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

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

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

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
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

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

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

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

Universidad de Extremadura

Investigators

  • 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)

February 15, 2024

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

May 5, 2024

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Estimated)

November 14, 2024

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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