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Completed

NCT Number: NCT06708195

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pia Lopez Jornet

Murcia, 30004, Spain

About this study

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,

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group experimental

Device

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

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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 ).

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Official study title

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

Acronym: ETENX

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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