Different Level of ECSWT in Post Mastectomy Lymphedema

Lymphedema of Upper Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06278298
• Other study ID #: REC/012/003318
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 45
• Est. completion date: January 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Limb

Intervention

Device:
• Shockwave
CDT and different dose of shockwave

Other:
• CDT
CDT

Locations

Country	Name	City	State
Egypt	Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lymphedema volume	tape measurment	two months
Primary	skin thickness of the arm	ultrasonography	two months