Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation on Functioning in Patients Affected by Nec
Phase: PHASE1
Conditions: Cervical Pain, Posterior
Sponsor: University of Catanzaro

Study Protocol 
Official Title: 
Efficacy of oxygen-ozone therapy and cervical rehabilitation on functioning in patients affected by 
neck pain: a prospective double-arm study 
NCT Number: NCT pending 
Document Date: March 20th 2026 
 
1. Background and Rationale 
Neck pain is a highly prevalent musculoskeletal condition associated with disability and reduced 
quality of life. Oxygen-ozone (O₂O₃) therapy has shown potential benefits in reducing pain and 
inflammation. However, evidence on its combined use with structured rehabilitation programs is 
limited. This study aims to evaluate the effectiveness of O₂O₃ therapy followed by cervical 
rehabilitation. 
2. Study Objective 
To evaluate the effectiveness of O₂O₃ therapy combined with cervical rehabilitation, and to compare 
McKenzie-based therapy with Back School exercises in improving pain, disability, and quality of 
life in patients with neck pain. 
3. Study Design 
Prospective, two-arm study with participants randomly allocated (1:1) to two rehabilitation groups 
following O₂O₃ therapy. 
4. Participants 
Adults (≥18 years) with chronic neck pain (≥12 weeks) and pain intensity ≥4 on NRS. 
5. Intervention 
All participants receive 8 weekly intramuscular paravertebral O₂O₃ injections (10 μg/mL, 10 mL 
total). 
After injections: 
• 
Experimental group: McKenzie rehabilitation (10 sessions, 2 weeks) 
• 
Control group: Back School program (10 sessions, 2 weeks) 
6. Outcome Measures 
• 
Primary: Neck Disability Index (NDI) 
• 
Secondary: NRS, EQ-5D-3L, EQ-VAS 
Assessments at baseline, post-injection, post-rehabilitation, and 24-week follow-up. 
7. Statistical Analysis 
Data will be analyzed using repeated measures ANOVA and t-tests. A p-value <0.05 will be 
considered statistically significant.