Current Therapy in Primary Sjogren's Syndrome

Not Applicable

Completed

• Conditions: Primary Sjögren's Syndrome (pSS)

• Registration Number: NCT06989411
• Lead Sponsor: Pamukkale University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-14
• Primary Completion: 2019-11-20
• Study Completion: 2023-10-05
• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-16
• Last Update Submitted: 2025-05-16
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Usak University; 🇹🇷 Usak, None Selected, Turkey