XerostomiaETENXNCT06708195
Efficacy of Transcutaneous Electrical Nerve Stimulation in Patients With Xerostomia (ETENX)
A study testing Group experimental in people with Xerostomia and Dry Mouth, run by Universidad de Murcia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Xerostomia, Dry Mouth
- What is being tested?
- Group experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2023to 20 Nov 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Present continuous symptoms of dry mouth for more than three months. Ability to attend the necessary visits to carry out the research.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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,
- Conditions
- Xerostomia, Dry Mouth
- Being tested
- Group experimental
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group experimentalDevice
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Group experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Modified Schirmer tear strip Test measured intensity of salivary flow
Test measured intensity of salivary flow
Measured: 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
Measured: 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
Measured: 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 ).
Measured: 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
Quality of oral life. minimun 0 maximum 56 points. As it gets higher, quality of life decreases
Measured: Baseline (day 0) and at 3 weeks (end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start15 Sep 2023
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for XerostomiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Lopez Jornet, Universidad de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06708195
- Sponsor's protocol ID
- ACTA10/2024/CEI
- Acronym
- ETENX
- Status last verified
- Nov 2024
- First submitted
- 20 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 37946598Chandra 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.
PubMed 35360757Sivaramakrishnan 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.
PubMed 29034187