Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation

Neck pain represents one of the most prevalent and disabling musculoskeletal conditions worldwide, significantly affecting functional capacity, work productivity, and quality of life. Despite the availability of multiple conservative treatment strategies, there is still no clear consensus on the most effective rehabilitation approach, particularly when combining interventional and exercise-based therapies. In recent years, oxygen-ozone (O₂O₃) therapy has emerged as a promising minimally invasive treatment for musculoskeletal pain, due to its potential anti-inflammatory, analgesic, and microcirculatory effects. However, evidence regarding its integration with structured rehabilitation programs for neck pain remains limited. The purpose of this prospective double-arm study was to evaluate the effectiveness of a combined therapeutic approach based on O₂O₃ paravertebral injections followed by cervical rehabilitation exercises. Specifically, the study aimed to compare two commonly used rehabilitation strategies-McKenzie-based therapy and Back School exercises-in order to determine which approach provides greater benefits when associated with O₂O₃ treatment. The primary research question addressed whether the combination of O₂O₃ injections with McKenzie exercises leads to superior improvements in disability, compared to O₂O₃ combined with Back School. Secondary questions explored whether this combined approach is effective in reducing pain intensity and improving health-related quality of life in patients with chronic neck pain. To answer these questions, patients with clinically significant neck pain were treated with a standardized O₂O₃ injection protocol and subsequently allocated to one of the two rehabilitation programs. Outcomes related to disability, pain, and quality of life were assessed across multiple time points to evaluate both short-term and follow-up effects. Overall, this study seeks to clarify the added value of integrating interventional therapies with specific rehabilitation strategies and to identify the most effective combination for optimizing functional recovery in patients with neck pain.

NCT Number	NCT07504432
Lead Sponsor	University of Catanzaro
Conditions	Cervical Pain, Posterior
Enrollment	46 participants
Start Date	2024-03-01
Primary Completion	2024-11-01 (estimated)
Study Completion	2024-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-06