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Completed

NCT Number: NCT04435860

Muscle Strength Evaluations in Ankylosing Spondylitis

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

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Bezmialem University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
  • Being male
  • Aged ≥18

Exclusion criteria

  • Severe cardiac or pulmonary or renal disease
  • Accompanying fibromyalgia
  • Severe psychiatric disorder
  • Other disease limiting spinal, shoulder or hip range of motion
  • Myopathy, neuropathy or radiculopathy that may cause muscle weakness
  • Using high dose steroids
  • Endocrinological disorders
  • Malignancy
  • Pregnancy

Treatment and study plan

Truncal flexion-extension muscle power

Other

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

Truncal extension muscle power

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

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

Other

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

Cervical lateral flexion muscle powers

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

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

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

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

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

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

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

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

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

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

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)

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)

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)

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)

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

Primary outcomes

  1. Cervical muscle powers

    Time frame: 1 day

    Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.

  2. Truncal muscle powers

    Time frame: 1 day

    Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.

  3. Shoulder girdle muscle powers

    Time frame: 1 day

    Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.

  4. Hip girdle muscle powers

    Time frame: 1 day

    Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

Evaluation of Relationship Between Trunk, Proximal Girdle Muscles' Strength, and Functionality and Disease Activity in Male Patients With Ankylosing Spondylitis

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2020
Registry last updated
Sep 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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