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

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

Study Overview

Status

Recruiting

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: savaş karpuz, assocıate professor doctor
  • Phone Number: +905552057860
  • Email: svskrpz@hotmail.com

Study Locations

    • Selçuklu
      • Konya, Selçuklu, Turkey (Türkiye), 42060
        • Recruiting
        • Konya Beyhekim Eğitim Araştırma Hastanesi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

200 patients with Ankylosing Spondylitis who applied to the physical therapy and rehabilitation clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months will be included in the study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: savaş karpuz, Konya Beyhekim Eğitim Araştırma Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Shraim MA, Massé-Alarie H, Hodges PW. Methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a systematic review. 2021;162(4):1007-37.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 12, 2025

First Submitted That Met QC Criteria

March 30, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 30, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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