To hear about similar clinical trials, please enter your email below
Trial Title:
Different Level of ECSWT in Post Mastectomy Lymphedema
NCT ID:
NCT06278298
Condition:
Lymphedema of Upper Limb
Conditions: Official terms:
Lymphedema
Conditions: Keywords:
Lymphedema, Shock wave, Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Device
Intervention name:
Shockwave
Description:
CDT and different dose of shockwave
Arm group label:
Group A
Arm group label:
Group B
Other name:
CDT
Intervention type:
Other
Intervention name:
CDT
Description:
CDT
Arm group label:
Group C
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.
Criteria for 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.
Gender:
Female
Gender based:
Yes
Minimum age:
30 Years
Maximum age:
60 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cairo University
Address:
City:
Giza
Zip:
12612
Country:
Egypt
Start date:
March 1, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Cairo University
Agency class:
Other
Source:
Cairo University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06278298
