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Salivary Flow Rate Response to Electrostimulation in HD Patients

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04562519
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
51.9
Anticipated Duration (Months)
40
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: TENS
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Hyposalivation Response to TENS in HD Patients
Actual Study Start Date :
Jan 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: diabetic HD group

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

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)
Active Comparator: Nondiabetic goup

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

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)

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Physical Therapy Cairo University Giza Dokki Egypt
2 Cairo Unoversity Giza Egypt

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Ali Ismail, lecturer, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ali Mohamed Ali ismail, lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University
ClinicalTrials.gov Identifier:
NCT04562519
Other Study ID Numbers:
  • P.T.REC/012/002679
First Posted:
Sep 24, 2020
Last Update Posted:
Nov 9, 2020
Last Verified:
Nov 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 9, 2020