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Clinical Trials/NCT05589922
NCT05589922
Completed
Not Applicable

Determining the Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables in Patients With Ankylosing Spondylitis

Mustafa Kemal University1 site in 1 country100 target enrollmentOctober 24, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ankylosing Spondylitis
Sponsor
Mustafa Kemal University
Enrollment
100
Locations
1
Primary Endpoint
tandem stance test
Status
Completed
Last Updated
2 years ago

Overview

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

Detailed Description

Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). Inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with AS (2). It is unknown how these parameters of AS participants with AMSI (smaller than 5 cm) are affected compared to AS participants with normal modified Schober index (NMSI, bigger than 5 cm). In addition, it is unclear which demographic characteristics and variables predispose AMSI to occur. This study will aim to compare 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

Registry
clinicaltrials.gov
Start Date
October 24, 2022
End Date
January 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Gamze Kus

assistant professor

Mustafa Kemal University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

tandem stance test

Time Frame: At baseline

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

Timed up and go test

Time Frame: at baseline

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

Falls Efficacy Scale-International

Time Frame: At baseline

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

Tampa Scale for Kinesiophobia

Time Frame: At baseline

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

Modified Schober Index

Time Frame: at baseline

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

Bath AS Metrology Index (BASMI)

Time Frame: at baseline

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

Secondary Outcomes

  • 30-second chair sit-to-stand test(At baseline)
  • functional reach test(At baseline)
  • finger-to-floor distance measure(At baseline)
  • single leg stance test(At baseline)
  • Visual Analogue Scale(At baseline)

Study Sites (1)

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