Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
36 participants
INTERVENTIONAL
2019-01-14
2023-10-05
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group I
treatment group
Clinical 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.
Group II
Control Group
Clinical 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)
Interventions
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Clinical 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.
Clinical 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)
Eligibility Criteria
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Inclusion 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
* 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.
25 Years
65 Years
ALL
No
Sponsors
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Pamukkale University
OTHER
Responsible Party
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Elif Gur Kabul
principal investigator
Locations
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Usak University
Uşak, None Selected, Turkey (Türkiye)
Countries
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Other Identifiers
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Current Therapy in pSS
Identifier Type: -
Identifier Source: org_study_id
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