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Completed

NCT Number: NCT06989411

Current Therapy in Primary Sjogren's Syndrome

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.

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Key information

Conditions

Primary Sjögren's Syndrome (pSS)

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Usak University

Uşak, None Selected, 64200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clinical pilates exercises +Interferential current therapy (real current)

Other

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)

Other

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)

Primary outcomes

  1. Salivary Flow Rate Measurement

    Time frame: 15 minutes

  2. Oral Health Impact Profile-14

    Time frame: 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.

  3. Oral Health-Related Quality of Life-United Kingdom Questionnaire

    Time frame: 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 outcomes

  1. Health Assessment Questionnaire

    Time frame: 5 minutes

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

  2. Beck Depression Inventory

    Time frame: 7 minutes

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

  3. Beck Anxiety Inventory

    Time frame: 7 minutes

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

  4. Short Form-36

    Time frame: 10 minutes

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

  5. Pittsburgh Sleep Quality Index

    Time frame: 7 minutes

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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2023
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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