Femoro Acetabular ImpingementNCT06198829
Evaluation of the Clinical Parameters and Kinesiophobia in Femoroacetabular Impingement Syndrome
An observational study of Femoro Acetabular Impingement, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Due to the limited number of studies investigating the relationship between kinesiophobia, radiographic parameters, and clinical outcomes in patients with Femoroacetabular Impingement Syndrome (FAIS) in the literature, the aim of this study is to evaluate the relationship between kinesiophobia and clinical parameters… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Femoro Acetabular Impingement
- What is being tested?
- Physical examination tests and surveys
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Feb 2024to 30 Dec 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Our study will include 23 patients diagnosed with FAI between the ages of 18 and 65 who have agreed to participate in the study. All participants will receive detailed information about the study, and a written informed consent form will be provided for them to voluntarily sign, indicating their acceptance of participating in the study. Participants will be individuals who are not candidates for surgery during the treatment process and will be selected from patients who have not undergone surgery before. The inclusion criteria involve receiving a diagnosis of 'cam' type femoroacetabular impingement syndrome through radiographic and physical examination assessments.
Who may be able to join
- Being between the ages of 18 and 65
- Being diagnosed with 'cam' type femoroacetabular impingement syndrome
- Having no surgical history in the hip area and its vicinity within the last 1 year
- Having filled out the informed consent form
Who cannot join
- Having a history of psychological and mental illness
- Having another illness with symptoms that may overlap with FAI symptoms
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acibadem Atasehir Hospital
Istanbul, Atasehir, 34758
About this study
Official title: The Evaluation of the Relationship Between Clinical Parameters and Kinesiophobia in Patients With Femoroacetabular Impingement Syndrome
Due to the limited number of studies investigating the relationship between kinesiophobia, radiographic parameters, and clinical outcomes in patients with Femoroacetabular Impingement Syndrome (FAIS) in the literature, the aim of this study is to evaluate the relationship between kinesiophobia and clinical parameters in patients with FAIS.
Read the detailed description
Femoroacetabular Impingement Syndrome (FAIS) is defined as a condition in which abnormalities in the femoral and acetabular anatomy lead to abnormal contact and mechanical forces along the joint, resulting in labral and chondral pathologies.
Symptomatic patients with Femoroacetabular Impingement Syndrome (FAIS) typically present with pain, primarily in the groin but also potentially in the lower back, hip, and posterior thigh. In addition to pain, patients may complain of a mechanically perceptible 'click' sound, locking sensation, or instability in the hip. Symptoms particularly worsen with activities such as squatting, hip rotation, sitting, climbing stairs, and prolonged sitting. The resulting symptoms lead to a decrease in functional capacities related to physical activities.
The radiographic measurements of the FAIS-Cam deformity are typically done using the alpha angle. An angle of 58 degrees or higher is considered abnormal. However, abnormal morphology is not always indicative of a pathological lesion. A holistic approach, including patient symptoms and a physical examination, is necessary for a comprehensive assessment.
In patients with Femoroacetabular Impingement Syndrome (FAIS), hip biomechanics notably change during activities such as walking, squatting, and climbing stairs. Due to pain, individuals with FAIS may exhibit protective behaviors, such as keeping the hip in flexion or adopting a Trendelenburg gait to avoid loading forces on the extremity. This situation can lead to kinesiophobia, defined as an exaggerated fear of movement and avoidance behavior based on the belief that movement may lead to injury. In patients with FAIS, it is believed that high levels of kinesiophobia are associated with lower physical function.
The participants' sociodemographic information will be recorded using a Sociodemographic Information Form. For pain assessment, the Visual Analog Scale and Algometer will be employed. Joint range of motion will be measured using the Clinometer mobile application, hip asymmetry will be assessed through the Weight Bearing Asymmetry Test using a scale, movement fear will be gauged using the Tampa Kinesiophobia Scale, and hip dysfunction will be evaluated using the Harris Hip Score. Additionally, the "Sit-to-Stand Test" will be utilized for functional measurement. The alpha angle for patients will be evaluated through pelvic anteroposterior radiography.
