Ankylosing SpondylitisBackpaınNCT07510789
Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis and Low Back Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis, Low Back Pain
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Being over 18 years of age Voluntary participation in the study Having been diagnosed with ankylosing spondylitis
Who cannot join
- Those under 18 years of age
- Those with major psychiatric illnesses
- Those with communication problems
- Other causes of back pain
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Konya Beyhekim Eğitim Araştırma Hastanesi
Konya, Selçuklu, 42060
Enes Temiztürk, doctor, +905307394372, enis.t.turk@gmail.com
About this study
Official title: 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.
Read more
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.
- Conditions
- Ankylosing Spondylitis, Low Back Pain
- Keywords
- ankylosing spondylitis, types of paın, lower back pain
- Medical subject headings
- Spondylitis, Ankylosing, Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing
Quality of life will be assessed using the SF-36
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start1 Dec 2025
- Primary completion1 Dec 2025
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konya Beyhekim Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- savaş karpuz, Study director, konya beyhekim eğitim araştırma hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510789
- Sponsor's protocol ID
- KONYA-BEYHEKIM-TRH-2023-361
- Acronym
- Backpaın
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Low Back Pain Phenotypes on Pain Intensity, Functional Status, and Quality of Life in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07510789
- Acronym / sponsor ID
- Backpaın / KONYA-BEYHEKIM-TRH-2023-361
- Conditions
- Ankylosing Spondylitis, Low Back Pain
- Keywords
- ankylosing spondylitis, types of paın, lower back pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Konya Beyhekim Training and Research HospitalOther government
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Being over 18 years of age Voluntary participation in the study Having been diagnosed with ankylosing spondylitis
Key exclusion criteria (4 listed)
- Those under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 33136983Shraim 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
savaş karpuz study director
konya beyhekim eğitim araştırma hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis and Low Back Pain, run by Konya Beyhekim Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Enes Temiztürk, doctor (+905307394372, enis.t.turk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Low Back Pain Phenotypes on Function and Quality of Life in Ankylosing Spondylitis (Back Paın) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07510789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.