Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation

NCT07504432 | Completed Phase 1

• 1 other identifier: 78/2024
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cervical Pain, Posterior

Keywords

ozone therapy; cervical pain; physiotherapy

Outcome Measures

Primary Outcomes (1)

• Neck Disability Index (NDI)

  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.

  From enrollment to the end of treatment at 24 weeks

Study Arms (2)

Study group

EXPERIMENTAL

Intramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles. Following the injection cycle, patients underwent a structured rehabilitation program based on the McKenzie method.

Drug: Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program

Control group

ACTIVE COMPARATOR

Intramuscular paravertebral O₂O₃ therapy was administered by a physician specialized in Physical and Rehabilitation Medicine with expertise in ozone injections. All participants received 8 weekly cervical paravertebral injections of an O₂O₃ gas mixture (10 μg/mL, total volume 10 mL), delivered using a 27-gauge needle. Each session consisted of five symmetrical injections of 2 mL into the paravertebral cervical muscles. Following the injection cycle, patients underwent a structured rehabilitation program based on the Back School method.

Drug: Combined O₂O₃ Injection and back school Rehabilitation Program

Interventions

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.

Study group

Combined O₂O₃ Injection and back school 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 back school, consisting of 10 supervised sessions over a 2-week period, focused on repeated cervical movements, postural correction, and patient-directed exercises.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (1)

University "Magna Graecia "of Catanzaro

Catanzaro, CZ, 88100, Italy

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 31, 2026
• Study Start: March 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 30, 2024
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

IT (1)