Shock Wave Therapy for Lower Limb Lymphedema

ConditionLymphedema, Lower Limb

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorParc de Salut Mar

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with lower limb lymphedema

Lymphedema of at least 6 months of evolution

The lymphedema must affect at least the knee to the foot

Moderate or severe lymphedema (grades 2 or 3)

Disqualifiers

Under 18 years of age

Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.)

Current or previous deep vein thrombosis of the lower extremity

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

Extracorporeal shock wave therapy by radial device
Device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
Placebo extracorporeal shock wave therapy by radial device
Device
Patients will receive treatment sham extracorporeal shock waves.
DLT
Other intervention
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: DLT + ESWTExperimental treatment 2 interventions

Group B: DLT + Sham ESWTSham comparator 2 interventions

Trial outcomes

Primary outcomes

Limb volume change 1

The difference between limb volume previous of treatment and at the end of treatment

Time frame

5 weeks

Secondary outcomes

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

Other outcomes

Water composition

Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after.

Time frame

9 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Parc de Salut Mar

Lead sponsor

Source ClinicalTrials.gov

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