Primary Sjögren's Syndrome (pSS)NCT06989411
Current Therapy in Primary Sjogren's Syndrome
A study testing Clinical pilates exercises +Interferential current therapy (real current) in people with Primary Sjögren's Syndrome (pSS), run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- What is being tested?
- Clinical pilates exercises +Interferential current therapy (real current)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2019to 5 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- Presence of dehydration,
- Pregnancy,
- Using cigarettes and alcohol,
- Cognitive problems that affect cooperation,
- having any other disease that may affect their functions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial
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)
- Being tested
- Clinical pilates exercises +Interferential current therapy (real current), Clinical pilates exercises+ Interferential current therapy (Placebo current)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | treatment group Receives: Other: Clinical pilates exercises +Interferential current therapy (real current) |
| Group II | Placebo comparator | Control Group Receives: Other: Clinical pilates exercises+ Interferential current therapy (Placebo current) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Flow Rate Measurement
Measured: 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.
Measured: 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.
Measured: 5 minutes
Secondary outcomes (5)
Health Assessment Questionnaire
The total score is between 0 and 3. A higher score indicates greater disability.
Measured: 5 minutes
Beck Depression Inventory
Total summed score range of 0-63. High score means high depression
Measured: 7 minutes
Beck Anxiety Inventory
The score range is 0-63. A high score indicates a high level of anxiety.
Measured: 7 minutes
Short Form-36
Each subscale has a score between 0 and 100, and a high score means the good quality of life
Measured: 10 minutes
Pittsburgh Sleep Quality Index
Total score ranges from 0 to 21. High scores indicate poor sleep quality.
Measured: 7 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start14 Jan 2019
- Primary completion20 Nov 2019
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gur Kabul, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989411
- Sponsor's protocol ID
- Current Therapy in pSS
- Status last verified
- May 2025
- First submitted
- 9 May 2025
- Last updated
- 25 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness Of Interferential Current Therapy On Salivary Gland Function In Individuals With Primary Sjogren's Syndrome: Single-Blind Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06989411
- Acronym / sponsor ID
- Current Therapy in pSS
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 20 Nov 2019 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Clinical pilates exercises +Interferential current therapy (real current)treatment group |
| Group II | Placebo comparator | Other: Clinical pilates exercises+ Interferential current therapy (Placebo current)Control Group |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Group I |
| 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) | Other | Group II |
Primary outcome
Salivary Flow Rate Measurement
Time frame: 15 minutes
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.
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.
5 secondary outcomes
Health Assessment Questionnaire
Time frame: 5 minutes
Beck Depression Inventory
Time frame: 7 minutes
Beck Anxiety Inventory
Time frame: 7 minutes
Short Form-36
Time frame: 10 minutes
Pittsburgh Sleep Quality Index
Time frame: 7 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical pilates exercises +Interferential current therapy (real current) in people with Primary Sjögren's Syndrome (pSS), run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Flow Rate Measurement (time frame: 15 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.