Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Spine Deformities in Juvenile Idiopathic Arthritis (Scoliosis)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664231
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : March 4, 2022
Sponsor:
Collaborator:
Istanbul University-Cerrahpasa
Information provided by (Responsible Party):
Eylül Pınar KISA, Biruni University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis.

Condition or disease
Scoliosis Juvenile Idiopathic Arthritis Awareness

Detailed Description:
Juvenile Idiopathic Arthritis (JIA)is the most common chronic rheumatic disease in childhood. While JIA usually affects the ankle and knee joints, it can also affect hip, cervical spine and shoulder involvement. Secondary problems such as spine involvement or lack of weight transfer may lead to scoliosis. The aim of this study was to perform scoliosis screening in children with JIA and to evaluate families' awareness of scoliosis. aged 4-16 years will include in the study. Trunk rotation measure with scoliometer by applying forward bending test. Children with more than 5 rotations will send to the X-ray. 28 questions will asked, which evaluate the demographic characteristics of children, their educational status, their participation in sports activities, and the physical appearance of families about their children. These questions will asked if the parents had heard of scoliosis before, where they heard it, and whether anyone had scoliosis in the family. Families who complained of posture disorder will asked which shoulder is high without looking at their children and whether they see any height when they leaned forward and the pain situation in their children. Statistical analysis of the data using the SPSS 24.0 (Statistical Package for Social Sciences) program. In all analyzes, p≤0.05 consider statistically significant.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 257 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Investigation of the Scoliosis of Children With Juvenile Idiopathic Arthritis and Awareness of the Parents Related to Scoliosis
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : May 15, 2021
Actual Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Children with JIA
Children with JIA coming to clinic
Healthy Children
Healthy Children in the school


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Assesment of angle of trunk rotation [ Time Frame: Baseline ]
    Angle of trunk rotation (ATR) will be evaluated with Scoliometer.It is an easy-to-use, reliable, practical specially designed inclinometer for scoliometer. The evaluation will be done with Adam's Bend test, in the standing forward bending position. Child's feet will be positioned parallel to each other. The physiotherapist who measures to adjust the distance between the feet, by placing one foot between the two feet of the child, by moving the scoliometer from the beginning of the thoracic to the sacrum, the largest measured angle of rotation will be recorded.

  2. Radiological imaging [ Time Frame: Baseline ]
    Radiological imaging shows vertebrae' lateral tilt degree. It calculated with Cobb angle method. The Cobb angle provides information about the degree of scoliosis.i It is accepted as a clinical evaluation method used in giving information about scoliosis and determining the effectiveness of treatment and prognosis of scoliosis.


Secondary Outcome Measures :
  1. Patient awareness forms [ Time Frame: Baseline ]
    It will be created to obtain sociodemographic information and personal data about the disease. In this context, gender, age, height, weight, occupation, educational status, dominant side, affected side (s) and patient history, disease duration, time spend at the desk and sports activity will be questioned in detail. For family Scoliosis Awareness, Have you heard of scoliosis?, Is there a family?, Are the child's shoulder heights equal? (Say without looking), Which one is high? When you bend forward, do you see an asymmetry on the back?, Is there any pain? questions will ask


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
children with juvenile idiopathic arthritis
Criteria

Inclusion Criteria:

  • Having been diagnosed with rheumatology age between 6-16,
  • to be diagnosed at least 6 months ago;
  • ability to walk independently; ability to read and write in Turkish; able to follow simple instructions
  • no pathology in visual ability and hearing

Exclusion Criteria:

  • a history of specific balance problems (i.e., diagnosed vestibular or neurological disorder);
  • severe musculoskeletal, neurological or cardiovascular disorders that limit mobility;
  • use of medication(s) such as sedatives and hypnotics, antidepressants and benzodiazepines
  • participate in scoliosis rehabilitation in the lasts 6-months.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664231


Locations
Layout table for location information
Turkey
Eylül Pınar Kısa
İ̇stanbul, Turkey, 34720
Sponsors and Collaborators
Biruni University
Istanbul University-Cerrahpasa
Investigators
Layout table for investigator information
Study Director: KISA Biruni University
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Eylül Pınar KISA, Lecturer, Biruni University
ClinicalTrials.gov Identifier: NCT04664231    
Other Study ID Numbers: Pre-PHD thesis
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: March 4, 2022
Last Verified: February 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eylül Pınar KISA, Biruni University:
scoliosis
Juvenile idiopathic arthritis
Awareness
spine
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Scoliosis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Spinal Curvatures
 Spinal Diseases
Bone Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases