Salivary Flow Rate Response to Electrostimulation in HD Patients

Cairo University (CU)

Status: Unknown

Conditions: Hemodialysis Complication

Treatments: Device: TENS

Study type: Interventional

Funder types: Other

Identifiers

NCT04562519

P.T.REC/012/002679

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

diabetic HD group

Experimental group

Description:

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

Treatment:

Device: TENS

Nondiabetic goup

Active Comparator group

Description:

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

Treatment:

Device: TENS