Ankylosing SpondylitisNCT06226792
Muscle Architecture in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Muscle Weakness, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to determine whether there is a decrease in muscle mass and the relationship between lower extremity skeletal muscle mass, muscle strength and disease activity in Ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Ankylosing Spondylitis, Muscle Weakness, Rheumatic Diseases
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Jan 2024to 2 Mar 2024
- How long will I take part?
- 1 Day
- 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
- Adult, Older adult
Study population: Patients who applied to the Bezmialem Vakıf University, Physical Medicine and Rehabilitation Outpatient Clinic appropriate for eligibility criteria will be enrolled.
Who may be able to join
- Being ≥18 years old,
- Being diagnosed with AS according to The Assesment of Spondyloarthritis international society (ASAS) criteria
- Ability to giving consent
- Ability to live independently
- Ability to walk without assistive devices.
Who cannot join
- History of surgery on the spine or lower extremities,
- History of inflammatory rheumatic disease,
- Severe cardiovascular disease,
- Neuromuscular disease affecting muscle strength,
- Individuals following a regular exercise program,
- Secondary osteoarthritis.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University
Istanbul, Fatih, 34093
About this study
Official title: Muscle Architecture in Ankylosing Spondylitis and Its Relationship With Clinical Parameters
The goal of this observational study is to determine whether there is a decrease in muscle mass and the relationship between lower extremity skeletal muscle mass, muscle strength and disease activity in Ankylosing spondylitis.
The main questions it aims to answer are:
- Is there a relationship between the muscle thickness and pennation angle of the quadriceps, Gastrocnemius medialis and lateralis, Vastus medialis and lateralis and tibialis anterior muscles with disease activity and muscle strength?
- Are there any differences in the results of morphological parameters of lower extremity muscles between Ankylosing spondylitis and voluntary participants? Researchers will compare voluntary participants to see if any difference in lower muscle morphological parameters.
Read the detailed description
Ankylosing spondylitis (AS) Ankylosing spondylitis (AS) is a systemic inflammatory rheumatic disease that can cause characteristic inflammatory low back pain and structural and functional disorders by affecting the axial and peripheral skeleton.
Functional impairment increases with age, disease duration, and severity of symptoms. It has been shown that there is a significant relationship between dysfunction and activity limitation in AS patients.
Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis3. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. Given the risk of chronic inflammation and reduced physical activity, patients are also at risk of accelerated muscle wasting. In chronic diseases, loss of muscle mass, often referred to as cachexia, is a relevant systemic complication that leads to decreased muscle strength and endurance, reduced physical activity and fitness.
However, there is no study reporting variation in lower extremity information, muscle development, morphological effects measured by ultrasound, muscle strength and disease intensity in AS patients. Therefore, this study was conducted to determine whether there is a decrease in muscle according to the wide general spread in AS patients and to strengthen the detachable lower extremity structure with AS, muscle strength and possible presence. The relationship between strength, power and mobility of skeletal muscles was also evaluated. Although muscle loss was not morphologically evident in previous ultrasounds, it has not been investigated whether this leads to loss of muscle strength.
- Conditions
- Ankylosing Spondylitis, Muscle Weakness, Rheumatic Diseases
- Medical subject headings
- Spondylitis, Ankylosing, Muscle Weakness, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ankylosing Spondylitis | Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Rivermead Mobility Index (RMI) will be evaluated. Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer. | |
| Volunteers | Voluntary participants will be admitted to this group. Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
It evaluates disease-specific symptoms such as fatigue, spinal and peripheral joint pain, swelling and morning stiffness and is interpreted on a score ranging from 0 to 10. Each question is scored on a scale of 0 to 10. Aside from the last question, 0 indicates none and 10 indicate very severe. For the last question, 0 is 0 hours, 5 is one hour, and 10 is two or more hours.
To calculate the BASDAI score, the formula is:
BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Measured: 1 Day
Bath Ankylosing Spondylitis Functional Index (BASFI)
It is an index that is fast and easy to apply, sensitive to changes and reliable, developed for determining and monitoring the functional status of patients with AS. It consists of 10 questions that evaluate patients' abilities to bend, reach, stand, change positions, climb stairs, and cope with activities of daily living. For each question, the final score is obtained by dividing the total score by 10 using the visual analogue scale (VAS) in the range of 0-10 cm. A higher score indicates a higher degree of functional limitations.
