Different Level of ECSWT in Post Mastectomy Lymphedema

Cairo University (CU)

Status: Active, not recruiting

Conditions: Lymphedema of Upper Limb

Treatments: Other: CDT; Device: Shockwave

Study type: Interventional

Funder types: Other

Identifiers

NCT06278298

REC/012/003318

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

Shockwave

Treatment:

Device: Shockwave

Group B

Experimental group

Description:

Shockwave

Treatment:

Device: Shockwave

Group C

Placebo Comparator group

Description:

CDT

Treatment:

Other: CDT