Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06454734
Status:
RECRUITING
Last Update Posted:
2024-06-12
First Post:
2024-05-28
Brief Title:
Shock Wave Therapy for Lower Limb Lymphedema
Sponsor:
Parc de Salut Mar
Organization:
Parc de Salut Mar
Study Overview
Official Title:
Lower Limb Lymphedema Treatment by Extracorporeal Shock Wave Therapy Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None