This is a double-blind randomized clinical trial to compare the effect of shock wave therapy on lower limb lymphedema. There are two arms: A) complex decongestive therapy + extracorporeal shock waves therapy; B) complex decongestive therapy plus placebo extracorporeal shock waves.
This is a double blind, randomized, clinical trial. 30 patients with lower limb lymphedema will be randomized in 2 groups. One group will receive the habitual complex decongestive therapy (lymphatic manual drainage and compression) plus extracorporeal shock waves therapy. The other group will receive complex decongestive therapy (lymphatic manual drainage and compression) plus placebo extracorporeal shock waves. Patients in the 2 groups will be instructed on skin care measures and kinesitherapy. The usual manual lymphatic drainage and compression will be applied to the 2 groups. The 2 groups will receive 10 treatment sessions, 2 weekly for 5 weeks. Group complex decongestive therapy + shock waves. Patients will receive treatment with manual lymphatic drainage, compression, and shock waves. Group complex decongestant therapy + placebo. Patients will receive treatment with manual lymphatic drainage, compression, and placebo shock waves. Tolerance and possible adverse effects will be recorded by physiotherapist. Any adverse effect detected will be evaluated by the rehabilitation medical doctor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
30
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Patients will receive treatment sham extracorporeal shock waves.
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Hospital del Mar
Barcelona, Spain
RECRUITINGLimb volume change 1
The difference between limb volume previous of treatment and at the end of treatment
Time frame: 5 weeks
Limb volume change 2
The difference between limb volume from previous of treatment to 1 month after
Time frame: 9 weeks
VAS Pain
Changes in pain at previous treatment, at the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not pain to 10 maximum imaginable)
Time frame: 9 weeks
VAS Heaviness
Changes in heaviness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not heaviness to 10 maximum imaginable)
Time frame: 9 weeks
VAS Hardness
Changes in hardness from previous treatment, to the end of treatment and to 1 month after. Measured by a visual analogue scale (VAS) (from 0 not hardness to 10 maximum imaginable)
Time frame: 9 weeks
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