Clinical trial NCT06688929: Psychosocial and Functional Factors in AxSpA
Official title: Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondyloarthropathies
Ankylosing Spondylitis (AS)
Lead sponsor: Universidad de Extremadura
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Baseline (single assessment at the start of the study)
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Baseline (single assessment at the start of the study)
measure: Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Baseline
measure: Range of Motion (ROM)
timeFrame: Baseline
measure: Pressure Pain Threshold (PPT)
timeFrame: Baseline
measure: Cervical Joint Position Sense Error (JPSE)
timeFrame: Baseline
measure: Lumbar Repositioning Error (LRE)
timeFrame: Baseline
Other outcomes:
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Baseline
measure: Fear-Avoidance Beliefs Questionnaire (FABQ)
timeFrame: Baseline
Locations:
city: Badajoz
country: Spain
facility: Universidad de Extremadura
Study officials:
affiliation: University of Extremadura
name: Luis Espejo-Antúnez, Ph.D.
role: STUDY_DIRECTOR
References: