Acute Salivary Flow Rate Response to Transcutaneous Electrical Nerve Stimulation Versus Electro-acupuncture

Between available therapies for dry mouth is electrostimulation. Using an extra-oral device like TENS - which result in a statistically significant - increases the quantity of whole salivary flow rate production in xerostomia patients. The use of acupuncture as an alternative treatment modality for xerostomia has been documented in the Western medical field since the 1980s. Observational studies have demonstrated that acupuncture treatment may increase salivary flow in healthy volunteers.

Study Overview

• Status: Unknown
• Conditions: Salivation
• Intervention / Treatment: Device: TENS; Device: electro-acupuncture

Detailed Description

It is possible that an increase of the blood fiux in the salivary glands may be one of the mechanisms behind the positive effect of acupuncture on the metabolism of the salivary glands, which leads to an increase of the salivary fiow.

Transcutaneous electric nerve stimulation (TENS) is a non-pharmacological and well known physical therapy modality which is widely for the acute and chronic pain management.

Electrostimulation using an extraoral device like TENS on parotid gland results in a statistically significant increase in the quantity of whole saliva flow rate production.

Starting a prevention program as early as possible considering the most practical, cost effective and efficient treatments with the best risk-benefit ratio will help to diminish dry mouth symptoms and sequelae.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt
      • Recruiting
      • Faculty of Physical Therapy
      • Contact: ali ismail, lecturer; Phone Number: 02 01005154209

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

100 healthy volunteers above 18 years from both sexes randomly assigned to TENS or electro-acupuncture group.

• (TENS group): Volunteers in this group (n=50) will receive only one session of 5-minute extra-oral TENS applied on bilateral parotid gland with 50 HZ frequency and pulse duration 250microsecons
• (Electro-acupuncture group): Volunteers in this group (n=50) will receive only one session of 5-minute electro-acupuncture on local acu-points St4 and St 7 bilateraly with 2 HZ frequency.

Description

Inclusion Criteria:

- 1) 100 healthy adult volunteers from both sexes. 2) Application time of TENS and electro-acupuncture will be fixed for all volunteers between 9:00 am to 11:00 am.

3) The volunteers will be advised to have nothing to eat, drink, chew gum, coffee intake and oral hygiene before the test at least by one hour

Exclusion Criteria:

• 1) Volunteers under 18 years of age. 2) Pregnant females. 3) Habits (mouth breathing, smoking, alcohol and drug abuse). 4) Cancer patients (patients on chemotherapy/immunotherapy and history of head and neck radiotherapy).

  5) Cardiac patients (cardiac pacemakers and defibrillators). 6) Patients wearing hearing aids. 7) Chronic inflammatory autoimmune disease such as Sjogren's syndrome (an autoimmune disease that induces exocrine dysfunction and abnormalities), other rheumatologic diseases (including: rheumatoid arthritis, Systemic lupus erythematosus, scleroderma, mixed connective tissue disease, etc), sarcoidosis, amyloidosis, Crohn's disease and ulcerative colitis.

  8) Acute oral inflammatory disorders, gingivostomatitis, tonsillitis and dehydration.

  9) Infectious diseases e.g (HIV/AIDS, HCV and Tuberculosis). 10) Patients undergoing the use of any drugs. 11) Patients with neurological disorders: stroke, parkinson's disease, epilepsy, Bell's palsy, Alzheimer's disease, Patients with cerebrovascular problems, patients with a history of aneurysm and patients with transient ischaemia.

  12) Salivary gland diseases and disorders: agenesis of the salivary glands, sialoadenitis and sialolithiasis. Patients with Salivary duct ligation, history of salivary gland pathology, salivary gland inflammation and parotid gland infection.

  13) Psychogenic diseases and conditions: stress, anxiety, nervousness, depression, schizophrenia and eating disorders ( bulimia).

  14) Endocrine diseases: hyperthyroidism, hypothyroidism, Cushing's syndrome and Addison's disease and systemic diseases like diabetes mellitus.

  15) Others: cystic fibrosis, hypertension, fibromyalgia, chronic fatigue syndrome, burning mouth syndrome, primary biliary cirrhosis, liver transplant candidates, renal diseases, renal dialysis, anemia and atrophic gastritis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TENS group; Volunteers in this group (n=50) will receive only one session of 5-minute extra-oral TENS applied on bilateral parotid gland with 50 HZ frequency and pulse duration 250 µs.	Device: TENS; Volunteers in this group (n=50) will receive only one session of 5-minute extra-oral TENS applied on bilateral parotid gland with 50 HZ frequency and pulse duration 250 µs.
electro-acupuncture group; Volunteers in this group (n=50) will receive only one session of 5-minute electro-acupuncture on local acu-points St4 and St 7 bilateraly with 2 HZ frequency.	Device: electro-acupuncture; Volunteers in this group (n=50) will receive only one session of 5-minute electro-acupuncture on local acu-points St4 and St 7 bilateraly with 2 HZ frequency.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
salivary flow rate	It is estimated as follow: By dividing whole resting salivary volume on five minute collection period , thus whole resting salivary flow rate (ml/minute) is obtained (baseline).; Dividing stimulated salivary volume - collected during TENS application - on five minute collection period, thus stimulated salivary flow rate (ml/minute) is obtained.; Assessing improvement is done by comparing stimulated with whole resting salivary flow rate. Any increase in salivary rate will be considered an improvement	during the five-minute TENS session.

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: ali ismail, lecturer, Lecturer PT for Cardiovascular / Respiratory Disorder and Geriatrics

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Anticipated): February 15, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 24, 2019
• First Posted (Actual): December 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 24, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Sialorrhea
• Other Study ID Numbers: P.T.REC/012/002523

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No