Clinical trial NCT06708195: Efficacy of Transcutaneous Electrical Nerve Stimulation in Patients With Xerostomia (ETENX)
Official title: Analysis of the Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Xerostomia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Xerostomia
Dry Mouth
Lead sponsor: Universidad de Murcia
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group Control group
Primary purpose: TREATMENT

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.

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,

Eligibility criteria: 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

Primary outcomes:
measure: The Modified Schirmer tear strip Test measured intensity of salivary flow
timeFrame: 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).
measure: The Modified Schirmer tear strip Test measured intensity of salivary flow
timeFrame: 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).
measure: Test Thomson xerostomy
timeFrame: Baseline (day 0 prior to the first session) and at 3 weeks (end of treatment)
measure: Visual Analogue Scale (VAS) for xerostomia severity
timeFrame: 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:
measure: OHIP-14 questionnaire
timeFrame: Baseline (day 0) and at 3 weeks (end of treatment)
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Pia Lopez Jornet
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.