A Phase 1/2 interventional study of Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program and Combined O₂O₃ Injection and back school Rehabilitation Program in Cervical Pain, Posterior, sponsored by University of Catanzaro. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by University of Catanzaro · Phase 1/2, Interventional, and Treatment
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 46 is below the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →University of Catanzaro is the lead sponsor of 43 studies on the registry; 2 are open to participants now.
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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
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
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.
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.
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.
Time frame: From enrollment to the end of treatment at 24 weeks
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Catanzaro