Efficacy of Transcutaneous Electrical Nerve Stimulation in Patients With Xerostomia (ETENX) (ETENX)

November 24, 2024 updated by: Pia Lopez Jornet, Universidad de Murcia

Analysis of the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Xerostomia

Saliva is a complex fluid with essential functions in the oral cavity, such as lubricating tissues, protecting against microorganisms, and facilitating processes like chewing, swallowing, and speaking. Xerostomia, defined as the subjective sensation of dry mouth, is commonly associated with reduced salivary flow, which can lead to intraoral and extraoral complications, including dental caries, periodontal disease, infections, and functional difficulties like chewing, speaking, and swallowing.

Current treatments for xerostomia, such as saliva substitutes and lubricants, provide only temporary relief and do not address the underlying cause. Pharmacological agents like pilocarpine have shown effectiveness in stimulating salivary flow; however, their use is limited by adverse side effects such as excessive sweating and gastrointestinal discomfort.

In this context, transcutaneous electrical nerve stimulation (TENS), a physical therapy traditionally used for pain relief, has shown significant potential in the therapeutic stimulation of salivary glands. TENS is a non-invasive approach that works by stimulating the auriculotemporal nerve, which innervates the parotid glands, promoting an increase in salivary flow.

This study highlights the therapeutic value of TENS as an effective and safe solution for patients with xerostomia. The findings indicate that TENS therapy can increase salivary flow, alleviate symptoms of dry mouth, and significantly improve patients' quality of life, all without the risks and adverse effects associated with pharmacological treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current treatments for xerostomia, such as saliva substitutes and lubricants, provide only temporary relief and do not address the underlying cause. Pharmacological agents like pilocarpine have shown effectiveness in stimulating salivary flow; however, their use is limited by adverse side effects such as excessive sweating and gastrointestinal discomfort.

In this context, transcutaneous electrical nerve stimulation (TENS), a physical therapy traditionally used for pain relief, has shown significant potential in the therapeutic stimulation of salivary glands. TENS is a non-invasive approach that works by stimulating the auriculotemporal nerve, which innervates the parotid glands, promoting an increase in salivary flow.

This study highlights the therapeutic value of TENS as an effective and safe solution for patients with xerostomia. The findings indicate that TENS therapy can increase salivary flow, alleviate symptoms of dry mouth, and significantly improve patients' quality of life,

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30004
        • Pia Lopez Jornet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Present continuous symptoms of dry mouth for more than three months. Ability to attend the necessary visits to carry out the research.

Exclusion Criteria:

Patient subjected to total or partial resection of major salivary glands. Patient with decompensated systemic disease. Patient who has undergone radiotherapy. Patient with motor impairments or issues preventing them from following the operator's instructions.

Patient with vertigo, persistent headaches, hearing problems, neuralgias, and/or facial paralysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I :Experimental

Patients in this group will receive 15 minutes of extraoral TENS applied to the skin over the bilateral parotid glands. The treatment will consist of 3 sessions per week for 3 weeks.

Intervention:

Type: Active TENS Frequency: 3 sessions per week Session duration: 15 minutes Application area: Skin over the bilateral parotid glands
Device: Group experimental
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan
Sham Comparator: Control

Patients in this group will receive 15 minutes of extraoral TENS applied to the skin over the bilateral parotid glands. However, the device will be inactive ( sham ). This treatment will consist of a single session.

Intervention:

Type: Inactive TENS Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glands
Device: Group experimental
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Modified Schirmer tear strip Test measured intensity of salivary flow
Time Frame: Baseline (before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).
Test measured intensity of salivary flow
Baseline (before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).
The Modified Schirmer tear strip Test measured intensity of salivary flow
Time Frame: baseline (day 0 before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).
Test measured intensity of salivary flow
baseline (day 0 before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).
Test Thomson xerostomy
Time Frame: Baseline (day 0 prior to the first session) and at 3 weeks (end of treatment)
Xerostomia Inventory. the higher the outcome, quality of life decreases
Baseline (day 0 prior to the first session) and at 3 weeks (end of treatment)
Visual Analogue Scale (VAS) for xerostomia severity
Time Frame: Baseline (day 0 before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).
Visual Analogue Scale (VAS) for xerostomia severity (0 cm: no xerostomía , 10cm : very severe xerostomia ).
Baseline (day 0 before the start of each session) and immediately after each session, for a total of 3 sessions over 3 weeks (6 measurements in total: Days 0, 7, and 14).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OHIP-14 questionnaire
Time Frame: Baseline (day 0) and at 3 weeks (end of treatment)
Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Baseline (day 0) and at 3 weeks (end of treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Actual)

November 20, 2024

Study Completion (Actual)

November 20, 2024

Study Registration Dates

First Submitted

November 20, 2024

First Submitted That Met QC Criteria

November 24, 2024

First Posted (Estimated)

November 27, 2024

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 24, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTA10/2024/CEI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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