- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07510789
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
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Enes Temiztürk, doctor
- Phone Number: +905307394372
- Email: enis.t.turk@gmail.com
Study Contact Backup
- Name: savaş karpuz, assocıate professor doctor
- Phone Number: +905552057860
- Email: svskrpz@hotmail.com
Study Locations
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Selçuklu
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Konya, Selçuklu, Turkey (Türkiye), 42060
- Recruiting
- Konya Beyhekim Eğitim Araştırma Hastanesi
-
Contact:
- Enes Temiztürk, doctor
- Phone Number: +905307394372
- Email: enis.t.turk@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Study Director: savaş karpuz, Konya Beyhekim Eğitim Araştırma Hastanesi
Publications and helpful links
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Axial Spondyloarthritis
- Pain
- Neurologic Manifestations
- Bone Diseases
- Musculoskeletal Diseases
- Arthritis
- Joint Diseases
- Spinal Diseases
- Spondylarthropathies
- Ankylosis
- Spondylarthritis
- Spondylitis
- Back Pain
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Spondylitis, Ankylosing
- Low Back Pain
Other Study ID Numbers
- KONYA-BEYHEKIM-TRH-2023-361
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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