SpondyloarthropathiesNCT06688929
Psychosocial and Functional Factors in AxSpA
An observational study of Spondyloarthropathies and Ankylosing Spondylitis (AS), run by Universidad de Extremadura at 1 site in Spain.
Trial summary
This observational, cross-sectional study aims to characterize patients with axial spondyloarthritis (AxSpA) from a biopsychosocial perspective. The study examines the relationships between psychosocial factors (such as pain catastrophizing, kinesiophobia, and fear-avoidance beliefs) and clinical indicators of disease… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthropathies, Ankylosing Spondylitis (AS)
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- 15 Feb 2024to 5 May 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults diagnosed with axial spondyloarthritis who meet the inclusion criteria and are recruited from healthcare facilities specializing in the treatment of musculoskeletal conditions.
Who may be able to join
- Adults (18 years and older) diagnosed with axial spondyloarthritis (AxSpA) based on the Assessment of SpondyloArthritis International Society (ASAS) criteria.
- Experiencing symptoms of axial or peripheral involvement.
- A minimum score of 3/10 on the Numeric Pain Rating Scale (NPRS) during the initial assessment.
Who cannot join
- Individuals with other rheumatic or musculoskeletal conditions affecting the spine or joints (e.g., rheumatoid arthritis or osteoarthritis).
- History of spinal surgery or joint replacement surgery.
- Receipt of corticosteroid injections or other pharmacological treatments targeting inflammation within six weeks prior to data collection.
- Any ongoing medico-legal conflicts that could interfere with study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis
This observational, cross-sectional study aims to characterize patients with axial spondyloarthritis (AxSpA) from a biopsychosocial perspective. The study examines the relationships between psychosocial factors (such as pain catastrophizing, kinesiophobia, and fear-avoidance beliefs) and clinical indicators of disease progression, including functional limitations and disease activity. The primary objective is to identify psychosocial predictors of functionality and disease activity in AxSpA patients, which may guide more personalized therapeutic interventions. Findings could provide insights into the combined effects of physical and psychological aspects on disease management, promoting a holistic approach to AxSpA care.
- Conditions
- Spondyloarthropathies, Ankylosing Spondylitis (AS)
- Medical subject headings
- Spondylarthropathies, Spondylitis, Ankylosing
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 |
|---|---|---|
| Axial Spondyloarthritis Patients | A cohort of adult patients diagnosed with axial spondyloarthritis (AxSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria. These patients will be evaluated to analyze the impact of psychosocial factors on disease progression, functionality, and quality of life. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
This primary outcome measure will assess disease activity in patients with axial spondyloarthritis using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI is a validated, self-reported measure that evaluates symptoms such as fatigue, spinal pain, joint pain, and morning stiffness on a scale from 0 to 10, where higher scores indicate higher disease activity.
Measured: Baseline (single assessment at the start of the study)
Bath Ankylosing Spondylitis Functional Index (BASFI)
A self-reported index measuring functional limitations in ankylosing spondylitis patients. It evaluates the ability to perform daily activities, with scores ranging from 0 to 10, where higher scores indicate greater functional impairment.
Measured: Baseline (single assessment at the start of the study)
Bath Ankylosing Spondylitis Metrology Index (BASMI)
An index measuring spinal mobility in ankylosing spondylitis, using measurements of lateral lumbar flexion, tragus-to-wall distance, cervical rotation, lumbar flexion (modified Schober test), and intermalleolar distance. Each component is scored on a continuous scale from 0 to 10.
Measured: Baseline
Secondary outcomes (5)
Numeric Pain Rating Scale (NPRS)
A numeric rating scale for pain, where patients rate their pain intensity on a scale from 0 to 10, with 0 meaning "no pain" and 10 "the worst pain imaginable."
Measured: Baseline
Range of Motion (ROM)
Cervical range of motion will be measured using a goniometer for flexion/extension, lateral flexion, and rotation movements. Lumbar flexion will be assessed using the modified Schober test.
Measured: Baseline
Pressure Pain Threshold (PPT)
Pressure pain threshold will be assessed at specific points, such as the upper trapezius, lumbar erector spinae at L3-L4, and epicondyle muscles, using a mechanical pressure algometer.
