Muscle Strength Evaluations in Ankylosing Spondylitis

Completed

• Conditions: Ankylosing Spondylitis
• Interventions: Other: Truncal flexion-extension muscle power; Other: Truncal extension muscle power; Other: Cervical flexion muscle power; Other: Cervical extension muscle power; Other: Cervical lateral flexion muscle powers; Other: Shoulder flexion muscle power; Other: Shoulder extension muscle power; Other: Shoulder internal rotation muscle power; Other: Shoulder external rotation muscle power; Other: Shoulder abduction muscle power; Other: Hip flexion muscle power; Other: Hip extension muscle power; Other: Hip abduction muscle power; Other: Hip internal rotation muscle power; Other: Hip external rotation muscle power; Other: Bath Ankylosing Spondylitis Functional Index (BASFI); Other: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); Other: The Health assessment questionnaire (HAQ); Other: Bath Ankylosing Spondylitis Metrology Index (BASMI)

• Registration Number: NCT04435860
• Lead Sponsor: Bezmialem Vakif University

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.

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-16
• Study First Posted: 2020-06-17
• Study Start: 2020-06-18
• Status Verified: 2020-09
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	Cervical lateral flexion muscle powers	Healthy individuals meeting the exclusion criteria
Ankylosing Spondylitis	Shoulder abduction muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Truncal extension muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Cervical lateral flexion muscle powers	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Shoulder internal rotation muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Hip abduction muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	The Health assessment questionnaire (HAQ)	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Healthy Controls	Cervical flexion muscle power	Healthy individuals meeting the exclusion criteria
Ankylosing Spondylitis	Truncal flexion-extension muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Shoulder external rotation muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Bath Ankylosing Spondylitis Functional Index (BASFI)	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Bath Ankylosing Spondylitis Metrology Index (BASMI)	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Healthy Controls	Truncal extension muscle power	Healthy individuals meeting the exclusion criteria
Ankylosing Spondylitis	Cervical flexion muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Shoulder extension muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Hip flexion muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Hip internal rotation muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Healthy Controls	Truncal flexion-extension muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Shoulder abduction muscle power	Healthy individuals meeting the exclusion criteria
Ankylosing Spondylitis	Hip external rotation muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Healthy Controls	Hip abduction muscle power	Healthy individuals meeting the exclusion criteria
Ankylosing Spondylitis	Cervical extension muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Shoulder flexion muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Hip extension muscle power	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Ankylosing Spondylitis	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria
Healthy Controls	Cervical extension muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Shoulder internal rotation muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Hip external rotation muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Shoulder flexion muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Shoulder extension muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Shoulder external rotation muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Hip flexion muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Hip extension muscle power	Healthy individuals meeting the exclusion criteria
Healthy Controls	Hip internal rotation muscle power	Healthy individuals meeting the exclusion criteria

Primary Outcome Measures

Name	Time	Method
Cervical muscle powers	1 day	Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.
Shoulder girdle muscle powers	1 day	Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
Truncal muscle powers	1 day	Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.
Hip girdle muscle powers	1 day	Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.

Trial Locations

Locations (1)

Bezmialem University; 🇹🇷 Istanbul, Turkey