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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04667676
Other study ID # 4-12-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 10, 2018
Est. completion date January 20, 2019

Study information

Verified date December 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

this study designed to examine the effect of Acu-TENS applied bilaterally on Ding Chuan acupoint to boost pulmonary functions, improve diaphragmatic excursion and decrease dyspnea in patients with inhalation injuries.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 20, 2019
Est. primary completion date November 20, 2018
Accepts healthy volunteers No
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Partial or full-thickness major burns - Diagnosis of smoke inhalation based on the history of smoke exposure and chest computed tomography (CT) - Have no systemic disease - Body mass index less than 30. Exclusion Criteria: - Patients with any other pulmonary condition - Cardiac condition - Rib fracture - Systemic disease - Local infection and cigarette or tobacco use

Study Design


Intervention

Device:
acupoint TENS
TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 µs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks

Locations

Country Name City State
Egypt Marwa Eid Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spirometer • Portable spirometer to measure forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) from setting position. 4 weeks
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