Back to resultsRespiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Primary Purpose
Inhalation Injury
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
acupoint TENS
Sponsored by
About this trial
This is an interventional treatment trial for Inhalation Injury
Eligibility Criteria
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
Sites / Locations
- Marwa Eid
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TENS Therapy Group
Control group
Arm Description
patients received acupoint TENS
patients received shame acupoint TENS
Outcomes
Primary Outcome Measures
Spirometer
• Portable spirometer to measure forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) from setting position.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04667676
Brief Title
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Official Title
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
November 20, 2018 (Actual)
Study Completion Date
January 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS Therapy Group
Arm Type
Experimental
Arm Description
patients received acupoint TENS
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
patients received shame acupoint TENS
Intervention Type
Device
Intervention Name(s)
acupoint TENS
Intervention Description
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
Primary Outcome Measure Information:
Title
Spirometer
Description
• Portable spirometer to measure forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) from setting position.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Marwa Eid
City
Cairo
ZIP/Postal Code
2011
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury
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