Measured: 1 Day
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI consists of five clinical measurements: cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion, and intermalleolar distance. It was first developed as a two-point scale in 1994 and was later adapted to a 10-point score. The 10-point BASMI scale was used in our study.The higher the BASMI score the more severe the patient's limitation of movement due to their Ankylosing Spondylitis.
Measured: 1 Day
Rivermead Mobility Index
It is a one-dimensional index that focuses on measuring mobility status and includes basic mobility activities. It includes a series of hierarchical activities, from turning over in bed to running, consisting of 14 questions and one observation that fit the Guttman Scale. RMI was mainly developed for the purpose of evaluating the results of physiotherapy interventions after head trauma or stroke, and it is reported that it can be used in hospitals, outpatient clinics or home environments without requiring expertise. Self-reporting is essential in answering questions. Only the 5th item is observed and evaluated by the interviewer. 1 point is given for each "yes" answer and a range of 0-15 points can be received. A score of 15 points indicates that there is no problem in mobility, and a score of 14 points and below indicates that there is a mobility problem.
Measured: 1 Day
Isometric Knee Extension Muscle Strength
Isometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 Day
Isometric Ankle Dorsiflexion Muscle Strength
Isometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Measured: 1 Day
Isometric Ankle Plantar Flexion Muscle Strength
Isometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
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 posted26 Jan 2024
- Study start18 Jan 2024
- Primary completion1 Feb 2024
- Study completion2 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehmet Serkan Kılıçoğlu, Ass.Prof., Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226792
- Sponsor's protocol ID
- 2022/340
- Status last verified
- Mar 2024
- First submitted
- 18 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.
PubMed 23973125Walton JM, Roberts N, Whitehouse GH. Measurement of the quadriceps femoris muscle using magnetic resonance and ultrasound imaging. Br J Sports Med. 1997 Mar;31(1):59-64. doi: 10.1136/bjsm.31.1.59.
PubMed 9132215Blum D, Rodrigues R, Geremia JM, Brenol CV, Vaz MA, Xavier RM. Quadriceps muscle properties in rheumatoid arthritis: insights about muscle morphology, activation and functional capacity. Adv Rheumatol. 2020 May 19;60(1):28. doi: 10.1186/s42358-020-00132-w.
PubMed 32429993Aily JB, de Noronha M, de Almeida AC, Pedroso MG, Maciel JG, Mattiello-Sverzut AC, Mattiello SM. Evaluation of vastus lateralis architecture and strength of knee extensors in middle-aged and older individuals with knee osteoarthritis. Clin Rheumatol. 2019 Sep;38(9):2603-2611. doi: 10.1007/s10067-019-04539-9. Epub 2019 Apr 23.
PubMed 31016579Rastelli F, Capodaglio P, Orgiu S, Santovito C, Caramenti M, Cadioli M, Falini A, Rizzo G, Lafortuna CL. Effects of muscle composition and architecture on specific strength in obese older women. Exp Physiol. 2015 Oct;100(10):1159-67. doi: 10.1113/EP085273. Epub 2015 Sep 10.
PubMed 26279270van der Heijde D, Braun J, Deodhar A, Baraliakos X, Landewe R, Richards HB, Porter B, Readie A. Modified stoke ankylosing spondylitis spinal score as an outcome measure to assess the impact of treatment on structural progression in ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):388-400. doi: 10.1093/rheumatology/key128.
PubMed 29860356Wang CY, Olson SL, Protas EJ. Test-retest strength reliability: hand-held dynamometry in community-dwelling elderly fallers. Arch Phys Med Rehabil. 2002 Jun;83(6):811-5. doi: 10.1053/apmr.2002.32743.
PubMed 12048660Blazevich AJ, Cannavan D, Coleman DR, Horne S. Influence of concentric and eccentric resistance training on architectural adaptation in human quadriceps muscles. J Appl Physiol (1985). 2007 Nov;103(5):1565-75. doi: 10.1152/japplphysiol.00578.2007. Epub 2007 Aug 23.
PubMed 17717119
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Architecture in Ankylosing Spondylitis and Its Relationship With Clinical Parameters
- ClinicalTrials.gov ID
- NCT06226792
- Acronym / sponsor ID
- 2022/340
- Conditions
- Ankylosing Spondylitis, Muscle Weakness, Rheumatic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 2 Mar 2024 (actual)
- First posted
- 26 Jan 2024 (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.
