Primary Sjögren's Syndrome (pSS)
Conditions
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.
Interventions
OTHERClinical 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.
OTHERClinical 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)
Sponsors
Pamukkale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The physiotherapist performing the evaluation was blinded to the groups.
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Short Form-36 | 10 minutes | Each subscale has a score between 0 and 100, and a high score means the good quality of life |
| Health Assessment Questionnaire | 5 minutes | The total score is between 0 and 3. A higher score indicates greater disability. |
| Pittsburgh Sleep Quality Index | 7 minutes | Total score ranges from 0 to 21. High scores indicate poor sleep quality. |
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed