Evaluation of the Clinical Parameters and Kinesiophobia in Femoroacetabular Impingement Syndrome

Femoro Acetabular Impingement Clinical Trial

Official title:

The Evaluation of the Relationship Between Clinical Parameters and Kinesiophobia in Patients With Femoroacetabular Impingement Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06198829
• Other study ID #: ACU-FTR-YK-01
• Status: Recruiting
• Start date: February 6, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: February 2024
• Source: Istanbul Medipol University Hospital
• Contact: Yagmur Kucuk, B.Sc
• Phone: +905433927630
• Email: yagmur.kucuk[@]acibadem.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 in patients with FAIS.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoro Acetabular Impingement
• Kinesiophobia

Intervention

Other:
• Physical examination tests and surveys
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.

Locations

Country	Name	City	State
Turkey	Acibadem Atasehir Hospital	Istanbul	Atasehir

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight-Bearing Asymmetry	Two scales will be used for the assessment. Each participant's total body weight in kilograms will be recorded by having them step onto one of the scales. The scales will be used sequentially and alternately for each participant. After learning the weight of the participants, they will be placed 2 meters away from the wall with a 10 cm gap between their feet, and they will be asked to look straight ahead with one foot on each scale in an erect position. Three trials will be conducted, and the participants will be taken off the scale between trials. The average of the three measurements for each scale will be calculated, and the percentage of weight-bearing asymmetry will be determined using the following formula : Weight-Bearing Asymmetry Percentage = [(Load on the unaffected foot - Load on the affected foot) / Total body weight] × 100	One day (The assessments will be conducted once)
Other	Range of Motion	The patient's hip joint range of motion will be measured using a mobile application (Clinometer, plaincode app development and tech blog, Stephanskirchen, Germany). Wheyte et al. found that the application has excellent reliability in assessing hip extension and rotation values. The measurement will be repeated three times, and the average will be considered. For hip extension, the patient will progress from a seated position to the Modified Thomas Test position, while for internal and external rotation, the measurement will be taken with the patient in a seated position, legs hanging at 90 degrees flexion, and fixed above the knee. Measurements will be taken from the neutral position towards the direction of rotation.	One day (The assessments will be conducted once)
Primary	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.	One day (The assessments will be conducted once)
Secondary	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	One day (The assessments will be conducted once)
Secondary	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.	One day (The assessments will be conducted once)
Secondary	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.	One day (The assessments will be conducted once)
Secondary	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.	One day (The assessments will be conducted once)