Ankylosing SpondylitisNCT04435860
Muscle Strength Evaluations in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Truncal flexion-extension muscle power, Truncal extension muscle power and Cervical flexion muscle power
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jun 2020to 4 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Controls: Healthy volunteers meeting inclusion criteria accepting to participate Ankylosing spondylitis group: Ankylosing spondylitis patients meeting inclusion criteria accepting to participate
Who may be able to join
- Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
- Being male
- Aged ≥18
Who cannot join
- 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
Show all 9Show fewer
- Endocrinological disorders
- Malignancy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Relationship Between Trunk, Proximal Girdle Muscles' Strength, and Functionality and Disease Activity in Male Patients With Ankylosing Spondylitis
This study evaluates how the trunk and proximal girdle muscles are affected in male patients with ankylosing spondylitis, compared to healthy controls.
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Truncal flexion-extension muscle power, Truncal extension muscle power, Cervical flexion muscle power, Cervical extension muscle power, Cervical lateral flexion muscle powers
- Keywords
- Muscle Powers, Functionality, Disease Activity
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truncal flexion-extension muscle powerOther
Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
Truncal extension muscle powerOther
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 powerOther
Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
Cervical extension muscle powerOther
Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
Cervical lateral flexion muscle powersOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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 powerOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis | Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria Receives: 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) | |
| Healthy Controls | Healthy individuals meeting the exclusion criteria Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical muscle powers
Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.
Measured: 1 day
Truncal muscle powers
Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.
Measured: 1 day
Shoulder girdle muscle powers
Shoulder flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
Measured: 1 day
Hip girdle muscle powers
Hip flexion, extension, abduction, internal rotation, and external rotation muscle powers in kilograms as assessed with handheld dynamometer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start18 Jun 2020
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozan Volkan Yurdakul, Assoc Prof, Principal investigator, Bezmialem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435860
- Sponsor's protocol ID
- 2019-08/115
- Status last verified
- Sep 2020
- First submitted
- 15 Jun 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29354575Daloia 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.
PubMed 29802034De 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.
PubMed 30366246Yurdakul 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.
PubMed 33750032
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Relationship Between Trunk, Proximal Girdle Muscles' Strength, and Functionality and Disease Activity in Male Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04435860
- Acronym / sponsor ID
- 2019-08/115
- Conditions
- Ankylosing Spondylitis
- Keywords
- Muscle Powers, Functionality, Disease Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis | – | 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)Patients with ankylosing spondylitis meeting the inclusion and exclusion criteria |
| Healthy Controls | – | 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 powerHealthy individuals meeting the exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Controls: Healthy volunteers meeting inclusion criteria accepting to participate Ankylosing spondylitis group: Ankylosing spondylitis patients meeting inclusion criteria accepting to participate
Key inclusion criteria (3 listed)
- Having a diagnosis of ankylosing spondylitis according to Modified NewYork criteria
- Being male
- Aged ≥18
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Truncal flexion-extension muscle powerPatient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum, | Other | Ankylosing Spondylitis, Healthy Controls |
| Truncal extension muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Cervical flexion muscle powerPatient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead. | Other | Ankylosing Spondylitis, Healthy Controls |
| Cervical extension muscle powerPatient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis. | Other | Ankylosing Spondylitis, Healthy Controls |
| Cervical lateral flexion muscle powersPatient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion. | Other | Ankylosing Spondylitis, Healthy Controls |
| Shoulder flexion muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Shoulder extension muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Shoulder internal rotation muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Shoulder external rotation muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Shoulder abduction muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Hip flexion muscle powerPatient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh. | Other | Ankylosing Spondylitis, Healthy Controls |
| Hip extension muscle powerPatient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh. | Other | Ankylosing Spondylitis, Healthy Controls |
| Hip abduction muscle powerPatient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh. | Other | Ankylosing Spondylitis, Healthy Controls |
| Hip internal rotation muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| Hip external rotation muscle powerPatient 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. | Other | Ankylosing Spondylitis, Healthy Controls |
| 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. | Other | Ankylosing Spondylitis |
| 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. | Other | Ankylosing Spondylitis |
| 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. | Other | Ankylosing Spondylitis |
| 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 | Other | Ankylosing Spondylitis |
Primary outcome
Cervical muscle powers
Time frame: 1 day
Cervical flexion, extension, and lateral flexion muscle powers in kilograms as assessed with handheld dynamometer.
Truncal muscle powers
Time frame: 1 day
Truncal flexion and extension muscle powers in kilograms as assessed with handheld dynamometer.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Background: PubMed 29354575Kim 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.
- Background: PubMed 29802034Daloia 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.
- Background: PubMed 30366246De 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.
- Derived from this study: PubMed 33750032Yurdakul 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ozan Volkan Yurdakul, Assoc Prof principal investigator
Bezmialem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical muscle powers (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435860, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.