Hospital del Mar
Barcelona, 08003, Spain
Location status: Recruiting
Location contact
Ana V Lobato, PT
SUB_INVESTIGATOR
Esther Duarte, PhD
CONTACT
Marina Alvarez, MD
SUB_INVESTIGATOR
Mercedes Piqueras, PT
SUB_INVESTIGATOR
Roser Belmonte, PhD
CONTACT
NCT Number: NCT06454734
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Barcelona, 08003, Spain
Location status: Recruiting
Ana V Lobato, PT
SUB_INVESTIGATOR
Esther Duarte, PhD
CONTACT
Marina Alvarez, MD
SUB_INVESTIGATOR
Mercedes Piqueras, PT
SUB_INVESTIGATOR
Roser Belmonte, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Other names: Radial ESWT, rESWT
Patients will receive treatment sham extracorporeal shock waves.
Other names: Radial ESWT, rESWT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Other names: Decongestive Lymphatic Therapy
Time frame: 5 weeks
The difference between limb volume previous of treatment and at the end of treatment
Time frame: 9 weeks
The difference between limb volume from previous of treatment to 1 month after
Time frame: 9 weeks
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
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
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
Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after.
Contact information is provided by the study sponsor or research team.
Esther Duarte, MD, PhD
CONTACT
Roser Belmonte, MD, PhD
CONTACT
Parc de Salut Mar
Other
Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy: Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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