Clinical trial NCT06967883: Ultrasound Assessment of Neck Muscles and Balance in Male Patients With Ankylosing Spondylitis
Official title: The Relationship Between Ultrasonographic Measurements of Cervical Multifidus and Longus Colli Muscles and Balance in Male Patients With Ankylosing Spondylitis:Controlled Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankylosing Spondylitis
Balance Assessment
Balance
Spondylarthropathies; Spondylitis, Ankylosing
Keywords: ankylosing spondylitis
balance
deep cervical muscles
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-13
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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)

Detailed description: This study aims to investigate the relationship between cervical multifdus and longus Colli muscles and balance function in male patients diagnosed with Ankylosing Spondylitis (AS) according to the Modified New York Criteria. A total of 38 AS patients under regular follow-up at the Istanbul Physical Medicine and Rehabilitation Training and Research Hospital Rheumatology Clinic, along with 38 age-matched healthy male volunteers, will be included.

Ultrasonographic Imaging will be performed to assess the thickness and of the cervical multifidus and longus colli muscles.The HUR SmartBalance BTG4 (HUR-Labs Oy, Kokkola, Finland) balance platform will be used to measure postural sway, weight distribution, and the limit of stability (LOS) through a computerized system.The Berg Balance Scale (BBS), The Timed Up and Go (TUG) test,The Single-Leg Stance Test will be conducted, measuring the ability to maintain posture while standing on one leg. Disease Activity and Functional Assessment in AS Patients will be conducted by using The Bath Ankylosing Spondylitis Functional Index (BASFI), The Bath Ankylosing Spondylitis Metrology Index (BASMI) Additionally, the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) will be used to measure disease activity and quality of life will be assessed with Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).Cervical Muscle Strength Measurement will be performed using a hand-held dynamometer, which will objectively assess isometric cervical flexion and extension strength.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Mean Bilateral Thickness of Cervical Multifidus Muscle Assessed by Ultrasonography
timeFrame: baseline
measure: Mean Bilateral Thickness of Cervical Longus Colli Muscle Assessed by Ultrasonography
timeFrame: baseline
measure: Limits of Stability (LOS) Test
timeFrame: baseline
Secondary outcomes:
measure: Sway Area on Balance Platform
timeFrame: baseline
measure: Romberg Quotient
timeFrame: baseline
measure: Trace Length on Balance Platform
timeFrame: baseline
measure: Medio-Lateral (ML) Sway Range
timeFrame: baseline
measure: Anterior-Posterior (AP) Sway Range
timeFrame: baseline
measure: Average Sway Velocity
timeFrame: baseline
measure: Timed Up and Go (TUG) Test Duration
timeFrame: baseline
measure: Berg Balance Scale Total Score
timeFrame: baseline
Other outcomes:
measure: Isometric Cervical Flexion and Extension Strength Measured by Hand-Held Dynamometer
timeFrame: baseline
measure: Short Version of the Activities-Specific Balance Confidence Scale (ABC-6) Score
timeFrame: baseline
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Physical Medicine and Rehabilitation Trainig and Research Hospital
state: Bahcelievler
Study officials:
affiliation: Istanbul Physical Medicine and Rehabilitation Training Research Hospital
name: Nurdan Paker, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.