Muscle Strength Evaluations in Ankylosing Spondylitis

NCT ID: NCT04435860

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-18

Study Completion Date

2020-09-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankylosing Spondylitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ankylosing Spondylitis

Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria

Truncal flexion-extension muscle power

Intervention Type OTHER

Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,

Truncal extension muscle power

Intervention Type OTHER

Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.

Cervical flexion muscle power

Intervention Type OTHER

Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.

Cervical extension muscle power

Intervention Type OTHER

Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.

Cervical lateral flexion muscle powers

Intervention Type OTHER

Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.

Shoulder flexion muscle power

Intervention Type OTHER

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.

Shoulder extension muscle power

Intervention Type OTHER

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.

Shoulder internal rotation muscle power

Intervention Type OTHER

Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.

Shoulder external rotation muscle power

Intervention Type OTHER

Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.

Shoulder abduction muscle power

Intervention Type OTHER

Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.

Hip flexion muscle power

Intervention Type OTHER

Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.

Hip extension muscle power

Intervention Type OTHER

Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.

Hip abduction muscle power

Intervention Type OTHER

Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.

Hip internal rotation muscle power

Intervention Type OTHER

Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.

Hip external rotation muscle power

Intervention Type OTHER

Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.

Bath Ankylosing Spondylitis Functional Index (BASFI)

Intervention Type OTHER

This questionnaire evaluates the functionality in patients with AS. The ten questions that comprise the BASFI were chosen with input from patients with AS. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test. The final score varies between 0 and 10.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Intervention Type OTHER

This questionnaire evaluates the disease activity level in patients with AS. The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS. The final score varies between 0 and 10.

The Health assessment questionnaire (HAQ)

Intervention Type OTHER

The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual. The patients report the amount of difficulty they have in performing eight daily living activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The final score varies between 0 and 3.

Bath Ankylosing Spondylitis Metrology Index (BASMI)

Intervention Type OTHER

Bath Ankylosing Spondylitis Metrology Index, a combined index to assess the spinal mobility. It evaluates the patients regarding cervical rotation, tragus-to-wall distance, lumbar flexion, lumbar lateral flexion and intermalleolar distance. The total score varies between 5 to 15 in patients with ankylosing spondylitis

Healthy Controls

Healthy individuals meeting the exclusion criteria

Truncal flexion-extension muscle power

Intervention Type OTHER

Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,

Truncal extension muscle power

Intervention Type OTHER

Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.

Cervical flexion muscle power

Intervention Type OTHER

Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.

Cervical extension muscle power

Intervention Type OTHER

Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.

Cervical lateral flexion muscle powers

Intervention Type OTHER

Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.

Shoulder flexion muscle power

Intervention Type OTHER

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.

Shoulder extension muscle power

Intervention Type OTHER

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.

Shoulder internal rotation muscle power

Intervention Type OTHER

Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.

Shoulder external rotation muscle power

Intervention Type OTHER

Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.

Shoulder abduction muscle power

Intervention Type OTHER

Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.

Hip flexion muscle power

Intervention Type OTHER

Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.

Hip extension muscle power

Intervention Type OTHER

Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.

Hip abduction muscle power

Intervention Type OTHER

Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.

Hip internal rotation muscle power

Intervention Type OTHER

Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.

Hip external rotation muscle power

Intervention Type OTHER

Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Truncal flexion-extension muscle power

Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,

Intervention Type OTHER

Truncal extension muscle power

Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.

Intervention Type OTHER

Cervical flexion muscle power

Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.

Intervention Type OTHER

Cervical extension muscle power

Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.

Intervention Type OTHER

Cervical lateral flexion muscle powers

Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.

Intervention Type OTHER

Shoulder flexion muscle power

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.

Intervention Type OTHER

Shoulder extension muscle power

Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.

Intervention Type OTHER

Shoulder internal rotation muscle power

Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.

Intervention Type OTHER

Shoulder external rotation muscle power

Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.

Intervention Type OTHER

Shoulder abduction muscle power

Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.

Intervention Type OTHER

Hip flexion muscle power

Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.

Intervention Type OTHER

Hip extension muscle power

Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.

Intervention Type OTHER

Hip abduction muscle power

Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.

Intervention Type OTHER

Hip internal rotation muscle power

Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.

Intervention Type OTHER

Hip external rotation muscle power

Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.

Intervention Type OTHER

Bath Ankylosing Spondylitis Functional Index (BASFI)

This questionnaire evaluates the functionality in patients with AS. The ten questions that comprise the BASFI were chosen with input from patients with AS. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being "easy" and 10 "impossible) is used to answer the questions on the test. The final score varies between 0 and 10.

Intervention Type OTHER

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

This questionnaire evaluates the disease activity level in patients with AS. The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS. The final score varies between 0 and 10.

Intervention Type OTHER

The Health assessment questionnaire (HAQ)

The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual. The patients report the amount of difficulty they have in performing eight daily living activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The final score varies between 0 and 3.

Intervention Type OTHER

Bath Ankylosing Spondylitis Metrology Index (BASMI)

Bath Ankylosing Spondylitis Metrology Index, a combined index to assess the spinal mobility. It evaluates the patients regarding cervical rotation, tragus-to-wall distance, lumbar flexion, lumbar lateral flexion and intermalleolar distance. The total score varies between 5 to 15 in patients with ankylosing spondylitis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bezmialem Vakif University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ozan Volkan Yurdakul, Assoc Prof

Role: PRINCIPAL_INVESTIGATOR

Bezmialem University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Bezmialem University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 29354575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29802034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30366246 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33750032 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-08/115

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.