The goal of this observational study is to determine whether there is a decrease in muscle mass and the relationship between lower extremity skeletal muscle mass, muscle strength and disease activity in Ankylosing spondylitis.
The main questions it aims to answer are:
- Is there a relationship between the muscle thickness and pennation angle of the quadriceps, Gastrocnemius medialis and lateralis, Vastus medialis and lateralis and tibialis anterior muscles with disease activity and muscle strength?
- Are there any differences in the results of morphological parameters of lower extremity muscles between Ankylosing spondylitis and voluntary participants? Researchers will compare voluntary participants to see if any difference in lower muscle morphological parameters.
Detailed description
Ankylosing spondylitis (AS) Ankylosing spondylitis (AS) is a systemic inflammatory rheumatic disease that can cause characteristic inflammatory low back pain and structural and functional disorders by affecting the axial and peripheral skeleton.
Functional impairment increases with age, disease duration, and severity of symptoms. It has been shown that there is a significant relationship between dysfunction and activity limitation in AS patients.
Recent studies have reported that both sarcopenia and decreased muscle strength occur in patients with chronic inflammatory diseases such as rheumatoid arthritis3. There are concerns that sarcopenia may affect exercise tolerance, activities of daily living, and ultimately have a negative impact on cardiovascular fitness and physical and emotional well-being. Given the risk of chronic inflammation and reduced physical activity, patients are also at risk of accelerated muscle wasting. In chronic diseases, loss of muscle mass, often referred to as cachexia, is a relevant systemic complication that leads to decreased muscle strength and endurance, reduced physical activity and fitness.
However, there is no study reporting variation in lower extremity information, muscle development, morphological effects measured by ultrasound, muscle strength and disease intensity in AS patients. Therefore, this study was conducted to determine whether there is a decrease in muscle according to the wide general spread in AS patients and to strengthen the detachable lower extremity structure with AS, muscle strength and possible presence. The relationship between strength, power and mobility of skeletal muscles was also evaluated. Although muscle loss was not morphologically evident in previous ultrasounds, it has not been investigated whether this leads to loss of muscle strength.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ankylosing Spondylitis | – | –Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Rivermead Mobility Index (RMI) will be evaluated. Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer. |
| Volunteers | – | –Voluntary participants will be admitted to this group. Vastus Lateralis, Tibialis Anterior, Lateral Gastrocnemius and Medial Gastrocnemius ultrasonography will be performed to evaluate muscle thickness, pennation angle and fascicle length. Isometric knee extension, isometric ankle dorsiflexion and isometric ankle plantar flexion strength will be evaluated with hand held dynamometer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Patients who applied to the Bezmialem Vakıf University, Physical Medicine and Rehabilitation Outpatient Clinic appropriate for eligibility criteria will be enrolled.
Key inclusion criteria (5 listed)
- Being ≥18 years old,
- Being diagnosed with AS according to The Assesment of Spondyloarthritis international society (ASAS) criteria
- Ability to giving consent
- Ability to live independently
- Ability to walk without assistive devices.
Key exclusion criteria (6 listed)
- History of surgery on the spine or lower extremities,
- History of inflammatory rheumatic disease,
- Severe cardiovascular disease,
- Neuromuscular disease affecting muscle strength,
- Individuals following a regular exercise program,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: 1 Day
It evaluates disease-specific symptoms such as fatigue, spinal and peripheral joint pain, swelling and morning stiffness and is interpreted on a score ranging from 0 to 10. Each question is scored on a scale of 0 to 10. Aside from the last question, 0 indicates none and 10 indicate very severe. For the last question, 0 is 0 hours, 5 is one hour, and 10 is two or more hours. To calculate the BASDAI score, the formula is: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 1 Day
It is an index that is fast and easy to apply, sensitive to changes and reliable, developed for determining and monitoring the functional status of patients with AS. It consists of 10 questions that evaluate patients' abilities to bend, reach, stand, change positions, climb stairs, and cope with activities of daily living. For each question, the final score is obtained by dividing the total score by 10 using the visual analogue scale (VAS) in the range of 0-10 cm. A higher score indicates a higher degree of functional limitations.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: 1 Day
BASMI consists of five clinical measurements: cervical rotation, tragus wall distance, lumbar flexion, trunk lateral flexion, and intermalleolar distance. It was first developed as a two-point scale in 1994 and was later adapted to a 10-point score. The 10-point BASMI scale was used in our study.The higher the BASMI score the more severe the patient's limitation of movement due to their Ankylosing Spondylitis.
