Efficacy of oxygen-ozone therapy and proprioceptive neuromuscular facilitation on pain and disability in patients affected by acute or subacute low back pain: A randomized controlled trial

Background: Low back pain (LBP) is one of the most common causes of disability worldwide. Although the etiology of LBP is varied, mechanical and inflammatory stimuli might involve the lumbar region, determining neurological symptoms and even radicular pain, often varying with posture. Objectives: This randomized controlled trial (RCT) aimed to evaluate the efficacy of Oxygen-Ozone (O2O3) injections and Proprioceptive Neuromuscular Facilitation (PNF) in pain relief and functioning in LBP, in comparison with a Control Group treated with O2O3 and Back School program. Methods: We included 86 patients randomly assigned to two groups affected by LBP, with a Numerical Rating Scale (NRS) scale >4. There were 8 dropouts, for a total of 78 patients enrolled. All the patients underwent 8 injections of O2O3, once a week, with a concentration of 20 mu g/mL, administered into the paravertebral musculature at L4-L5 and L5-S1 bilaterally. Subsequently, the experimental group underwent PNF treatment, while the control group received Back School techniques, 3 times/week for 4 weeks. Outcome measures included NRS, Oswestry Disability Index (ODI), EuroQol-5-Dimensions-3-Levels (EQ5D3L). We used: Independent t-test for between-group analysis, paired t-test for within-group analysis; ANOVA for repeated-measures analysis along the different time-points. Results: Both groups showed significant improvements in NRS, ODI after O2O3 injections (T1, p < 0.005). Physical therapy with O2O3 demonstrated improvements in all outcomes (p < 0.005), with greater efficacy in the PNF-group, particularly in NRS and ODI (Delta T0-T2, p < 0.005). Conclusion: This RCT demonstrated the efficacy of a combined treatment, based on O2O3 injections and PNF or Back-School, in improving pain, and functioning in LBP, with major findings in PNF management.