Current Therapy in Primary Sjogren's Syndrome

The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial

Purpose:The aim of the study was to investigate the effectiveness of interferential current therapy on salivary gland function in Primary Sjogren's Syndrome (pSS).

Methods:Thirty six pSS were included in the study. Patients were randomly divided into 2 groups (Group 1 (treatment group) n=18; Group II (placebo group) n=18). Salivary flow rate measurement (SFRM), Oral Health-Related Quality of Life-United Kingdom Questionnaire (OHRQOL-UK), Oral Health Impact Profile-14 (OHIP-14), Health Assessment Questionnaire (HAQ), Beck Anxiety Inventory (BAI), Beck Depression Inventory (BDI), Pittsburgh Sleep Quality Index (PSQI) and Short Form-36 (SF-36) were used for evaluation. All evaluations were done pre-, posttreatment, at 3. month, at 6. month and at 9. month. Clinical pilates exercises and interferential current therapy were applied to Group I while clinical pilates exercises and interferential current therapy as placebo was applied to Group II. All treatments were given three times a week for 8 weeks.

Study Overview

• Status: Completed
• Conditions: Primary Sjögren's Syndrome (pSS)
• Intervention / Treatment: Other: Clinical pilates exercises +Interferential current therapy (real current); Other: Clinical pilates exercises+ Interferential current therapy (Placebo current)

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • None Selected
    • Usak, None Selected, Turkey, 64200
      • Uşak University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• To be diagnosed with pSS according to the 2016 European League Against Rheumatism American / College of Rheumatology Classification Criteria,
• To be in the 3rd and 4th grade according to the Chisholm-Mason Grading System,
• be in the age range of 25-65 years,
• To be stable on drug use for at least 3 months or longer, (f) To have agreed to participate in the study.

Exclusion Criteria:

• To use antipsychotic, antidepressant, antihypertensive, medical agent for Parkinson's,
• Presence of viral infection,
• Presence of Diabetes Mellitus,
• Receiving head and neck radiotherapy/chemotherapy,
• Having a head and neck malignancy,
• Having undergone head and neck surgery,
• Presence of dehydration,
• Pregnancy,
• Using cigarettes and alcohol,
• Cognitive problems that affect cooperation,
• having any other disease that may affect their functions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; treatment group	Other: Clinical pilates exercises +Interferential current therapy (real current); All treatments were given three times a week for 8 weeks. The current intensity was determined as the mA CC level that the patient felt at the maximum but did not feel any discomfort.
Placebo Comparator: Group II; Control Group	Other: Clinical pilates exercises+ Interferential current therapy (Placebo current); All treatments were given three times a week for 8 weeks. The current intensity was set to 0.1 mA CC (necessary for the machine to work)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary Flow Rate Measurement		15 minutes
Oral Health Impact Profile-14	Total score is between 0 and 56. A high score indicates that the quality of life related to oral and dental health decreases.	5 minutes
Oral Health-Related Quality of Life-United Kingdom Questionnaire	Total scores range from 16 to 80. A high score indicates that the quality of life related to oral and dental health is high.	5 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Assessment Questionnaire	The total score is between 0 and 3. A higher score indicates greater disability.	5 minutes
Beck Depression Inventory	Total summed score range of 0-63. High score means high depression	7 minutes
Beck Anxiety Inventory	The score range is 0-63. A high score indicates a high level of anxiety.	7 minutes
Short Form-36	Each subscale has a score between 0 and 100, and a high score means the good quality of life	10 minutes
Pittsburgh Sleep Quality Index	Total score ranges from 0 to 21. High scores indicate poor sleep quality.	7 minutes

Collaborators and Investigators

• Sponsor: Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): November 20, 2019
• Study Completion (Actual): October 5, 2023

Study Registration Dates

• First Submitted: May 9, 2025
• First Submitted That Met QC Criteria: May 16, 2025
• First Posted (Actual): May 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 16, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: Current Therapy in pSS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No