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.

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Key information

Conditions

Cervical Pain, Posterior Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University "Magna Graecia "of Catanzaro

Catanzaro, CZ, 88100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 years or older
Diagnosis of neck pain lasting at least 12 weeks
Moderate to severe pain (score ≥ 4 on a 0-10 pain scale)
Presence of muscle pain (trigger points) in the neck region
Willingness to stop pain medications or other treatments that could interfere with the study
Ability to understand the study and provide informed consent

Exclusion criteria

Cognitive impairment or inability to provide informed consent
Current use of anti-inflammatory drugs, opioids, or ongoing rehabilitation treatments
Neck pain caused by nerve damage, infections, tumors, or systemic diseases
History of recent neck trauma or surgery
Presence of serious medical conditions such as cancer, rheumatoid arthritis, fibromyalgia, thyroid disorders, or diabetes
Active infections
Pregnancy

Treatment and study plan

Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program

Drug

Intramuscular paravertebral oxygen-ozone (O₂O₃) therapy was administered using a gas mixture at a concentration of 10 μg/mL, with a total volume of 10 mL per session. The treatment was delivered through five bilateral paravertebral cervical injections (2 mL per site) using a 27-gauge needle. Sessions were performed once weekly for 8 consecutive weeks.

Following the injection phase, participants underwent a structured rehabilitation program based on the McKenzie method, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises.

Combined O₂O₃ Injection and back school Rehabilitation Program

Drug

Following the injection phase, participants underwent a structured rehabilitation program based on the back school, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises.

Primary outcomes

Neck Disability Index (NDI)

Time frame: From enrollment to the end of treatment at 24 weeks

The Neck Disability Index (NDI) is a validated, self-reported questionnaire used to assess disability related to neck pain. It consists of 10 items evaluating pain intensity and its impact on daily activities, including personal care, lifting, reading, work, driving, sleeping, and recreation. Each item is scored from 0 (no disability) to 5 (maximum disability), with a total score ranging from 0 to 50. The final score is typically expressed as a percentage, with higher scores indicating greater disability.

Sponsors and collaborators

Lead sponsor

University of Catanzaro

Other

Registry information

Official study title

Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation on Functioning in Patients Affected by Nec

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Mar 31, 2026
Registry last updated: Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed