Ultrasound Assessment of Neck Muscles and Balance in Male Patients With Ankylosing Spondylitis

NCT06967883 | Recruiting

• 1 other identifier: ISTPMRTRH2024-80
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the relationship between ultrasonographic measurements of the cervical muscles and balance parameters in patients diagnosed with ankylosing spondylitis (AS)

Conditions

Ankylosing Spondylitis; Balance Assessment; Balance; Spondylarthropathies; Spondylitis, Ankylosing

Keywords

ankylosing spondylitis; balance; deep cervical muscles

Outcome Measures

Primary Outcomes (3)

• Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography

  Bilateral measurement of cervical multifidus muscle thickness using musculoskeletal ultrasound imaging. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.

  baseline

• Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography

  Bilateral measurement of cervical longus colli muscle thickness using musculoskeletal ultrasound imaging. Results will be reported in millimeters (mm). Data will be summarized as mean ± standard deviation.

  baseline

• Limits of Stability (LOS) Test

  The Limits of Stability (LOS) test will be conducted using the HUR SmartBalance platform. Participants will be asked to lean maximally forward, backward, to the right, and to the left, each for a duration of 8 s without lifting the sole and heel of the foot or correcting their feet. Using these methods, the individual's stability limits will be tested in four directions. The LOS score quantifies the subject's ability to voluntarily control posture within their stability limits. The leaning angle is based on the person's height and how far the center of pressure move from the normal position. A lower LOS score indicates impaired postural control and balance performance.

  baseline

Secondary Outcomes (8)

• Sway Area on Balance Platform

  baseline

• Romberg Quotient

  baseline

• Trace Length on Balance Platform

  baseline

• Medio-Lateral (ML) Sway Range

  baseline

• Anterior-Posterior (AP) Sway Range

  baseline

Other Outcomes (2)

• Isometric Cervical Flexion and Extension Strength Measured by Hand-Held Dynamometer

  baseline

• Short Version of the Activities-Specific Balance Confidence Scale (ABC-6) Score

  baseline

Study Arms (2)

Ankylosing Spondylitis Group

Male patients aged 18-65 years diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria, under regular follow-up at Istanbul Physical Medicine and Rehabilitation Rheumatology Clinic.

Diagnostic Test: Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension Strength

Control Group

Age-matched healthy male volunteers aged 18-65 years with cognitive ability sufficient to understand test instructions.

Diagnostic Test: Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension Strength

Interventions

Ultrasonographic assessment of Cervical Multifidus and Longus Colli Muscle Thickness, Postural Balance and Limit of Stability using the balance platform,Cervical Flexion and Extension Strength DIAGNOSTIC_TEST

Intervention Description Participants in both groups will undergo ultrasonographic measurement of cervical multifidus and longus colli muscle thickness. Postural sway, Limits of Stability (LOS), and a 6-direction balance test (ABC-6) will be assessed using the HUR SmartBalance BTG4 platform under stable and unstable conditions with eyes open and closed. Functional balance will be evaluated with the Berg Balance Scale (BBS), Timed Up and Go (TUG) Test, and Single-Leg Stance Test. Isometric cervical flexion and extension strength will be measured bilaterally using a hand-held dynamometer. Ankylosing Spondylitis patients will additionally complete BASFI, BASMI, BASDAI, and ASQoL questionnaires.

Ankylosing Spondylitis Group; Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from the Istanbul Physical Medicine and Rehabilitation Rheumatology Clinic, where they are under regular follow-up for Ankylosing Spondylitis (AS). The healthy control group will consist of hospital employees who meet the inclusion criteria and have no history of AS or other musculoskeletal disorders

You may qualify if:

• Age between 18 and 65 years.
• Diagnosed with Ankylosing Spondylitis according to the Modified New York Criteria (for patient group).
• Cognitive ability sufficient to understand and follow test instructions.

You may not qualify if:

• Orthopedic disorders affecting the spine or lower limbs.
• Cardiovascular disorders.
• Neurological disorders.
• Visual or auditory impairments.
• History of surgery involving the spine or lower limbs.
• Psychiatric disorders.
• Cognitive impairment.
• Clinical signs or symptoms of cervical radiculopathy.

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital

Istanbul, Bahcelievler, 34100, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• Ozen T, Tonga E, Polat MG, Bayraktar D, Akar S. Cervical proprioception accuracy is impaired in patients with axial spondyloarthritis. Musculoskelet Sci Pract. 2021 Feb;51:102304. doi: 10.1016/j.msksp.2020.102304. Epub 2020 Nov 16.

  PMID: 33227676 BACKGROUND

• Turk E, Yurdakul FG, Guler T, Bodur H. Posture, balance and gait in axial spondyloarthritis: a case-control study. Rheumatol Int. 2024 Nov;44(11):2527-2538. doi: 10.1007/s00296-024-05710-5. Epub 2024 Sep 4.

  PMID: 39230687 BACKGROUND

Related Links

• Sonographic Comparison of Neck Extensor Muscle Thickness of Ankylosing Spondylitis and Non-radiographic Axial Spondyloarthritis Patients with Healthy Volunteers

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylarthropathies; Spondylitis

Interventions

Postural Balance

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthritis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Bone Diseases, Infectious; Infections

Intervention Hierarchy (Ancestors)

Proprioception; Vestibulocochlear Physiological Phenomena; Physiological Phenomena; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Sensation; Nervous System Physiological Phenomena

Study Officials

• Nurdan Paker, MD, Prof.

  Istanbul Physical Medicine and Rehabilitation Training Research Hospital

  STUDY DIRECTOR

Central Study Contacts

Ecem Cetin Atakan, MD

CONTACT

90+5353440933; ecemcetin1995@hotmail.com

Nurdan Paker, MD,Prof.

CONTACT

90+5326917591; nurdanpaker@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: May 13, 2025
• Study Start: January 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)