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

Abstract

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 μg/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 (ΔT0-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.