Current Therapy in Primary Sjogren's Syndrome

Pamukkale University36 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Primary Sjögren's Syndrome (pSS)

Interventions

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Salivary Flow Rate Measurement

Time frame: 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.

Time frame: 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.

Time frame: 5 minutes

Secondary Outcomes

Health Assessment Questionnaire

The total score is between 0 and 3. A higher score indicates greater disability.

Time frame: 5 minutes

Beck Depression Inventory

Total summed score range of 0-63. High score means high depression

Time frame: 7 minutes

Beck Anxiety Inventory

The score range is 0-63. A high score indicates a high level of anxiety.

Time frame: 7 minutes

Short Form-36

Each subscale has a score between 0 and 100, and a high score means the good quality of life

Time frame: 10 minutes

Pittsburgh Sleep Quality Index

Total score ranges from 0 to 21. High scores indicate poor sleep quality.

Time frame: 7 minutes

Current Therapy in Primary Sjogren's Syndrome

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes