The Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables

NCT05589922 | Completed

• 1 other identifier: MustafaKU07
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; Spinal mobility; Kinesiophobia; Balance

Outcome Measures

Primary Outcomes (6)

• Modified Schober Index

  The measurement of the MSI starts with the subject in an upright posture. After being determined the posterior superior iliac spines, a horizontal line is drawn at the center of both posterior superior iliac spines. Ten cm above and five cm below the first line are marked. The distance between the top and bottom line is remeasured after the patient attempts to flex forward as far as possible while keeping the knees straight

  at baseline

• Bath AS Metrology Index (BASMI)

  The BASMI is evulated quantify the mobility of the axial skeleton and includes assessments of lateral lumbar flexion, tragus-to-wall distance, lumbar flexion, intermalleolar distance, and cervical rotation. Each measure is assigned a score of 0 to 2 with the higher score indicating greater impairment in mobility

  at baseline

• Timed up and go test

  It aims to assess mobility and balance. It measures the time in seconds for a subject to stand up from an armchair, walk 3 m, turn, walk back to the chair, and sit down

  at baseline

• tandem stance test

  For the tandem stance test, patients stand holding onto a railing while placing one foot in front of the other. The researcher standing behind the patient starts timing when the patient's contact with the railing is released. It is recorded for 30 seconds or until participants contact external support or move out of tandem stance

  At baseline

• Falls Efficacy Scale-International

  The FES-I consists of 16 questions questioning how confident patients are in performing activities without falling. According to the answers, each question is scored between 1 and 4 (1 = not at all concerned, 4 = very concerned), and a higher score is associated with a greater fear of falling

  At baseline

• Tampa Scale for Kinesiophobia

  The TSK contains 17 questions which measures fear of movement and/or reinjury. The scale uses 4-point Likert scoring (1 = entirely disagree, 4 = entirely agree). A total score ranges from 11 to 44 points and a cut-off point was determined as ≥37 points indicate a high kinesiophobia level

  At baseline

Secondary Outcomes (5)

• functional reach test

  At baseline

• 30-second chair sit-to-stand test

  At baseline

• single leg stance test

  At baseline

• finger-to-floor distance measure

  At baseline

• Visual Analogue Scale

  At baseline

Study Arms (2)

Patients with abnormal modified Schober index

This group will include the patients with Ankylosing Spondylitis who have modified Schober index smaller than 5 cm

Patients with normal modified Schober index

This group will include the patients with Ankylosing Spondylitis who have modified Schober index bigger than 5 cm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Ankylosing Spondylitis

You may qualify if:

• Participants who meet the modified New York criteria for AS
• Participants over 18 years

You may not qualify if:

• Participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.),
• Participants with cognitive or psychiatric disorders,
• Participants with neuromuscular or orthopedic diseases

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation

Hatay, Alahan, 31060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing; Kinesiophobia

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: October 24, 2022
• Primary Completion: November 18, 2022
• Study Completion: January 30, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Locations

TU (1)