Thyroid DysfunctionNCT07552103
The Effect of Thyroid Dysfunction
An observational study of Thyroid Dysfunction, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Thyroid Dysfunction
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 1 Aug 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Usak Training and Research Hospital, Endocrinology Outpatient Clinic
Uşak
About this study
Official title: 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.
- Conditions
- Thyroid Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hypothyroid group | This group includes patients diagnosed with hypothyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied. | |
| hyperthyroidism group | This group includes patients diagnosed with hyperthyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied. | |
| healthy group | This group includes healthy patients. Participants will undergo clinical assessments and data collection. No intervention will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Foot Function Index
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).
Measured: At baseline (Day 1)
Foot Posture Index-6
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.
Measured: At baseline (Day 1)
Sit-to-Stand Test
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.
Measured: At baseline (Day 1)
Trunk Flexor Endurance Test
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.
Measured: At baseline (Day 1)
Trunk Lateral Flexor Endurance Test
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.
Measured: At baseline (Day 1)
Longitudinal Arch Measurement
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.
Measured: At baseline (Day 1)
Secondary outcomes (5)
Menstrual Symptom Scale
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.
Measured: At baseline (Day 1)
Visual Analog Scale
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."
Measured: At baseline (Day 1)
Menstrual Attitude Scale
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.
Measured: At baseline (Day 1)
Multidimensional Fatigue Inventory-20
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.
Measured: At baseline (Day 1)
Time up and go test
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.
Measured: At baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Jun 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DysfunctionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zülal TATAR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552103
- Sponsor's protocol ID
- Thyroid Dysfunction
- Status last verified
- Apr 2026
- First submitted
- 20 Apr 2026
- Last updated
- 17 Sep 2026
- 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 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07552103
- Acronym / sponsor ID
- Thyroid Dysfunction
- Conditions
- Thyroid Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 27 Apr 2026 (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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hypothyroid group | – | –This group includes patients diagnosed with hypothyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied. |
| hyperthyroidism group | – | –This group includes patients diagnosed with hyperthyroidism. Participants will undergo clinical assessments and data collection. No intervention will be applied. |
| healthy group | – | –This group includes healthy patients. Participants will undergo clinical assessments and data collection. No intervention will be applied. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Foot Function Index
Time frame: At baseline (Day 1)
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).
Foot Posture Index-6
Time frame: At baseline (Day 1)
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.
Sit-to-Stand Test
Time frame: At baseline (Day 1)
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.
Trunk Flexor Endurance Test
Time frame: At baseline (Day 1)
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.
Trunk Lateral Flexor Endurance Test
Time frame: At baseline (Day 1)
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.
Longitudinal Arch Measurement
Time frame: At baseline (Day 1)
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.
5 secondary outcomes
Menstrual Symptom Scale
Time frame: At baseline (Day 1)
Visual Analog Scale
Time frame: At baseline (Day 1)
Menstrual Attitude Scale
Time frame: At baseline (Day 1)
Multidimensional Fatigue Inventory-20
Time frame: At baseline (Day 1)
Time up and go test
Time frame: At baseline (Day 1)
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 17 Sep 2026.
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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?
An observational study of Thyroid Dysfunction, 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 6 inclusion and 6 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 17 Sep 2026. 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. 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?
Foot Function Index (time frame: At baseline (Day 1)). The study lists 6 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 17 Sep 2026.