The Application of Intense Therapeutic Ultrasound in Plantar Fasciitis. A Randomized, Non-probabilistic and Superiority Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain reduction
研究概览
简要总结
It was previously hypothesized that patients receiving Intense Therapeutic Ultrasound (ITU) in addition to the standard of care would have a more rapid resolution of pain, faster return to activities, and a decrease in intra- and perifascial lesions.
详细描述
Intense Therapeutic Ultrasound (ITU) is an established ultrasound-based therapy in which sound waves are concentrated and focused into a well-defined specific area of musculoskeletal tissue. Previous researches hipothesize that the application of ITU improve and accelerate healing in patients with chronic 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
- None
盲法说明
Patient located in experimental group will be treated with ITU. Patient located in control group will be treated with the same protocoll of ITU without intensity.
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
- •Both sex patients.
- •Plantar fasciitis diagnosis: pain during walking during the first steps in the morning; pain due to palpation of plantar fasciia insertion.
- •Chronic pain of at least 6 month.
- •Longitudinal thickness of the plantar fasciia more than 4 millimeters.
- •No previous surgery in the plantar fasciia.
- •No previous application of alternative treatments such us shock waves or injections (last ninety days)
排除标准
- •Platelet count disorder or anticoagulation therapy.
- •Anti-inflammatories usual treatment for the treatment of plantar fasciitis.
- •Diabetic foot syndrome.
- •Presence of metabolic disease such us: hypertension, hiper or hipothyroidism.
- •Pregnancy or breastfeeding.
- •Previous treatment with fluoroquinolones antibiotic.
- •Bilateral plantar fasciitis.
- •Diagnosed Autoimmune disesase.
- •Morphofunctional disorders in the foot and ankle.
- •Diagnosed fibromyalgia.
- •Heel disestesy.
结局指标
主要结局
Pain reduction
时间窗: 24 weeks
Use of a Subjective Visual Analogue Scale (SVAS): the outmost left (0 cm) was labelled pain absence and the outmost right (10 cm) was labelled the maximum imagined pain.
Plantar fasciia thickness reduction
时间窗: 24 weeks
Longitudinal view of the plantar fasciia with the use of ultrasound probe.
次要结局
- Hypoechoic volume area reduction(24 weeks)
- Ankle range of motion reduction(24 weeks)
- Time to incorporation to daily live activities(24 weeks)
- Autonomous gait without pain in the heel(24 weeks)
- Improvement of patients satisfaction(24 weeks)
研究者
Raúl Juan Molines Barroso, Phd
Clinical Professor
Universidad Complutense de Madrid