Salivary Flow Rate Response to Electrostimulation in HD Patients

Not Applicable

• Conditions: Hemodialysis Complication
• Interventions: Device: TENS

• Registration Number: NCT04562519
• Lead Sponsor: Cairo University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-09-18
• Study First Posted: 2020-09-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-06
• Last Update Posted: 2020-11-09
• Primary Completion: 2021-04-01
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetic HD group	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)
Nondiabetic goup	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)

Primary Outcome Measures

Name	Time	Method
3-week response of salivary flow rate	immediately after the last session	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.

Secondary Outcome Measures

Name	Time	Method
immediate response of saliva flow	immediately after the first session	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.

Trial Locations

Locations (2)

Faculty of Physical Therapy Cairo University; 🇪🇬 Giza, Dokki, Egypt

Cairo Unoversity; 🇪🇬 Giza, Egypt