Clinical trial NCT04435860: Muscle Strength Evaluations in Ankylosing Spondylitis
Official title: Evaluation of Relationship Between Trunk, Proximal Girdle Muscles' Strength, and Functionality and Disease Activity in Male Patients With Ankylosing Spondylitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Muscle Powers
Functionality
Disease Activity
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Controls: Healthy volunteers meeting inclusion criteria accepting to participate Ankylosing spondylitis group: Ankylosing spondylitis patients meeting inclusion criteria accepting to participate

Brief summary: This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls.

Detailed description: Ankylosing spondylitis is a chronic, inflammatory rheumatic disease with an unclear etiology which causes back pain and affects the functionality of axial skeleton. Besides the effect upon axial skeleton, the disease also affects the peripheral joints. In most patients, tenuous affection of peripheral joints occurs however, in some others the disease causes impaired spinal mobility and articular instability. This causes proximal girdle muscles and trunk muscles of the patients to be exposed to excessively stress and in conclusion deformities develop. Maximum force generated by a muscle or muscle group directly effects the physical ability of an individual, and manual muscle dynamometers are used to directly evaluate the muscle strength. In this manner the investigators aim to evaluate trunk and proximal girdle muscles' powers in male patients with ankylosing spondylitis and analyze the correlation between muscle powers, and functionality and disease activity.

Eligibility criteria: Inclusion Criteria:

1. Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
2. Being male
3. Aged ≥18

Exclusion Criteria:

1. Severe cardiac or pulmonary or renal disease
2. Accompanying fibromyalgia
3. Severe psychiatric disorder
4. Other disease limiting spinal, shoulder or hip range of motion
5. Myopathy, neuropathy or radiculopathy that may cause muscle weakness
6. Using high dose steroids
7. Endocrinological disorders
8. Malignancy
9. Pregnancy

Primary outcomes:
measure: Cervical muscle powers
timeFrame: 1 day
measure: Truncal muscle powers
timeFrame: 1 day
measure: Shoulder girdle muscle powers
timeFrame: 1 day
measure: Hip girdle muscle powers
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem University
Study officials:
affiliation: Bezmialem University
name: Ozan Volkan Yurdakul, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SC, Lee YG, Park SB, Kim TH, Lee KH. Muscle Mass, Strength, Mobility, Quality of Life, and Disease Severity in Ankylosing Spondylitis Patients: A Preliminary Study. Ann Rehabil Med. 2017 Dec;41(6):990-997. doi: 10.5535/arm.2017.41.6.990. Epub 2017 Dec 28.
citation: Daloia LMT, Leonardi-Figueiredo MM, Martinez EZ, Mattiello-Sverzut AC. Isometric muscle strength in children and adolescents using Handheld dynamometry: reliability and normative data for the Brazilian population. Braz J Phys Ther. 2018 Nov-Dec;22(6):474-483. doi: 10.1016/j.bjpt.2018.04.006. Epub 2018 May 4.
citation: De Blaiser C, De Ridder R, Willems T, Danneels L, Roosen P. Reliability and validity of trunk flexor and trunk extensor strength measurements using handheld dynamometry in a healthy athletic population. Phys Ther Sport. 2018 Nov;34:180-186. doi: 10.1016/j.ptsp.2018.10.005. Epub 2018 Oct 12.
citation: Yurdakul OV, Ince OE, Bagcier F, Kara M, Kultur E, Aydin T. Evaluating the strength of spinal and proximal girdle muscles in patients with axial spondyloarthritis: Correlation with activity, disability, and functionality. Int J Rheum Dis. 2021 May;24(5):701-710. doi: 10.1111/1756-185X.14102. Epub 2021 Mar 22.