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

Salivation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211324
• Other study ID #: P.T.REC/012/002523
• Status: Recruiting
• Start date: November 4, 2019
• Est. completion date: March 1, 2020

Study information

• Verified date: December 2019
• Source: Cairo University
• Contact: ali ismail, lecturer
• Phone: 02-01005154209
• Email: ali.mohamed[@]pt.cu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Salivation
• Sialorrhea

Intervention

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
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.

Locations

Country	Name	City	State
Egypt	Faculty of physical therapy	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.