NCT06198829

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

February 6, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 3, 2025

Status Verified

February 1, 2024

Enrollment Period

4 months

First QC Date

December 28, 2023

Last Update Submit

July 30, 2025

Conditions

Keywords

PainKinesiophobiaWeight-BearingFemoracetabular Impingement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Visual Analog Scale (VAS)

    One day (The assessments will be conducted once)

  • Pressure-pain Threshold Levels

    One day (The assessments will be conducted once)

  • Harris Hip Score

    One day (The assessments will be conducted once)

  • 30 Second Sit to Stand Test

    One day (The assessments will be conducted once)

Other Outcomes (2)

  • Weight-Bearing Asymmetry

    One day (The assessments will be conducted once)

  • Range of Motion

    One day (The assessments will be conducted once)

Study Arms (1)

Clinical parameter assessment group

Various assessments will be conducted on patients with femoroacetabular cam impingement.

Other: Physical examination tests and surveys

Interventions

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.

Clinical parameter assessment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Atasehir Hospital

Istanbul, Atasehir, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Femoracetabular ImpingementPainKinesiophobia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Gulay Aras Bayram, Assist.Prof.

    Istanbul Medipol University School of Health Science

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 10, 2024

Study Start

February 6, 2024

Primary Completion

June 10, 2024

Study Completion

December 30, 2024

Last Updated

August 3, 2025

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations