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CompletedNCT04667676Updated Jan 13, 2021

Respiratory Functions Response To Tens Acupoint Stimulation Post Inhalation Injury

An interventional study of acupoint TENS in Inhalation Injury, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-01-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2018, registered Dec 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Inhalation Injury
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 40 is close to the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with any other pulmonary condition
  • Cardiac condition
  • Rib fracture
  • Systemic disease
  • Local infection and cigarette or tobacco use
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    TENS Therapy Group

    patients received acupoint TENS

    Device: acupoint TENS

  • Sham comparator
    Control group

    patients received shame acupoint TENS

    Device: acupoint TENS

Interventions

  • Deviceacupoint 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

06

What researchers measure

Primary outcomes

  1. Spirometer

    • Portable spirometer to measure forced vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) from setting position.

    Time frame: 4 weeks

07

Study locations

1 site
  • Marwa Eid
    Cairo, 2011, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04667676
Lead sponsor
Cairo University
Responsible party
Marwa Eid (assistant professor of physical therapy for surgery, Cairo University) — Principal investigator
First posted
Dec 16, 2020
Start date
Jun 10, 2018
Primary completion
Nov 20, 2018
Completion
Jan 20, 2019
Last update
Jan 13, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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