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Clinical Trials/NCT06278298
NCT06278298
Active, not recruiting
Not Applicable

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

Cairo University1 site in 1 country45 target enrollmentStarted: March 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
45
Locations
1
Primary Endpoint
lymphedema volume

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

lymphedema volume

Time Frame: two months

tape measurment

skin thickness of the arm

Time Frame: two months

ultrasonography

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christina Sabry

Senior Physical Therapist

Cairo University

Study Sites (1)

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