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Enrolling by Invitation

NCT Number: NCT06879444

"Core Stabilization Strenght and Pelvic Floor Functions in Primary Sjogren's"

This study aims to explain the comparison of core stabilization strength and pelvic floor functions between individuals diagnosed with Sjogren syndrome and a healthy control group.

(Sjogren syndrome group n=27; control group n=27)

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Key information

Conditions

Sjogren Syndrome Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Healthy Volunteers Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–65 year

Sex eligibility

Female

Study type

Observational

Primary location

Pamukkale Üniversitesi

Denizli, 20000, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Sjogren syndrome group:

  • Diagnosed by a rheumatologist
  • Being 18 years of age or older,
  • Agreeing to participate in the study

Control group:

-Being 18 years of age or older,

Exclusion criteria

Sjogren syndrome group and control group:

  • Presence of neurological disease
  • Presence of any orthopedic problem that would affect functionality
  • Presence of a history of orthopedic surgery

Treatment and study plan

Core Muscle testing and patient reported outcome measures

Other

These are the situation evaluation parameters. It presents the data of the participants at the time of evaluation.

Primary outcomes

  1. Pelvic Floor Distress Inventory-20 (PTDE-20)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    There are 20 questions in total on the scale. The best score that can be obtained from the entire survey is "0" and the worst score is "300".

  2. Sexual Life Quality Scale- Women (CYKÖ-K)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    The maximum score that can be obtained from the scale with this system is 108.

  3. Incontinence Impact Questionnaire (IIQ-7) (IES)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    Consists of 7 items. Maximum score is 100.

  4. The McGill trunk muscle endurance test

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    The McGill trunk muscle endurance test is a test group that includes all trunk flexor, extensor and lateral muscle endurance tests.

Secondary outcomes

  1. Health assessment questionnaire (HAQ)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    This questionnaire consists of 20 questions and 8 subheadings, each answer ranging from 0 to 3 points.

  2. Cognitive Exercise Therapy Approach (BETY)

    Time frame: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

    This scale has 30 items. The scale is scored with a 5-point Likert system.

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

"Investigation of 'Core' Stabilization Strength and Pelvic Floor Functions in Individuals with Primary Sjogren: a Controlled Study"

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 17, 2025
Registry last updated
Mar 17, 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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