Efficacy of Transcutaneous Electrical Nerve Stimulation in Patients With Xerostomia (ETENX)
NCT ID: NCT06708195
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2023-09-15
2024-11-20
Brief Summary
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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
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Group experimental
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan
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
Group experimental
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan
Interventions
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Group experimental
Type: Inactive TENS (placebo) Frequency: 1 session Session duration: 15 minutes Application area: Skin over the bilateral parotid glan
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Patient with vertigo, persistent headaches, hearing problems, neuralgias, and/or facial paralysis
18 Years
ALL
No
Sponsors
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Universidad de Murcia
OTHER
Responsible Party
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Pia Lopez Jornet
MD,PhD,DDs
Locations
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Pia Lopez Jornet
Murcia, , Spain
Countries
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References
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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.
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.
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.
Other Identifiers
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ACTA10/2024/CEI
Identifier Type: -
Identifier Source: org_study_id