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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04749342
Other study ID # P.T.REC/012/002271
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date May 1, 2021

Study information

Verified date July 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to: Find out the efficacy of using complete decongestive physiotherapy on limb volume in advanced secondary upper and lower extremity lymphedema patients. Find out the efficacy of compression bandaging on limb volume in advanced lymphedema patients. This study was conducted to compare between the efficacy of complete decongestive therapy (CDT) and compression bandaging in advanced secondary lower extremity lymphedema.


Description:

The study was conducted at the department of plastic surgery, Kasr Al-Ainy hospital. Sixty patients of both genders aged from 40 to 55 years old were participated in this study, and they were randomly assigned to two study groups. Group I: Thirty patients received CDT (60 min of manual lymph drainage MLD, compression bandaging, exercises, and skin care). Group II: Thirty patients received compression bandaging alone. The same bandaging scheme used for both groups. The therapy included 12 interventions performed 5 days a week, during the first two weeks in addition to another successive two sessions at the third week, i.e., for a total of twelve sessions. Evaluation of limb volume using water volumetry and 4-cm truncated cone circumferential measurements were done before treatment application, after 6 sessions (post 1) and after 12 sessions (post 2).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2021
Est. primary completion date March 1, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 55 Years
Eligibility Inclusion Criteria: Patients with lower limb lymphedema (stage II and III) secondary lymphedema aged from 40 to 55 years old, with BMI less than 35 and duration of illness ranged from 3-9 years were included in the study Exclusion Criteria: the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.

Study Design


Related Conditions & MeSH terms

  • Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes
  • Lymphedema

Intervention

Other:
Physiotherapy Treatment
Physical Therapy sessions for treatment of advanced Lymphedema Cases

Locations

Country Name City State
Egypt cairo University Cairo Dokky, Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahmed Mohamed Abdelrauf

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Limb Volume girth Limb Measurement 1 Month