Current Therapy in Primary Sjogren's Syndrome

NCT06989411 | Completed

• 1 other identifier: Current Therapy in pSS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Sjögren's Syndrome (pSS)

Outcome Measures

Primary Outcomes (3)

• Salivary Flow Rate Measurement

  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.

  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.

  5 minutes

Secondary Outcomes (5)

• 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

Study Arms (2)

Group I

EXPERIMENTAL

treatment group

Other: Clinical pilates exercises +Interferential current therapy (real current)

Group II

PLACEBO COMPARATOR

Control Group

Other: Clinical pilates exercises+ Interferential current therapy (Placebo current)

Interventions

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.

Group I

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)

Group II

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Usak University

Uşak, None Selected, 64200, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The physiotherapist performing the evaluation was blinded to the groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 25, 2025
• Study Start: January 14, 2019
• Primary Completion: November 20, 2019
• Study Completion: October 5, 2023
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

TU (1)