Different Level of ECSWT in Post Mastectomy Lymphedema

NCT ID: NCT06278298

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-01
• Study Completion Date: 2025-01-01

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.

Conditions

Lymphedema of Upper Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

Shockwave

Group Type: EXPERIMENTAL

Shockwave

Intervention Type: DEVICE

CDT and different dose of shockwave

Group B

Shockwave

Group Type: EXPERIMENTAL

Shockwave

Intervention Type: DEVICE

CDT and different dose of shockwave

Group C

CDT

Group Type: PLACEBO_COMPARATOR

CDT

Intervention Type: OTHER

CDT

Interventions

Shockwave

CDT and different dose of shockwave

Intervention Type: DEVICE

CDT

CDT

Intervention Type: OTHER

Other Intervention Names

CDT

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Christina Sabry

Senior Physical Therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Haytham M Elhafez

Role: STUDY_DIRECTOR

faculty of physical therapy

Locations

Cairo University

Giza, Dokki, Egypt

Countries

Egypt

Other Identifiers

REC/012/003318

Identifier Type: -

Identifier Source: org_study_id