NCT04667676

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2019

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

January 13, 2021

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 4, 2020

Last Update Submit

January 11, 2021

Conditions

Inhalation Injury

Outcome Measures

Primary Outcomes (1)

  • Spirometer

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

    4 weeks

Study Arms (2)

TENS Therapy Group

EXPERIMENTAL

patients received acupoint TENS

Device: acupoint TENS

Control group

SHAM COMPARATOR

patients received shame acupoint TENS

Device: acupoint TENS

Interventions

acupoint TENSDEVICE

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

Control groupTENS Therapy Group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marwa Eid

Cairo, 2011, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy for surgery

Study Record Dates

First Submitted

December 4, 2020

First Posted

December 16, 2020

Study Start

June 10, 2018

Primary Completion

November 20, 2018

Study Completion

January 20, 2019

Last Updated

January 13, 2021

Record last verified: 2020-12

Locations

EG(1)