Measured: Baseline
Cervical Joint Position Sense Error (JPSE)
Assesses cervical proprioceptive acuity by measuring the error in repositioning the head to a neutral posture.
Measured: Baseline
Lumbar Repositioning Error (LRE)
Assesses lumbar proprioception by measuring the error in repositioning after flexing the lumbar spine to a specific angle.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start15 Feb 2024
- Primary completion12 Mar 2024
- Study completion5 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthropathiesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Extremadura
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Fernández-Morales, Universidad de Extremadura
- Investigators
- Luis Espejo-Antúnez, Ph.D., Study director, University of Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688929
- Sponsor's protocol ID
- 07
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis
- ClinicalTrials.gov ID
- NCT06688929
- Acronym / sponsor ID
- 07
- Conditions
- Spondyloarthropathies, Ankylosing Spondylitis (AS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universidad de ExtremaduraUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 14 Nov 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.
This observational, cross-sectional study aims to characterize patients with axial spondyloarthritis (AxSpA) from a biopsychosocial perspective. The study examines the relationships between psychosocial factors (such as pain catastrophizing, kinesiophobia, and fear-avoidance beliefs) and clinical indicators of disease progression, including functional limitations and disease activity. The primary objective is to identify psychosocial predictors of functionality and disease activity in AxSpA patients, which may guide more personalized therapeutic interventions. Findings could provide insights into the combined effects of physical and psychological aspects on disease management, promoting a holistic approach to AxSpA care.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Axial Spondyloarthritis Patients | – | –A cohort of adult patients diagnosed with axial spondyloarthritis (AxSpA) according to the Assessment of SpondyloArthritis International Society (ASAS) criteria. These patients will be evaluated to analyze the impact of psychosocial factors on disease progression, functionality, and quality of life. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults diagnosed with axial spondyloarthritis who meet the inclusion criteria and are recruited from healthcare facilities specializing in the treatment of musculoskeletal conditions.
Key inclusion criteria (3 listed)
- Adults (18 years and older) diagnosed with axial spondyloarthritis (AxSpA) based on the Assessment of SpondyloArthritis International Society (ASAS) criteria.
- Experiencing symptoms of axial or peripheral involvement.
- A minimum score of 3/10 on the Numeric Pain Rating Scale (NPRS) during the initial assessment.
Key exclusion criteria (4 listed)
- Individuals with other rheumatic or musculoskeletal conditions affecting the spine or joints (e.g., rheumatoid arthritis or osteoarthritis).
- History of spinal surgery or joint replacement surgery.
- Receipt of corticosteroid injections or other pharmacological treatments targeting inflammation within six weeks prior to data collection.
- Any ongoing medico-legal conflicts that could interfere with study participation.
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: Baseline (single assessment at the start of the study)
This primary outcome measure will assess disease activity in patients with axial spondyloarthritis using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). The BASDAI is a validated, self-reported measure that evaluates symptoms such as fatigue, spinal pain, joint pain, and morning stiffness on a scale from 0 to 10, where higher scores indicate higher disease activity.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline (single assessment at the start of the study)
A self-reported index measuring functional limitations in ankylosing spondylitis patients. It evaluates the ability to perform daily activities, with scores ranging from 0 to 10, where higher scores indicate greater functional impairment.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Baseline
An index measuring spinal mobility in ankylosing spondylitis, using measurements of lateral lumbar flexion, tragus-to-wall distance, cervical rotation, lumbar flexion (modified Schober test), and intermalleolar distance. Each component is scored on a continuous scale from 0 to 10.
5 secondary outcomes
Numeric Pain Rating Scale (NPRS)
Time frame: Baseline
Range of Motion (ROM)
Time frame: Baseline
Pressure Pain Threshold (PPT)
Time frame: Baseline
Cervical Joint Position Sense Error (JPSE)
Time frame: Baseline
Lumbar Repositioning Error (LRE)
Time frame: Baseline
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 14 Nov 2024.
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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.
Luis Espejo-Antúnez, Ph.D. study director
University of Extremadura
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 Spondyloarthropathies and Ankylosing Spondylitis (AS), run by Universidad de Extremadura at 1 site in Spain.
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 4 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 14 Nov 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 Spain. 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: Baseline (single assessment at the start of the study)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2024.