- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07552103
The Effect of Thyroid Dysfunction
June 1, 2026 updated by: Zülal TATAR, Pamukkale University
The Effect of Thyroid Dysfunction on Pain, Symptoms, Attitudes, Fatigue, Foot Parameters, Muscle Strength, and Lower Limb Performance in Women With a Menstrual Cycle: A Cross-Sectional Comparative Study
The aim of this study is to investigate the effect of thyroid dysfunction on pain, symptoms, attitudes, fatigue, foot parameters, muscle strength, and lower extremity performance in women with a menstrual cycle, and to compare these findings with those of healthy controls.
Study Overview
Status
Enrolling by invitation
Conditions
Study Type
Observational
Enrollment (Estimated)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Uşak, Turkey (Türkiye)
- Usak Training and Research Hospital, Endocrinology Outpatient Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
The study population will consist of menstruating women diagnosed with hypothyroidism or hyperthyroidism who apply to the Endocrinology Outpatient Clinic of Usak Training and Research Hospital, and menstruating women who are companions of patients applying to the same clinic for the healthy control group, who meet the inclusion criteria and agree to participate in the study.
Description
Inclusion Criteria:
- Be between the ages of 18 and 55
- Be female
- Be able to communicate in Turkish
- Be willing to participate in the study
- Have signed the informed consent form
- Have a menstrual cycle
Exclusion Criteria:
- Diagnosed with severe cognitive impairment or dementia
- Having an active psychiatric diagnosis
- Having undergone any surgery in the past year
- Having any rheumatic, neurological, or cancer-related condition
- Using a walking aid
- Having a cardiopulmonary condition that could cause significant functional limitations
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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hypothyroid group
This group includes patients diagnosed with hypothyroidism.
Participants will undergo clinical assessments and data collection.
No intervention will be applied.
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hyperthyroidism group
This group includes patients diagnosed with hyperthyroidism.
Participants will undergo clinical assessments and data collection.
No intervention will be applied.
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healthy group
This group includes healthy patients.
Participants will undergo clinical assessments and data collection.
No intervention will be applied.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sit-to-Stand Test
Time Frame: At baseline (Day 1)
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This test evaluates individuals' lower extremity muscle strength and functional performance.
In the starting position, the participant's arms are crossed in front of the torso and their feet are in full contact with the floor.
Participants are asked to sit down and stand up as quickly as possible for 30 seconds from a standard chair with back support but no armrests.
The total number of sit-to-stand cycles is recorded.
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At baseline (Day 1)
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Trunk Flexor Endurance Test
Time Frame: At baseline (Day 1)
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The participant lies down with the hips and knees flexed to 90°, arms crossed over the chest at shoulder level, and feet in a fixed position.
The test begins when the participant's trunk is moved into a supported sitting position with 60° flexion while maintaining this initial position.
The trunk support is removed, and the participant is asked to maintain this position for as long as possible.
The test ends when the 60° angle between the floor and the upper trunk changes, and the elapsed time is recorded in seconds.
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At baseline (Day 1)
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Trunk Lateral Flexor Endurance Test
Time Frame: At baseline (Day 1)
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The participant lies on their non-dominant side on a treatment table with their legs extended.
The upper foot is placed in front of the lower foot for support.
The upper arm is placed across the chest toward the opposite shoulder.
The elbow of the lower arm is positioned in flexion and placed so that support can be obtained from the elbow and forearm.
The participant is instructed to lift their hips off the ground to form a straight line with their entire body, using support from their elbows and feet.
The test ends when the participant loses the test position, and the duration for which the position was maintained is recorded in seconds.
The test is performed bilaterally.
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At baseline (Day 1)
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Longitudinal Arch Measurement
Time Frame: At baseline (Day 1)
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This method, which describes the position of the navicular tubercle relative to the medial malleolus and the line of the first metatarsophalangeal joint, was first developed by McPoil and colleagues.
The grading of pes planus is based on the degree to which the navicular tubercle deviates from the Feiss line and approaches the ground.
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At baseline (Day 1)
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Foot Function Index
Time Frame: At baseline (Day 1)
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This is a patient-reported outcome measure based on a patient-centered assessment approach that evaluates foot function from different perspectives.
It consists of 23 items divided into three subscales: pain, disability, and activity limitation.
