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Psychosocial and Functional Factors in AxSpA

Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06688929
Enrollment
34
Registered
2024-11-14
Start date
2024-02-15
Completion date
2024-05-05
Last updated
2024-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis (AS), Spondyloarthropathies

Brief 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 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.

Interventions

None listed

Sponsors

Universidad de Extremadura
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)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 Metrology Index (BASMI)BaselineAn 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.
Bath Ankylosing Spondylitis Functional Index (BASFI)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.

Secondary

MeasureTime frameDescription
Cervical Joint Position Sense Error (JPSE)BaselineAssesses cervical proprioceptive acuity by measuring the error in repositioning the head to a neutral posture.
Lumbar Repositioning Error (LRE)BaselineAssesses lumbar proprioception by measuring the error in repositioning after flexing the lumbar spine to a specific angle.
Pressure Pain Threshold (PPT)BaselinePressure 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.
Numeric Pain Rating Scale (NPRS)BaselineA 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.
Range of Motion (ROM)BaselineCervical 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.

Other

MeasureTime frameDescription
Pain Catastrophizing Scale (PCS)BaselineA 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.
Fear-Avoidance Beliefs Questionnaire (FABQ)BaselineA 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.
Tampa Scale for Kinesiophobia (TSK-11)BaselineA 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026