Clinical trial NCT06989411: Current Therapy in Primary Sjogren's Syndrome
Official title: The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Sjögren's Syndrome (pSS)
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2025-05-25
Enrollment: 36
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Salivary Flow Rate Measurement
timeFrame: 15 minutes
measure: Oral Health Impact Profile-14
timeFrame: 5 minutes
measure: Oral Health-Related Quality of Life-United Kingdom Questionnaire
timeFrame: 5 minutes
Secondary outcomes:
measure: Health Assessment Questionnaire
timeFrame: 5 minutes
measure: Beck Depression Inventory
timeFrame: 7 minutes
measure: Beck Anxiety Inventory
timeFrame: 7 minutes
measure: Short Form-36
timeFrame: 10 minutes
measure: Pittsburgh Sleep Quality Index
timeFrame: 7 minutes
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University
state: None Selected
Study officials:
References: