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RecruitingNCT07510789BackpaınUpdated Apr 3, 2026

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

An observational study in Ankylosing Spondylitis and Low Back Pain, sponsored by Konya Beyhekim Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-03.

Sponsored by Konya Beyhekim Training and Research Hospital · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis
  • Low Back Pain

Keywords

  • ankylosing spondylitis
  • types of paın
  • lower back pain
03

In context

Spondylitis, Ankylosing

498 studies on the registry are indexed under Spondylitis, Ankylosing; 89 are open to participants now.

This study's planned enrollment of 200 is close to the median of 200 across 210 observational studies indexed under Spondylitis, Ankylosing.

Browse Spondylitis, Ankylosing studies →

Lead sponsor

Konya Beyhekim Training and Research Hospital is the lead sponsor of 31 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Those under 18 years of age

    • Those with major psychiatric illnesses
    • Those with communication problems
    • Other causes of back pain
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

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

    Time frame: Baseline

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

    Quality of life will be assessed using the SF-36

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Konya Beyhekim Eğitim Araştırma Hastanesi
    Konya, Selçuklu 42060, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • Shraim MA, Masse-Alarie H, Hodges PW. Methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a systematic review. Pain. 2021 Apr 1;162(4):1007-1037. doi: 10.1097/j.pain.0000000000002113. PubMed 33136983 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07510789
Lead sponsor
Konya Beyhekim Training and Research Hospital
Responsible party
Sponsor
First posted
Apr 3, 2026
Start date
Dec 1, 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026 (estimated)
Last update
Apr 3, 2026

Study contacts

Enes Temiztürk, doctor
Contact
enis.t.turk@gmail.com
+905307394372
savaş karpuz, assocıate professor doctor
Contact
svskrpz@hotmail.com
+905552057860
savaş karpuz
study director · konya beyhekim eğitim araştırma hastanesi

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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