Extracorporeal Shockwave Therapy in the Treatment of Intermittent Claudication Symptoms in Peripheral Vascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Maximum Walking Distance (MWD)
研究概览
简要总结
Peripheral arterial disease is a common condition affecting approximately 64% of 56-77 year olds. This condition restricts bloody supply to calf muscles. Pain occurs after walking a short distance and increases in intensity until the person stops, where the pain then gradually subsides. It can be limiting or occasionally debilitating and has been shown to have considerable deleterious effects of patients quality of life. Shock wave therapy has been shown to promote new blood vessel formation and improved healing amongst other findings. This study aims to identify whether shock wave therapy that is applied to the calf muscles causes such an effect to improve the blood supply to the calf muscles, reduce pain, improve walking ability and quality of life.
详细描述
This study aims to compare the effects of extracorporeal shockwave therapy (ESWT) to placebo with use of a sham control group on walking distances in subjects with lower limb intermittent calf claudication. Extracorporeal shockwave therapy will be applied using the PiezoWave2 shockwave system. All applications will be in adherence to the manufacturer's instructions and provided by trained staff. The device will be targeted at the gastrocnemius muscles of the affected lower leg for several minutes at each treatment session. Participants in control group will undergo the identical process as if treatment were being given but with the shockwaves not being administered and a sham device alternatively used. Participants will have several assessments prior to and after the shockwave treatment in order to quantify the effect. Assessments will include Maximum Walking Distance (MWD), Claudication Distance (CD) and Quality of life questionnaires.
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 (Participant, 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 with unilateral or bilateral intermittent calf claudication (stable for the last 3 months).
- •Able to give written informed consent to participate in the study
- •Age > 18
- •Able to adhere to protocol and attend all follow up appointments
- •Currently receiving "best medical therapy" - anti-platelet and statin medication
排除标准
- •Current malignancy
- •Allergies or intolerances of either anti-platelet medication or statin therapy
- •Pregnancy (pregnancy test performed at screening if necessary)
- •Metal implant near to treatment area
- •Anti-coagulation medication (i.e. Warfarin)
研究组 & 干预措施
Control
Sham treatment in identical format to treatment arm but without shockwave production
干预措施: Extracorporeal shockwave therapy (Device)
Shockwave
Active shockwave treatment to calf muscle bulk
干预措施: Extracorporeal shockwave therapy (Device)
结局指标
主要结局
Maximum Walking Distance (MWD)
时间窗: 12 weeks
Treadmill test
次要结局
- Changes in Ankle Brachial Pressure Index(Week 4, 8 and 12)
- Changes in Patient reported walking distance(Week 4, 8 and 12)
- Claudication Distance(12 weeks)
- Changes in Quality of life [Short form 36(SF36)(Week 4, 8 and 12)
- Changes in Quality of life [EuroQoL (EQ5D)](Week 4, 8 and 12)
- Subject tolerance of treatment(Week 4)