Efficacy of Oxygen-ozone Therapy and Cervical Rehabilitation on Functioning in Patients Affected by Nec
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Neck Disability Index (NDI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Study group
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.
干预措施: Combined O₂O₃ Injection and McKenzie-Based Rehabilitation Program (Drug)
Control group
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.
干预措施: Combined O₂O₃ Injection and back school Rehabilitation Program (Drug)
结局指标
主要结局
Neck Disability Index (NDI)
时间窗: 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.
次要结局
未报告次要终点
研究者
De Sire Alessandro
Associate Professor
University of Catanzaro