Muscle Strength Evaluations in Ankylosing Spondylitis

Ankylosing Spondylitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04435860
• Other study ID #: 2019-08/115
• Status: Completed
• Start date: June 18, 2020
• Est. completion date: September 4, 2020

Study information

• Verified date: September 2020
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Truncal flexion-extension muscle power
Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
• 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.
• 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.
• Cervical extension muscle power
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

Locations

Country	Name	City	State
Turkey	Bezmialem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical muscle powers	Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.	1 day
Primary	Truncal muscle powers	Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.	1 day
Primary	Shoulder girdle muscle powers	Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.	1 day
Primary	Hip girdle muscle powers	Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.	1 day