- Conditions
- Femoro Acetabular Impingement
- Being tested
- Physical examination tests and surveys
- Keywords
- Pain, Kinesiophobia, Weight-Bearing, Femoracetabular Impingement
- Medical subject headings
- Femoracetabular Impingement, Pain, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examination tests and surveysOther
Patients'hip joint range of motion range of motion, pain levels, pressure-pain threshold levels, kinesiophobia levels, and hip dysfunction levels will be measured, and the alpha angle will be evaluated on hip radiographs.
| Study group | Role | What they receive |
|---|---|---|
| Clinical parameter assessment group | Various assessments will be conducted on patients with femoroacetabular cam impingement. Receives: Other: Physical examination tests and surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tampa Kinesiophobia Scale
The scale is a questionnaire consisting of 17 questions applicable to musculoskeletal disorders, encompassing parameters related to work-associated activities, injury/reinjury, and fear-avoidance. The scale employs a 4-point Likert rating, where 1= Strongly Disagree and 4= Strongly Agree. After reversing the scoring of items 4, 8, 12, and 16, a total score is derived. The scale yields a total score ranging from 17 to 68. A high score on the scale indicates a high level of kinesiophobia.
Measured: One day (The assessments will be conducted once)
Secondary outcomes (4)
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) will be used for subjective measurement. The scale is created with a 10 cm line, with 'No Pain' written at one end and 'Unbearable Pain' at the other. The patient is asked to mark their pain intensity on this line. The portion from the 0 point to where the patient marks provides the score
Measured: One day (The assessments will be conducted once)
Pressure-pain Threshold Levels
For objective pain measurement, an Algometer (Baseline®) will be utilized. The Algometer is a calibrated pressure device with a 1 cm round plastic-tipped end, measured in kg/cm2. It is used to measure pain associated with pressure thresholds.While applying pressure to the body with this plastic disc, the indicator needle progresses clockwise in kg. The measurement concludes when the participant feels pain, and the maximum tolerance point, obtainable in kg, is recorded.
Measured: One day (The assessments will be conducted once)
Harris Hip Score
Harris Hip Score has been developed to measure disability in various hip problems. The questionnaire includes parameters that assess pain, function, absence of deformity, and joint range of motion. The pain domain queries the area of pain, pain intensity, activities affected by pain, and the need for medication. The function domain assesses daily activities and walking. The deformity domain includes hip movements and measurements of limb length. The joint range of motion evaluates hip mobility. The questionnaire consists of 10 items and is scored out of a maximum of 100. A higher score indicates less dysfunction.
Measured: One day (The assessments will be conducted once)
30 Second Sit to Stand Test
The Sit-to-Stand test is employed for various purposes, including the measurement of postural control, fall risk, lower extremity strength, balance, and disability. It is suggested that the Sit-to-Stand test may serve as an indicator of lower extremity strength. The test requires a chair with a height of approximately 44 cm and back support, along with a stopwatch. When seated, the patient's feet should touch the ground, and their hands are placed crossed on their shoulders. Two practice trials are allowed before the test. The patient is instructed to stand up and sit down as quickly as possible. When standing, the hips and knees should be in full extension, and when sitting, the hips should make full contact with the chair. The number of times the patient can transition from sitting to an erect position within 30 seconds is recorded.Sitting and standing less than 10 times in 30 seconds indicates lower extremity weakness.
Measured: One day (The assessments will be conducted once)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start6 Feb 2024
- Primary completion10 Jun 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro Acetabular ImpingementStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yagmur Kucuk, Istanbul Medipol University Hospital
- Investigators
- Gulay Aras Bayram, Assist.Prof., Study director, Istanbul Medipol University School of Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198829
- Sponsor's protocol ID
- ACU-FTR-YK-01
- Status last verified
- Feb 2024
- First submitted
- 28 Dec 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Relationship Between Clinical Parameters and Kinesiophobia in Patients With Femoroacetabular Impingement Syndrome
- ClinicalTrials.gov ID
- NCT06198829
- Acronym / sponsor ID
- ACU-FTR-YK-01
- Conditions
- Femoro Acetabular Impingement
- Keywords
- Pain, Kinesiophobia, Weight-Bearing, Femoracetabular Impingement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 10 Jan 2024 (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.
Due to the limited number of studies investigating the relationship between kinesiophobia, radiographic parameters, and clinical outcomes in patients with Femoroacetabular Impingement Syndrome (FAIS) in the literature, the aim of this study is to evaluate the relationship between kinesiophobia and clinical parameters in patients with FAIS.
Detailed description
Femoroacetabular Impingement Syndrome (FAIS) is defined as a condition in which abnormalities in the femoral and acetabular anatomy lead to abnormal contact and mechanical forces along the joint, resulting in labral and chondral pathologies.
