Psychosocial and Functional Factors in AxSpA

Completed

• Conditions: Spondyloarthropathies; Ankylosing Spondylitis (AS)

• Registration Number: NCT06688929
• Lead Sponsor: Universidad de Extremadura

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-15
• Primary Completion: 2024-03-12
• Study Completion: 2024-05-05
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Last Update Submitted: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 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.
Bath Ankylosing Spondylitis Metrology Index (BASMI)	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion (ROM)	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.
Numeric Pain Rating Scale (NPRS)	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."
Pressure Pain Threshold (PPT)	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.
Cervical Joint Position Sense Error (JPSE)	Baseline	Assesses cervical proprioceptive acuity by measuring the error in repositioning the head to a neutral posture.
Lumbar Repositioning Error (LRE)	Baseline	Assesses lumbar proprioception by measuring the error in repositioning after flexing the lumbar spine to a specific angle.

Trial Locations

Locations (1)

Universidad de Extremadura; 🇪🇸 Badajoz, Spain