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

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05589922
• Other study ID #: MustafaKU07
• Status: Completed
• Start date: October 24, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: June 2023
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2023
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation	Hatay	Alahan

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	functional reach test	For the functional reach test, the patient is asked to stand erect with feet separated from each other in a comfortable position and reach the farthest distance without touching the wall or without taking a step. The difference in the distance between the starting point and the endpoint is recorded in cm.	At baseline
Secondary	30-second chair sit-to-stand test	The proximal muscle strength and endurance of the lower extremities assessed by the 30-second chair sit-to-stand. The patients is seated in an armless chair with their back straight, arms crossed in front of the chest, and feet approximately a shoulder width apart and placed on the floor. Then patients are instructed to fully sit between each stand.	At baseline
Secondary	single leg stance test	For the SLST is performed by standing on one leg (eyes open) barefoot for 20 seconds, the other knee flexed without touching the other leg, with arms are crossed. The test will be repeated thrice on each foot, and the average time will be used for analysis.	At baseline
Secondary	finger-to-floor distance measure	For finger-to-floor distance (FFD), the subject is asked to perform maximal lumbar flexion while keeping the knees extend. After which, the distance between the right middle finger and the floor is measured using a tape measure	At baseline
Secondary	Visual Analogue Scale	Pain scores of the patients at night, at rest, and during activity are measured using visual analogue scale (VAS). (0-10 mm; 0 indicates no pain and 10 indicates severe pain)	At baseline