent the positive effects of treatments. In graphs (A,C), the decrease in their average value is statistically significant (p < 0.001), where the differences between OOT vs. OOT+COL I are reversed as shown in Figure 4A. In addition, graph (A) shows an anti-parallel parameter of the direction of forward bends. Conversely, the values reported in the questionnaire analyses revealed a progressive positive trend for both treatments; however, in the OOT+COL I treatment, the decrease was significantly higher than that observed in the OOT treatment alone, while, within graphs (B,D) (lateral motion), the LFR and LFL analyses did not show significant differences comparing OOT vs. OOT+COL I. However, the positivity trend was observed in both movements, and the result in LFR reached a very close significant value (p = 0.0606). In addition, no inferiority level was observed for OOT+COL I compared to OOT treatments alone, considering all the parameters analyzed.