CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
TENSdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03151889
NCT03151889N/ACompleted

Transcutaneous Electric Nerve Stimulation (TENS) Treatment for Hipossalivation Induced by Radiotherapy

Federal University of Health Science of Porto Alegre·interventional·Posted May 12, 2017·Updated Aug 12, 2020

In Brief

A clinical study evaluating TENS for Hyposalivation and 3 related conditions. Completed, enrolled 67 participants across 1 site.

Detailed Summary

Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMay 12, 2017
Enrollment StartAug 30, 2017
Primary CompletionNov 30, 2017
Study CompletionDec 30, 2018
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 9.1 years ago

Interventions

TENSdevice

TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.