For each item, patients are asked to rate their condition on a scale from 0 (no pain or difficulty) to 10 (the most severe pain imaginable or extreme difficulty making the activity impossible to perform).
Scores for each subscale are calculated separately, and a total score is also recorded.
The scores are transformed to a scale ranging from 0 to 100, where 0 represents the best possible outcome (no pain or difficulty) and 100 represents the worst possible outcome (the most severe pain imaginable or extreme difficulty making the activity impossible to perform).
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At baseline (Day 1)
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Foot Posture Index-6
Time Frame: At baseline (Day 1)
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The Foot Posture Index (FPI) is an assessment tool used to evaluate foot posture by observing the position of the rearfoot and forefoot across multiple planes.
This assessment, which takes approximately 4-5 minutes, was performed bilaterally based on observation and palpation from the posterior, medial, lateral, and anterior aspects of the foot.
A total of six parameters were evaluated, including three related to the rearfoot and three related to the forefoot.
Each parameter was scored on a scale from -2 to +2, and both the total score and the subscores for the forefoot and rearfoot were recorded.
The total score was used for interpretation, where 0 indicates a neutral foot posture, positive values indicate a pronated foot posture, and negative values indicate a supinated foot posture.
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At baseline (Day 1)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Menstrual Symptom Scale
Time Frame: At baseline (Day 1)
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The Menstrual Symptom Scale will be used to assess symptoms associated with the menstrual period.
This scale is divided into three subscales-"Negative Effects/Somatic Complaints," "Menstrual Pain," and "Coping Strategies for Menstrual Pain"-and consists of a total of 24 items.
Participants will be asked to rate the symptoms they experience related to menstruation on a scale from 1 (never) to 5 (always).
An increase in the mean score is directly proportional to the severity of menstrual symptoms.
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At baseline (Day 1)
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Visual Analog Scale
Time Frame: At baseline (Day 1)
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This is used to convert certain values that cannot be measured numerically into a numerical format.
The two extremes of the parameter being assessed are labeled at either end of a 10-cm line, and participants are asked to indicate where their condition falls on this line by drawing a line, placing a dot, or making a mark.
In our study, the intensity of pain experienced during menstruation (at rest, during activity, and while sleeping) will be defined as 0 = "no pain" and 10 = "severe pain."
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At baseline (Day 1)
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Menstrual Attitude Scale
Time Frame: At baseline (Day 1)
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This scale is a Likert-type measure consisting of 33 items.
It consists of five subscales that examine the positive and negative aspects of menstruation: (a) Menstruation as a debilitating phenomenon (Items: 1-12); (b) Menstruation as a distressing phenomenon (Items: 13-18); c.
Menstruation as a natural phenomenon (Items 19-22).
d.
Anticipating or sensing the onset of menstruation (Items 23-26).
e. Denial of the effects of menstruation (Items 27-33)).
Higher scores indicate a positive attitude toward menstruation.
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At baseline (Day 1)
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Time up and go test
Time Frame: At baseline (Day 1)
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This test is a performance-based measure of functional mobility.
Participants stand up from a standard chair without using the armrests.
They then walk 3 meters as quickly as possible (without running), turn around, walk back to the chair, and sit down again.
Participants stand up from a standard chair without using the armrests.
They then walk 3 meters as quickly as possible (without running), turn around, walk back to the chair, and sit down again.
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At baseline (Day 1)
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Multidimensional Fatigue Inventory-20
Time Frame: At baseline (Day 1)
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The Multidimensional Fatigue Inventory-20 (MFI-20) is a self-report questionnaire consisting of 20 items developed to assess different dimensions of fatigue.
The instrument comprises five subscales: General Fatigue, Physical Fatigue, Mental Fatigue, Reduced Motivation, and Reduced Activity, with each subscale containing four items.
Each item is rated on a 5-point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree).
Subscale scores are calculated by summing the scores of the four items within each subscale, resulting in a score range of 4 to 20 for each dimension.
Higher scores indicate greater levels of fatigue or greater impairment in the respective dimension.
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At baseline (Day 1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2026
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
April 20, 2026
First Submitted That Met QC Criteria
April 20, 2026
First Posted (Actual)
April 27, 2026
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Other Study ID Numbers
- Thyroid Dysfunction
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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