Lymphedema, Lower Limb
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEExtracorporeal shock wave therapy by radial device
Patients will receive treatment by extracorporeal shock waves therapy (ESWT).
DEVICEPlacebo extracorporeal shock wave therapy by radial device
Patients will receive treatment sham extracorporeal shock waves.
OTHERDLT
Patients will receive treatment with decongestive lymphatic therapy (DLT: manual lymphatic drainage, compression)
Sponsors
Parc de Salut Mar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Patients, outcome assessors and investigators will not know if received treatment was placebo or therapeutic. The physiotherapist will apply the treatment according to a list of random numbers generated to make 2 treatment groups
Intervention model description
Double blind randomized clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Sign the informed consent
Exclusion criteria
* Under 18 years of age * Coagulation disorders (hemophilia, treatment with acenocoumarol, etc.) * Current or previous deep vein thrombosis of the lower extremity * Pregnancy * Electronic implantable medical devices as pacemaker implants, medication pumps, etc * Having received treatment with complex decongestive therapy or shock waves during the last 6 months * Treatment with corticosteroids or radiotherapy in the area to be treated in the last 6 weeks * Active oncological disease in the area to be treated * Active infectious-inflammatory process in the area to be treated * Cognitive or sensory deficits that prevent collaboration * Inability to walk independently or inability to attend therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limb volume change 1 | 5 weeks | The difference between limb volume previous of treatment and at the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limb volume change 2 | 9 weeks | The difference between limb volume from previous of treatment to 1 month after |
| VAS Pain | 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) |
| VAS Heaviness | 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) |
| VAS Hardness | 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Water composition | 9 weeks | Changes in water lower limb composition at previous treatment, to the end of treatment anto 1 month after. |
Countries
Spain
Contacts
Primary ContactRoser Belmonte, MD, PhD
Backup ContactEsther Duarte, MD, PhD
Outcome results
None listed