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NCT Number: NCT06688929

Psychosocial and Functional Factors in AxSpA

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.

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Key information

Conditions

Spondyloarthropathies Ankylosing Spondylitis (AS) Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Extremadura

Badajoz, 06006, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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."

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Extremadura

Other

Registry information

Official study title

Psychosocial and Functional Interactions in the Characterization of Axial Spondyloarthritis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 14, 2024
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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