Rivermead Mobility Index
Time frame: 1 Day
It is a one-dimensional index that focuses on measuring mobility status and includes basic mobility activities. It includes a series of hierarchical activities, from turning over in bed to running, consisting of 14 questions and one observation that fit the Guttman Scale. RMI was mainly developed for the purpose of evaluating the results of physiotherapy interventions after head trauma or stroke, and it is reported that it can be used in hospitals, outpatient clinics or home environments without requiring expertise. Self-reporting is essential in answering questions. Only the 5th item is observed and evaluated by the interviewer. 1 point is given for each "yes" answer and a range of 0-15 points can be received. A score of 15 points indicates that there is no problem in mobility, and a score of 14 points and below indicates that there is a mobility problem.
Isometric Knee Extension Muscle Strength
Time frame: 1 Day
Isometric Knee Extension Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Isometric Ankle Dorsiflexion Muscle Strength
Time frame: 1 Day
Isometric Ankle Dorsiflexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
Isometric Ankle Plantar Flexion Muscle Strength
Time frame: 1 Day
Isometric Ankle Plantar Flexion Muscle Strength will be calculated with hand-held dynamometer(Lafayette Manual Muscle Tester ) and reported as kilograms.
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 19 Mar 2024.
- Background: PubMed 23973125Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.
- Background: PubMed 9132215Walton JM, Roberts N, Whitehouse GH. Measurement of the quadriceps femoris muscle using magnetic resonance and ultrasound imaging. Br J Sports Med. 1997 Mar;31(1):59-64. doi: 10.1136/bjsm.31.1.59.
- Background: PubMed 32429993Blum D, Rodrigues R, Geremia JM, Brenol CV, Vaz MA, Xavier RM. Quadriceps muscle properties in rheumatoid arthritis: insights about muscle morphology, activation and functional capacity. Adv Rheumatol. 2020 May 19;60(1):28. doi: 10.1186/s42358-020-00132-w.
- Background: PubMed 31016579Aily JB, de Noronha M, de Almeida AC, Pedroso MG, Maciel JG, Mattiello-Sverzut AC, Mattiello SM. Evaluation of vastus lateralis architecture and strength of knee extensors in middle-aged and older individuals with knee osteoarthritis. Clin Rheumatol. 2019 Sep;38(9):2603-2611. doi: 10.1007/s10067-019-04539-9. Epub 2019 Apr 23.
- Background: PubMed 26279270Rastelli F, Capodaglio P, Orgiu S, Santovito C, Caramenti M, Cadioli M, Falini A, Rizzo G, Lafortuna CL. Effects of muscle composition and architecture on specific strength in obese older women. Exp Physiol. 2015 Oct;100(10):1159-67. doi: 10.1113/EP085273. Epub 2015 Sep 10.
- Background: PubMed 29860356van der Heijde D, Braun J, Deodhar A, Baraliakos X, Landewe R, Richards HB, Porter B, Readie A. Modified stoke ankylosing spondylitis spinal score as an outcome measure to assess the impact of treatment on structural progression in ankylosing spondylitis. Rheumatology (Oxford). 2019 Mar 1;58(3):388-400. doi: 10.1093/rheumatology/key128.
- Background: PubMed 12048660Wang CY, Olson SL, Protas EJ. Test-retest strength reliability: hand-held dynamometry in community-dwelling elderly fallers. Arch Phys Med Rehabil. 2002 Jun;83(6):811-5. doi: 10.1053/apmr.2002.32743.
- Background: PubMed 17717119Blazevich AJ, Cannavan D, Coleman DR, Horne S. Influence of concentric and eccentric resistance training on architectural adaptation in human quadriceps muscles. J Appl Physiol (1985). 2007 Nov;103(5):1565-75. doi: 10.1152/japplphysiol.00578.2007. Epub 2007 Aug 23.
- Individual participant dataSharing planned: Undecided
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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.
Mehmet Serkan Kılıçoğlu, Ass.Prof. study director
Bezmialem Vakif 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 and Muscle Weakness, 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 5 inclusion and 6 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 19 Mar 2024. 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?
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: 1 Day). The study lists 7 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 NCT06226792, which also lists 8 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 19 Mar 2024.