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NCT Number: NCT07510789

Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis

This study aims to better understand different types of low back pain in patients with ankylosing spondylitis. Low back pain is a common problem in these patients and may affect daily activities and quality of life.

A total of 200 patients with ankylosing spondylitis who have had low back pain for at least three months will be included in the study. Participants will be evaluated during a single visit.

The study will assess pain severity, physical function, and quality of life using standard questionnaires. It will also examine how different pain types are related to these outcomes.

The results of this study may help improve the understanding of pain in ankylosing spondylitis and support better patient management.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Konya Beyhekim Eğitim Araştırma Hastanesi

Konya, Selçuklu, 42060, Turkey (Türkiye)

Location status: Recruiting

Location contact

Enes Temiztürk, doctor

CONTACT

[email protected]

+905307394372

About this study

This prospective, hospital-based study is designed to expand the phenotypic characterization of inflammatory low back pain in patients with ankylosing spondylitis and to investigate the relationship between pain phenotypes, their cognitive-emotional components, and their impact on functional status and quality of life. Patients diagnosed with ankylosing spondylitis who present with chronic low back pain persisting for at least three months will be consecutively recruited from the Physical Therapy and Rehabilitation outpatient clinics of Konya Beyhekim Training and Research Hospital. All participants will undergo a standardized, single-session evaluation conducted by trained clinicians.

Pain intensity and its cognitive-emotional dimensions will be assessed using the Visual Analog Scale (VAS) and the Pain Catastrophizing Scale (PCS). Functional status will be evaluated with the Roland-Morris Disability Questionnaire (RMDQ). Disease activity, functional impairment, and quality of life will be assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), respectively. In addition, detailed sociodemographic and clinical data, including age, sex, body mass index, education level, employment status, and income level, will be recorded through structured interviews.

Pain mechanisms will be classified into three categories based on validated tools and accepted clinical criteria. Neuropathic pain will be identified using the DN4 (Douleur Neuropathique 4 Questions) questionnaire, with scores above the established cutoff indicating neuropathic pain. Nociplastic pain will be determined according to current clinical criteria and grading approaches for musculoskeletal nociplastic pain. Patients who do not meet criteria for neuropathic or nociplastic pain will be classified as having nociceptive pain. This classification will enable a multidimensional evaluation of pain beyond traditional inflammatory definitions.

Due to the absence of directly comparable studies in the literature, an a priori power analysis could not be performed. Recruitment will continue until a target sample size of 200 participants is achieved. Following data collection, a post hoc power analysis will be conducted using appropriate statistical methods. If the calculated statistical power is below 80%, recruitment will be extended until adequate power is obtained. All participants will undergo detailed medical history taking and physical examination as part of the study protocol.

This study is expected to provide a more comprehensive understanding of pain heterogeneity in ankylosing spondylitis and to clarify the contribution of different pain mechanisms and cognitive-emotional factors to functional limitations and reduced quality of life.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Being over 18 years of age Voluntary participation in the study Having been diagnosed with ankylosing spondylitis

Exclusion criteria

  • Those under 18 years of age
  • Those with major psychiatric illnesses
  • Those with communication problems
  • Other causes of back pain

Treatment and study plan

Primary outcomes

  1. Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis (Back Paın)

    Time frame: Baseline

    disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ)

  2. Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing

    Time frame: Baseline

    Quality of life will be assessed using the SF-36

Study contacts

Contact information is provided by the study sponsor or research team.

Enes Temiztürk, doctor

CONTACT

[email protected]

+905307394372

savaş karpuz, assocıate professor doctor

CONTACT

[email protected]

+905552057860

Sponsors and collaborators

Lead sponsor

Konya Beyhekim Training and Research Hospital

Other Gov

Registry information

Official study title

The Impact of Low Back Pain Phenotypes on Pain Intensity, Functional Status, and Quality of Life in Patients With Ankylosing Spondylitis

Acronym: Backpaın

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

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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