跳至主要内容
临床试验/NCT07773428
NCT07773428已完成不适用

Comparative Effectiveness of Ozone Therapy Versus Pulsed Radiofrequency in Low Back Pain With Radiculopathy: a Retrospective Comparative Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
1
主要终点
pain intensity

研究概览

简要总结

Treatment selection for refractory radicular low back pain is frequently made in the absence of direct comparative evidence between competing minimally invasive options. By placing ozone therapy and PRF side by side within a single clinical service and following patients for six months, this study contributes pragmatic evidence that maps more closely onto everyday decision-making than isolated single-arm reports.

The findings carry practical implications for clinicians, patients, and health systems. For clinicians, a clearer understanding of which modality offers more sustained pain relief can inform first-line selection and patient counseling. For patients, improved durability of benefit translates directly into better quality of life, reduced reliance on systemic analgesics, and a lower likelihood of progressing to surgery. For resource-constrained health systems, evidence favoring a lower-cost, well-tolerated, outpatient procedure has clear value for service planning and cost-effectiveness.

Finally, by reporting outcomes transparently-including instances where between-group differences did not survive statistical adjustment-this study aims to add measured, reliable evidence to a literature that has at times been limited by small samples, heterogeneous protocols, and short follow-up.

详细描述

A retrospective comparative study was conducted at a single centre (Nizwa Hospital, Sultanate of Oman) including patients who received interventions between January 2025 and December 2025; data collection took place from 1 July 2026 to 30 July 2026 following approval by the Research and Ethical Review and Approval Committee (RERAC), Ministry of Health, Sultanate of Oman (reference DGHS/R&S/PROPOSAL_APPROVED/MoH/CSR/26/32322). A total of 69 patients were included, of whom 34 received ozone therapy and 35 underwent PRF treatment. Baseline demographic variables (age, body mass index, and gender distribution) were analyzed to confirm group comparability. Pain intensity and functional disability were assessed using the Visual Analog Scale (VAS) and the Oswestry Disability Index (ODI) at baseline, 1 month, 3 months, and 6 months.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Age greater than 18 years.
  • Low back and leg pain of more than six weeks' duration.
  • Failure to respond to conservative management.
  • Grade I-IV disc pathology.
  • Unilateral leg pain.
  • Three or fewer spinal levels are involved.

排除标准

  • • Severe canal or foraminal stenosis.
  • Severely dehydrated disc.
  • Allergy to antibiotics or contrast media.
  • Previous spine surgery.

结局指标

主要结局

pain intensity

时间窗: 6 months

measured with the Visual Analog Scale at baseline and at 1,3, and 6 months

functional disability

时间窗: 6 months

measured with the Oswestry Disability Index at baseline and at 1,3, and 6 months

次要结局

  • Procedure-related complications(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sherif M. S. Mowafy

Professor

Zagazig University

研究点 (1)

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