Comparison of the Efficiency of Extracorporeal Shock Wave Therapy and Ultrasound-Guided Ozone Injection in Patients With Chronic Plantar Fasciitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Visual Analog Scale
研究概览
简要总结
Extracorporeal Shock Wave Therapy (ESWT) is a conservative treatment method that has been widely used in musculoskeletal diseases in recent years. Its mechanism is to provide hyperstimulation and vascularity increase with the help of acoustic waves focused on a specific area, thus accelerating healing and reducing pain. This method, which is frequently used in plantar fasciitis, is frequently applied to patients whose symptoms persist despite first-line treatment strategies.
Ozone injections have been frequently used in musculoskeletal disorders in recent years and are mainly used in osteoarthritis, osteomyelitis, tendon, fascia and ligament injuries, vertebra and disc pathologies and neuropathic pain. Analgesic effect on musculoskeletal system (release of endorphins, activation of antinociceptive system, reduction of edema) anti-inflammatory effect (regulation of cytokine release, reduction of superoxide radicals, modulation of prostaglandin), regulation of local oxygenation and circulation, tissue repair (neutralization of preteolytic enzymes, fibroblast proliferation) and has an antimicrobial effect. Although it is also used in the treatment of plantar fasciitis, there are limited articles on this subject in the literature.
In our study, it was aimed to compare the effectiveness of ESWT and ozone injection therapy, which are two treatment strategies with regenerative action mechanisms, in patients with resistant plantar fasciitis.
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
- Double (Investigator, Outcomes Assessor)
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
- •Be over 18 years old
- •Heel pain lasting longer than 3 months
- •Localized pain and tenderness on palpation on the medial aspect of the calcaneal tuberosity when the ankle is fully dorsiflexed.
- •In the first step of walking, >50 mm according to VAS. and description of pain
- •Presence of plantar fasciitis typical findings on ultrasonography (thickening more than 4 mm in the proximal plantar fascia with changes in fibril pattern)
- •Failure to respond to conservative treatment before (nonsteroidal anti-inflammatory drugs, stretching, heel cushion, shoe modifications, orthotics, cold, heat, taping, massage)
排除标准
- •being under the age of 18
- •Any skin lesions in the heel area
- •Inflammatory, rheumatic arthritis
- •Having a history of fracture, trauma or operation in the heel area
- •Systemic infection or malignancy
- •Having a pacemaker
- •Local injection to the heel area in the last 6 months or use of topical or oral nonsteroidal anti-inflammatory drugs in the last 2 weeks
结局指标
主要结局
Visual Analog Scale
时间窗: pre-treatment, immediately post-treatment and three months follow-up
measurement for pain severity, It is a value between 0-100. "0" means no pain and "100" means maximum pain.
次要结局
- plantar fascia thickness(pre-treatment, immediately post-treatment and three months follow-up)
- Foot Function İndex(pre-treatment, immediately post-treatment and three months follow-up)
研究者
Berke Aras
Associate Professor
Ankara City Hospital Bilkent