CompletedNot Applicable

Current Therapy in Primary Sjogren's Syndrome

Turkey (Türkiye)36 participantsStarted 2019-01-14

Plain-language 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.

Who can participate

Age range

25 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Salivary Flow Rate Measurement

Timeframe: 15 minutes

Oral Health Impact Profile-14

Timeframe: 5 minutes

Oral Health-Related Quality of Life-United Kingdom Questionnaire

Timeframe: 5 minutes

Trial details

NCT IDNCT06989411

SponsorPamukkale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-11-20

View on ClinicalTrials.gov More Primary Sjögren's Syndrome (pSS) trials