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Extracorporeal schok wave therapy on breast cancer-related lymphdema

Extracorporeal schok wave therapy on breast cancer-related lymphdema

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-427kc5t
Enrollment
Unknown
Registered
2022-02-22
Start date
2021-09-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast-cancer related lymphedema

Interventions

The 20 participants with lymphedema secondary to breast cancer will be randomly allocated into two groups where they received the interventions Complex Physical Therapy and Shockwave Therapy associate
Frequency from 5 to 10Hz
plastic tip of 34mm
For average energy of 0. 08mJ/cm²
number of shots: 1000 if whole limb. Next, Complex Physical Therapy will be performed with skin care orientations, manual lymphatic drainage in the path of the axilloaxillary anastomoses (anterior and
E02.779

Sponsors

Centro Universitário das Faculdades Associadas de Ensino - FAE
Lead Sponsor
Carci - Indústria e Comércio de Aparelhos Cirúrgicos e Ortopédicos
Collaborator
Ibramed - Industria Brasileira de Equipamentos Médicos
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Participants with secondary upper limb lymphedema after breast cancer (identified by the truncated cone formula, considered lymphedema when the difference in limb volume is greater than 200 ml); Age between 18 and 65 years; (Higher incidence of breast cancer in this age group); Female gender (higher population affected by this type of neoplasm)

Exclusion criteria

Exclusion criteria: Decompensated heart disease or metabolic disorders; Skin lesions such as dermatitis and dermatosis; History of deep vein thrombosis; Smokers; Participants who had electronic implants, such as cardiac pacemakers.

Design outcomes

Primary

MeasureTime frame
Difference in limb volume with and without lymphedema measured by the truncated cone formula, considering lymphedema when the difference in limb volume is greater than 200 ml. The primary outcome is expected to be a reduction of at least 10% of the initial volume presented.;Difference between the limb with lymphedema and without the presence of lymphedema as measured by the thickness of the subcutaneous tissue using ultrasonography. The Healcerion Sonon 300L ultrasound will be used. Through it it will be possible to measure the thickness of the subcutaneous tissue in two points: 10 cm above the olecranon, following a straight line along the humerus; and the other point 10 cm below the humeral head in a straight line along the humerus. A minimum 10% reduction in the thickness of the subcutaneous tissue presented is expected as a secondary endpoint.

Countries

Brazil

Contacts

Public ContactLaura Rezende

Centro Universitário das Faculdades Associadas de Ensino - FAE

rezendelaura@hotmail.com+551936380240

Outcome results

None listed

Source: REBEC (via WHO ICTRP)