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

NCT04211324 | Unknown

• 1 other identifier: P.T.REC/012/002523
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Salivation

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

TENS 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.

TENS group

electro-acupuncture 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.

electro-acupuncture group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: self-representation of gender identity card
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• \- 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.
• \) 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

You may not qualify if:

• \) 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).
• \) 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.
• \) Acute oral inflammatory disorders, gingivostomatitis, tonsillitis and dehydration.
• \) 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.
• \) 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.
• \) Psychogenic diseases and conditions: stress, anxiety, nervousness, depression, schizophrenia and eating disorders ( bulimia).
• \) Endocrine diseases: hyperthyroidism, hypothyroidism, Cushing's syndrome and Addison's disease and systemic diseases like diabetes mellitus.
• \) 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of physical therapy

Giza, Dokki, Egypt

RECRUITING

MeSH Terms

Conditions

Sialorrhea

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• ali ismail, lecturer

  Lecturer PT for Cardiovascular / Respiratory Disorder and Geriatrics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ali ismail, lecturer

CONTACT

02-01005154209; ali.mohamed@pt.cu.edu.eg

Ashimaa abdelazim, lecturer

CONTACT

02 01033771553

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of physical therapy for cardiovascular/respiratory disorder and geriaterics-faculty of physical therapy

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 26, 2019
• Study Start: November 4, 2019
• Primary Completion: February 15, 2020
• Study Completion: March 1, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Locations

EG (1)