Comparison of Ultrasound-Guided Local Ozone Injection and Extracorporeal Shock Wave Therapy in the Treatment of Chronic Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Pain intensity (Visual Analog Scale, VAS)
研究概览
简要总结
This randomized controlled clinical trial compares ultrasound-guided local ozone injection, extracorporeal shock wave therapy, and conventional conservative treatment in patients with chronic Achilles tendinopathy. The study focuses on changes in pain, functional outcomes, and overall clinical improvement during the follow-up period.
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)
盲法说明
Outcome assessors are blinded to group allocation. No other parties are masked in this study.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 65 years.
- •Patients with a diagnosis of Achilles tendinopathy confirmed by ultrasonography or magnetic resonance imaging (MRI).
- •Patients with persistent symptoms despite completion of conservative treatment.
- •Volunteers who agree to participate in the study.
排除标准
- •Patients with symptoms lasting less than 12 weeks.
- •Presence of contraindications to extracorporeal shock wave therapy (ESWT), including pregnancy; history of thrombosis; use of anticoagulant medications; coagulation disorders such as hemophilia; systemic conditions; or localized conditions at the treatment site such as active infection or malignant tumors.
- •Presence of contraindications to local ozone injection, including pregnancy; glucose-6-phosphate dehydrogenase (G6PD) deficiency; favism; uncontrolled hyperthyroidism; thrombocytopenia; severe cardiovascular conditions; and use of angiotensin-converting enzyme (ACE) inhibitors.
- •History of neurological disease, muscle disease, or peripheral vascular disease.
- •Presence of congenital or acquired deformities of the knee and/or ankle.
- •Receipt of physical therapy modalities applied to the Achilles tendon within the last 6 weeks.
- •Receipt of any therapeutic injection to the Achilles tendon within the last 12 weeks.
- •History of direct trauma to the symptomatic Achilles tendon or Achilles tendon rupture.
- •History of surgical treatment involving the Achilles tendon or ankle for any reason.
- •History of foot or ankle dislocation or fracture within the past 1 year.
- •Presence of systemic inflammatory diseases that may affect tendon structure, such as ankylosing spondylitis, reactive arthritis, or psoriatic arthritis.
- •Patients with isolated insertional Achilles tendinopathy without tenderness in the mid-portion of the tendon
研究组 & 干预措施
Ultrasound-Guided Ozone Injection
Participants receive ultrasound-guided local ozone injection administered to the affected Achilles tendon according to a standardized treatment protocol.
干预措施: Ultrasound-Guided Local Ozone Injection (Other)
Extracorporeal Shock Wave Therapy (ESWT)
Participants receive extracorporeal shock wave therapy applied to the affected Achilles tendon according to a standardized treatment protocol.
干预措施: Extracorporeal Shock Wave Therapy (ESWT) (Device)
Conventional Conservative Treatment
Participants receive conventional conservative treatment consisting of a standardized exercise program and activity modification.
干预措施: Conventional Conservative Treatment (Other)
结局指标
主要结局
Pain intensity (Visual Analog Scale, VAS)
时间窗: Baseline, post-treatment, and 12 weeks after treatment
Pain intensity is assessed using the Visual Analog Scale (VAS).
Pain intensity assessed by Visual Analog Scale (VAS)
时间窗: Baseline, post-treatment, and 12-week follow-up
The Visual Analog Scale (VAS) is used to assess subjective pain intensity related to Achilles tendon pain.
次要结局
- Victorian Institute of Sports Assessment-Achilles (VISA-A) score(Baseline, post-treatment, and 12-week follow-up)
- Roles and Maudsley Score (RMS)(Baseline, post-treatment, and 12-week follow-up)
研究者
Berna Orhan
medical doctor
Ankara City Hospital Bilkent