The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Salivary Flow Rate Measurement
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The physiotherapist performing the evaluation was blinded to the groups.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group I
treatment group
干预措施: Clinical pilates exercises +Interferential current therapy (real current) (Other)
Group II
Control Group
干预措施: Clinical pilates exercises+ Interferential current therapy (Placebo current) (Other)
结局指标
主要结局
Salivary Flow Rate Measurement
时间窗: 15 minutes
Oral Health Impact Profile-14
时间窗: 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
时间窗: 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.
次要结局
- Health Assessment Questionnaire(5 minutes)
- Beck Depression Inventory(7 minutes)
- Beck Anxiety Inventory(7 minutes)
- Short Form-36(10 minutes)
- Pittsburgh Sleep Quality Index(7 minutes)
研究者
Elif Gur Kabul
principal investigator
Uşak University