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

NCT06708195 | Completed

• 1 other identifier: ACTA10/2024/CEI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Xerostomia; Dry Mouth

Outcome Measures

Primary Outcomes (4)

• The Modified Schirmer tear strip Test measured intensity of salivary flow

  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

  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

  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

  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 Outcomes (1)

• OHIP-14 questionnaire

  Baseline (day 0) and at 3 weeks (end of treatment)

Study Arms (2)

Group I :Experimental

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

Control

SHAM COMPARATOR

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

Interventions

Group experimental DEVICE

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

Control; Group I :Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Pia Lopez Jornet

Murcia, 30004, Spain

Location

Related Publications (3)

• Khamdi S, Matangkasombut O, Lam-Ubol A. Non-pharmacologic interventions for management of radiation-induced dry mouth: A systematic review. Oral Dis. 2024 Jul;30(5):2876-2893. doi: 10.1111/odi.14804. Epub 2023 Nov 9.

  PMID: 37946598 BACKGROUND

• Chandra R, Bhakta P, Beniwal J, Dhanda R, Saxena V, Sinha S. Evaluation of the efficacy of transcutaneous electrical nerve stimulation (TENS) on salivary flow rate in patients with xerostomia - A case control study. J Family Med Prim Care. 2022 Feb;11(2):767-771. doi: 10.4103/jfmpc.jfmpc_922_21. Epub 2022 Feb 16.

  PMID: 35360757 BACKGROUND

• Sivaramakrishnan G, Sridharan K. Electrical nerve stimulation for xerostomia: A meta-analysis of randomised controlled trials. J Tradit Complement Med. 2017 Feb 14;7(4):409-413. doi: 10.1016/j.jtcme.2017.01.004. eCollection 2017 Oct.

  PMID: 29034187 BACKGROUND

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

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: MD,PhD,DDs

Model Details: Experimental group Control group

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 27, 2024
• Study Start: September 15, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)