ANTIOXIDANT NUTRITIONAL SUPPORT AS ADJUNCT TO OXYGEN-OZONE THERAPY IN CHRONIC PAIN: A PILOT RCT OF A NURSE-NUTRITIONIST CO-MANAGEMENT PROTOCOL

G. Fedelfranco¹, N. Misceo² | ¹Social Health Local District, ASL Bari, U.O. Door of Unique Access(PUA)/Multidimensional evaluation Unit (UVM), University of Bari "Aldo Moro", Italy; ²Ministry of Health, SASN Bari, Italy

Background & Aims. Oxygen-ozone therapy (O3T) exerts analgesic and anti-inflammatory effects through reactive oxygen species (ROS) signalling and cytokine modulation. However, excessive oxidative stress — particularly in nutritionally deficient patients — may attenuate O3T efficacy and increase lipid peroxidation risk. Antioxidant nutrients (vitamins C and E, selenium, glutathione precursors, polyphenols) theoretically modulate O3T's oxidative window, potentially optimising its therapeutic margin. No study has examined nutritional antioxidant status as a predictor of O3T response, nor evaluated an antioxidant nutritional co-protocol. This study aims to: (1) characterise baseline antioxidant nutritional status (ORAC, serum vitamins C and E, selenium) in chronic pain patients undergoing O3T; (2) test whether a 4-week antioxidant supplementation protocol (ASP) potentiates O3T analgesic response (NRS); (3) describe ASP implementation through PDSA-guided nurse-nutritionist co-management.
Methods. Design: Pilot RCT (1:1, O3T+ASP vs O3T+placebo). Setting: Social Health Local District Bari + Pain Unit + community nurse and nutritionist, 2025–2026 (N=60; N=30 per arm). ASP components: vitamin C 1000mg/day, vitamin E 400IU/day, selenium 200µg/day, N-acetylcysteine 600mg/day, 4 weeks. Instruments: ORAC serum assay (Italian reference values, ENEA); 8-OHdG (oxidative stress marker); NRS, BPI-SF, PGIC. Process instruments: NCP module, antioxidant monitoring log in SIAP. Change management: PDSA + CFIR facilitator mapping. Statistics: ANCOVA (BPI-SF change at week 4, adjusted for baseline ORAC).
Results. (Prelim.) Baseline screening (N=34): Mean serum vitamin C 28.4 µmol/L (below optimal <40 µmol/L) in 67.6%. Selenium deficiency (<70 µg/L) in 55.9%. Significant inverse correlation between baseline ORAC and BPI-SF pain intensity (r=−0.47, p=0.005). ASP 4-week interim (N=16 intervention): NRS reduction 2.4 points vs 1.3 points control (Δ=1.1, 95%CI 0.2–2.0, p=0.018). PGIC 'improved': 81.3% ASP vs 56.3% control (p=0.047).
Conclusions. Antioxidant nutritional status is significantly associated with O3T analgesic response in Italian chronic pain patients, and targeted antioxidant supplementation appears to potentiate O3T efficacy. The nurse-nutritionist ASP co-protocol, implemented via PDSA cycles and NCP documentation, provides a feasible and innovative adjunct to standard O3T, warranting a full adequately powered RCT.