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

NCT ID: NCT04211324

Last Updated: 2019-12-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-04

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Salivation

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

TENS

Intervention Type DEVICE

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.

electro-acupuncture

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of physical therapy for cardiovascular/respiratory disorder and geriaterics-faculty of physical therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ali ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Lecturer PT for Cardiovascular / Respiratory Disorder and Geriatrics

Locations

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Faculty of physical therapy

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ali ismail, lecturer

Role: CONTACT

Phone: 02-01005154209

Email: [email protected]

Ashimaa abdelazim, lecturer

Role: CONTACT

Phone: 02 01033771553

Facility Contacts

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ali ismail, lecturer

Role: primary

Other Identifiers

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P.T.REC/012/002523

Identifier Type: -

Identifier Source: org_study_id