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Different Level of ECSWT in Post Mastectomy Lymphedema

Different Levels of Energy of Extracorporeal Shock Wave Therapy in Post Masrectomy Lymphedema

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06278298
Enrollment
45
Registered
2024-02-26
Start date
2023-03-01
Completion date
2025-01-01
Last updated
2024-02-26

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

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema, Shock wave, Breast Cancer

Brief summary

to investigate the effectiveness of different dosages of ECSW in the treatment of post mastectomy lymphedema volume and quality of life (Qol)

Detailed description

The treatment program included two sessions per week for eight weeks. This study was approved by the ethical committee faculty of Physical Therapy Cairo University. All patients signed a consent form involves their agreement to participate in this study.

Interventions

DEVICEShockwave

CDT and different dose of shockwave

OTHERCDT

CDT

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

\- Criteria of selecting the patients from hospital included the following; 1. Their ages ranged from 30 to 50 years. 2. All patients were examined carefully by physician before the study procedure. 3. All patients were free from any other pathological conditions or histories of other health abnormalities except arm lymphedema. 4. They had undergone radical or modified radical mastectomy with axillary lymph node dissection with or without radiotherapy intervention. 5. Only ambulant subjects without any aides will be selected. 6. The degree of lymphedema in all subjects was grade 2 to 3 according to the classification of Foldi.(Foldi et al., 2006), (Appendix II ). 7. All patients will be medically stable. 8. Each patient will sign a consent form which in that insures her eligibility in the study. 9. All patients were treated by the same doctor and physiotherapist.

Exclusion criteria

* The subjects had been excluded from the study if they met one of the following criteria; 1. The patients had recurrent malignancy, active infection, and clinical evidence of obstructive venous diseases. 2. Patients contraindicated to ESWT due to bilateral, acute, and chronic inflammation as well as due to metastasis and poor skin condition were excluded. 3. The patients had neurological or orthopedic problems, and diabetes. 4. Patients with primary lymphedema. 5. Cardiopulmonary disease which decrease the patient activites.

Design outcomes

Primary

MeasureTime frameDescription
lymphedema volumetwo monthstape measurment
skin thickness of the armtwo monthsultrasonography

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026