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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
Academic Vascular Surgery Unit
Hull, Yorkshire, United Kingdom
Maximum Walking Distance (MWD)
Treadmill test
Time frame: 12 weeks
Claudication Distance
Distance covered prior to onset of any symptoms
Time frame: 12 weeks
Changes in Ankle Brachial Pressure Index
Time frame: Week 4, 8 and 12
Changes in Patient reported walking distance
Time frame: Week 4, 8 and 12
Changes in Quality of life [Short form 36(SF36)
Time frame: Week 4, 8 and 12
Changes in Quality of life [EuroQoL (EQ5D)]
Time frame: Week 4, 8 and 12
Subject tolerance of treatment
Questionnaire including visual analogue pain scales
Time frame: Week 4
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