Psychosocial and Functional Factors in AxSpA

November 12, 2024 updated by: Carlos Fernández-Morales, Universidad de Extremadura

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Badajoz, Spain, 06006
        • Universidad de Extremadura

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline (single assessment at the start of the study)
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.
Baseline (single assessment at the start of the study)
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.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Baseline
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."
Baseline
Range of Motion (ROM)
Time Frame: Baseline
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.
Baseline
Pressure Pain Threshold (PPT)
Time Frame: Baseline
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.
Baseline
Cervical Joint Position Sense Error (JPSE)
Time Frame: Baseline
Assesses cervical proprioceptive acuity by measuring the error in repositioning the head to a neutral posture.
Baseline
Lumbar Repositioning Error (LRE)
Time Frame: Baseline
Assesses lumbar proprioception by measuring the error in repositioning after flexing the lumbar spine to a specific angle.
Baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain Catastrophizing Scale (PCS)
Time Frame: Baseline
A self-reported scale that measures catastrophic thinking related to pain, including thoughts and feelings associated with pain experiences. It consists of 13 items rated on a Likert scale from 0 to 4, with higher scores indicating greater catastrophizing.
Baseline
Tampa Scale for Kinesiophobia (TSK-11)
Time Frame: Baseline
A scale that measures fear of movement and re-injury, consisting of 11 items rated on a scale from 1 to 4, with higher scores indicating greater fear of movement.
Baseline
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time Frame: Baseline
A questionnaire that assesses fear-avoidance beliefs related to physical activity and work in individuals with musculoskeletal pain. It includes two subscales: one for physical activity (FABQ-PA) and another for work-related fear-avoidance (FABQ-W), with items rated on a scale from 0 to 6.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Extremadura

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Luis Espejo-Antúnez, Ph.D., University of Extremadura

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 12, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 12, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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