Efficacy of Ozone Therapy in Patients With Ankylosing Spondylitis: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- visual analogue scale (VAS)
研究概览
简要总结
The aim of this study was to investigate the effects of rectal ozone therapy added to medical treatment on pain severity, disease activity, spinal mobility, functional status, enthesitis, and quality of life (QoL) in patients with ankylosing spondylitis (AS).
Patients and methods: Patients who fulfilled the modified New York criteria for AS were included in this randomized controlled study. Thirty patients selected according to inclusion and exclusion criteria were randomized into two groups. Rectal ozone treatment along with medical treatment was administered to the patients in group 1, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks. The patients in group 2 continued only their current medical treatment. All patients received a comprehensive rheumatologic assessment including pain severity, disease-specific instruments for disease activity, functional status, spinal mobility, enthesitis score, and QoL.
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
- 否
入选标准
- •Patients who were diagnosed as AS according to the Modified New York criteria
排除标准
- •having other concomitant rheumatic diseases,
- •receiving anti-TNF-α therapy within the last 3 months,
- •being in clinical remission with standard medical treatment,
- •being pregnant,
- •having diseases such as favism, asthma, pancreatitis, and uncontrolled hyperthyroidism for which ozone therapy is contraindicated.
研究组 & 干预措施
Control group
The patients in this group continued only their current medical treatment.
干预措施: Ozone therapy (Other)
Ozone Therapy
Rectal ozone treatment along with medical treatment was administered to the patients in this group, in increasing doses for 5 sessions per week, 20 sessions in total for 4 weeks.
干预措施: Ozone therapy (Other)
结局指标
主要结局
visual analogue scale (VAS)
时间窗: Change from baseline VAS at the 4th week after the treatment
The patients were assessed for low back pain level according to the 10 cm visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain).
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index(Change from baseline Bath Ankylosing Spondylitis Disease Activity Index at the 4th week after the treatment)
- Ankylosing Spondylitis Disease Activity Score(Change from baseline Ankylosing Spondylitis Disease Activity Score at the 4th week after the treatment)
- Bath Ankylosing Spondylitis Functional Index(Change from baseline Bath Ankylosing Spondylitis Functional Index at the 4th week after the treatment)
- Ankylosing Spondylitis Quality of Life(Change from baseline Ankylosing Spondylitis Quality of Life score at the 4th week after the treatment)
研究者
Hakan Alkan
Clinical Professor
Pamukkale University