Salivary Flow Rate Response to Electrostimulation in HD Patients

Hemodialysis Complication Clinical Trial

Official title:

Hyposalivation Response to TENS in HD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04562519
• Other study ID #: P.T.REC/012/002679
• Status: Recruiting
• Phase: N/A
• Start date: January 2017
• Est. completion date: May 2021

Study information

• Verified date: November 2020
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Xerostomia is a subjective complaint of dry mouth, whereas hyposalivation is an objective decreased of salivary flow. Hyposalivation was reported in 28.8 % of haemodialysis (HD) patients (Bruzda-Zwiech, 2014).

Description:

Stimulation of the salivary glands can be induced mechanically (for example, by chewing gum or acupressure) or through medications (such as pilocarpine, cevimeline, angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers) or by electrostimulation as transcutnaeous electrical nerve stimulation (TENS) (Bossola and Tazza, 2012).

Eighty HD patients (40 diabetics and 40 nondiabetics) will receive 20 minutes of TENS on skin over bilateral parotid gland, 3 times weekly for 3 weeks to investigate the hyposalivation response of diabetic and non diabetic HD patients to TENS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Eighty HD patients (40 diabetics and 40 non diabetics)

• HD at least from three month

• saliva flow less than or equal 0.15 millilitre per minute

Exclusion Criteria:

• pulmonary or cardiac disorders

• drugs to treat hyposalivation

• salivary glands inflammation, tumor, and autoimmune diseases.

• smokers and alcholics

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

Device:
• TENS
Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)

Locations

Country	Name	City	State
Egypt	Cairo Unoversity	Giza
Egypt	Faculty of Physical Therapy Cairo University	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	3-week response of salivary flow rate	the patients will be ordered to spit saliva in a graduated test tube for 5 minutes after the last session (session number 9). To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.	immediately after the last session
Secondary	immediate response of saliva flow	the patients will be ordered to spit saliva in a graduated test tube for 5 minutes immediately after the first session . To calculate salivary flow rate: saliva volume will be divided on duration of saliva spitting.	immediately after the first session