Different Level of ECSWT in Post Mastectomy Lymphedema

NCT06278298 | Active Not Recruiting DMC

• 1 other identifier: REC/012/003318
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema, Shock wave, Breast Cancer

Outcome Measures

Primary Outcomes (2)

• lymphedema volume

  tape measurment

  two months

• skin thickness of the arm

  ultrasonography

  two months

Study Arms (3)

Group A

EXPERIMENTAL

Shockwave

Device: Shockwave

Group B

EXPERIMENTAL

Shockwave

Device: Shockwave

Group C

PLACEBO COMPARATOR

CDT

Other: CDT

Interventions

Shockwave DEVICE

CDT and different dose of shockwave

Also known as: CDT

Group A; Group B

CDT OTHER

CDT

Group C

Eligibility Criteria

• Age: 30 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Dokki, 12612, Egypt

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Haytham M Elhafez

  faculty of physical therapy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physical Therapist

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

EG (1)