Psychosocial and Functional Factors in AxSpA

NCT06688929 | Completed

• 1 other identifier: 07
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondyloarthropathies; Ankylosing Spondylitis (AS)

Outcome Measures

Primary Outcomes (3)

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  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)

  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)

  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 Outcomes (5)

• Numeric Pain Rating Scale (NPRS)

  Baseline

• Range of Motion (ROM)

  Baseline

• Pressure Pain Threshold (PPT)

  Baseline

• Cervical Joint Position Sense Error (JPSE)

  Baseline

• Lumbar Repositioning Error (LRE)

  Baseline

Other Outcomes (3)

• Pain Catastrophizing Scale (PCS)

  Baseline

• Tampa Scale for Kinesiophobia (TSK-11)

  Baseline

• Fear-Avoidance Beliefs Questionnaire (FABQ)

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Extremadura: lead

Study Sites (1)

Universidad de Extremadura

Badajoz, Badajoz, 06006, Spain

Location

MeSH Terms

Conditions

Spondylarthropathies; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Axial Spondyloarthritis; Ankylosis

Study Officials

• Luis Espejo-Antúnez, Ph.D.

  University of Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: February 15, 2024
• Primary Completion: March 12, 2024
• Study Completion: May 5, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

ES (1)