Symptomatic patients with Femoroacetabular Impingement Syndrome (FAIS) typically present with pain, primarily in the groin but also potentially in the lower back, hip, and posterior thigh. In addition to pain, patients may complain of a mechanically perceptible 'click' sound, locking sensation, or instability in the hip. Symptoms particularly worsen with activities such as squatting, hip rotation, sitting, climbing stairs, and prolonged sitting. The resulting symptoms lead to a decrease in functional capacities related to physical activities.
The radiographic measurements of the FAIS-Cam deformity are typically done using the alpha angle. An angle of 58 degrees or higher is considered abnormal. However, abnormal morphology is not always indicative of a pathological lesion. A holistic approach, including patient symptoms and a physical examination, is necessary for a comprehensive assessment.
In patients with Femoroacetabular Impingement Syndrome (FAIS), hip biomechanics notably change during activities such as walking, squatting, and climbing stairs. Due to pain, individuals with FAIS may exhibit protective behaviors, such as keeping the hip in flexion or adopting a Trendelenburg gait to avoid loading forces on the extremity. This situation can lead to kinesiophobia, defined as an exaggerated fear of movement and avoidance behavior based on the belief that movement may lead to injury. In patients with FAIS, it is believed that high levels of kinesiophobia are associated with lower physical function.
The participants' sociodemographic information will be recorded using a Sociodemographic Information Form. For pain assessment, the Visual Analog Scale and Algometer will be employed. Joint range of motion will be measured using the Clinometer mobile application, hip asymmetry will be assessed through the Weight Bearing Asymmetry Test using a scale, movement fear will be gauged using the Tampa Kinesiophobia Scale, and hip dysfunction will be evaluated using the Harris Hip Score. Additionally, the "Sit-to-Stand Test" will be utilized for functional measurement. The alpha angle for patients will be evaluated through pelvic anteroposterior radiography.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical parameter assessment group | – | Other: Physical examination tests and surveysVarious assessments will be conducted on patients with femoroacetabular cam impingement. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Our study will include 23 patients diagnosed with FAI between the ages of 18 and 65 who have agreed to participate in the study. All participants will receive detailed information about the study, and a written informed consent form will be provided for them to voluntarily sign, indicating their acceptance of participating in the study. Participants will be individuals who are not candidates for surgery during the treatment process and will be selected from patients who have not undergone surgery before. The inclusion criteria involve receiving a diagnosis of 'cam' type femoroacetabular impingement syndrome through radiographic and physical examination assessments.
Key inclusion criteria (4 listed)
- Being between the ages of 18 and 65
- Being diagnosed with 'cam' type femoroacetabular impingement syndrome
- Having no surgical history in the hip area and its vicinity within the last 1 year
- Having filled out the informed consent form
Key exclusion criteria (3 listed)
- Having a history of psychological and mental illness
- Having another illness with symptoms that may overlap with FAI symptoms
- Refusing to participate in the study
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 |
|---|---|---|
| Physical examination tests and surveysPatients'hip joint range of motion range of motion, pain levels, pressure-pain threshold levels, kinesiophobia levels, and hip dysfunction levels will be measured, and the alpha angle will be evaluated on hip radiographs. | Other | Clinical parameter assessment group |
Primary outcome
Tampa Kinesiophobia Scale
Time frame: One day (The assessments will be conducted once)
The scale is a questionnaire consisting of 17 questions applicable to musculoskeletal disorders, encompassing parameters related to work-associated activities, injury/reinjury, and fear-avoidance. The scale employs a 4-point Likert rating, where 1= Strongly Disagree and 4= Strongly Agree. After reversing the scoring of items 4, 8, 12, and 16, a total score is derived. The scale yields a total score ranging from 17 to 68. A high score on the scale indicates a high level of kinesiophobia.
4 secondary outcomes
Visual Analog Scale (VAS)
Time frame: One day (The assessments will be conducted once)
Pressure-pain Threshold Levels
Time frame: One day (The assessments will be conducted once)
Harris Hip Score
Time frame: One day (The assessments will be conducted once)
30 Second Sit to Stand Test
Time frame: One day (The assessments will be conducted once)
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 3 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Gulay Aras Bayram, Assist.Prof. study director
Istanbul Medipol University School of Health Science
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 Femoro Acetabular Impingement, run by Istanbul Medipol University Hospital 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 3 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 3 Aug 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. 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?
Tampa Kinesiophobia Scale (time frame: One day (The assessments will be conducted once)). 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 3 Aug 2025.