Chronic Nonspecific Low Back PainNCT06113185
Turkish Pain Behaviour Scale in Adults With Chronic Nonspecific Low Back Pain
An observational study of Chronic Nonspecific Low Back Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to translate and culturally adapt the Pain Behaviour Scale (PaBS) into Turkish and to evaluate its psychometric properties in adults with chronic nonspecific low back pain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Turkish Pain Behaviour Scale Assessment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Adults with chronic nonspecific low back pain were recruited using a non-probabilistic sampling strategy from physical therapy and rehabilitation outpatient clinics of private hospitals and a university-based physiotherapy and rehabilitation education and research laboratory. Eligible participants were aged 18-55 years and had chronic nonspecific low back pain lasting longer than 3 months.
Who may be able to join
- Adults aged 18-55 years
- Chronic nonspecific low back pain lasting longer than 3 months
- Sufficient cognitive and language ability to understand study instructions, complete questionnaires, and provide informed consent
Who cannot join
- Clinical features suggesting serious spinal pathology, including malignancy, infection, fracture, or cauda equina syndrome
- Spinal stenosis
- Signs of radiculopathy, including radiating leg pain, weakness, numbness, or tingling
- Previous fracture or surgery in the relevant spinal region
- History of rheumatic disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Health Group
Istanbul, None Selected, 34752
About this study
Official title: Reliability and Validity of the Turkish Pain Behaviour Scale in Adults With Chronic Nonspecific Low Back Pain
The aim of this study was to translate and culturally adapt the Pain Behaviour Scale (PaBS) into Turkish and to evaluate its psychometric properties in adults with chronic nonspecific low back pain. Specifically, the study examined interrater reliability, intrarater reliability, agreement, measurement error, and construct validity of the Turkish version of the PaBS during standardized functional performance tasks.
Read the detailed description
The Pain Behaviour Scale (PaBS) is a clinician-rated observational measure designed to assess the presence and severity of pain behaviors during functional movement in individuals with chronic low back pain. Before its use in Turkish-speaking populations, translation, cross-cultural adaptation, and psychometric evaluation were required.
In this cross-cultural adaptation and psychometric validation study, the PaBS was translated into Turkish, back-translated, reviewed by an expert panel, and pilot-tested before the main psychometric evaluation. The prefinal Turkish version was pilot-tested in 20 adults with chronic nonspecific low back pain, and the pilot data were not included in the main analyses.
The main study included adults aged 18-55 years with chronic nonspecific low back pain lasting more than three months. Participants completed self-reported measures of pain, disability, and fear-avoidance beliefs and performed standardized physical performance tests. During the first testing session, two independent physiotherapists simultaneously rated pain behaviors using the Turkish PaBS. One rater repeated the PaBS assessment approximately one week later. The psychometric evaluation included interrater and intrarater reliability, agreement, measurement error, and construct validity.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Turkish Pain Behaviour Scale Assessment
- Keywords
- Psychometric Properties, Pain Behavior Scale, Cross-Cultural Adaptation, Reliability, Validity, Pain Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Pain Behaviour Scale AssessmentOther
Participants completed self-report measures of pain intensity and characteristics, disability, and fear-avoidance beliefs and performed five standardized physical performance tests: repeated trunk flexion, repeated sit-to-stand, Timed Up and Go, loaded reach, and 50-foot walk. During the first testing session, two independent physiotherapists simultaneously assessed the presence and severity of pain behaviors using the Turkish Pain Behaviour Scale (PaBS). For intrarater reliability, one rater repeated the PaBS assessment during a second testing session approximately one week later. No therapeutic intervention was administered as part of the study assessments.
| Study group | Role | What they receive |
|---|---|---|
| Adults With Chronic Nonspecific Low Back Pain | A total of 102 adults aged 18-55 years with chronic nonspecific low back pain lasting more than 3 months were included in the psychometric validation study. Participants underwent standardized clinical, self-report, and physical performance assessments during two testing sessions separated by approximately one week. Receives: Other: Turkish Pain Behaviour Scale Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turkish Pain Behaviour Scale (PaBS)
The Turkish Pain Behaviour Scale (PaBS) is a clinician-rated observational measure used to assess the presence and severity of pain behaviors during five standardized physical performance tests. Observed behaviors include sighing, breath-holding, grimacing, guarding, rubbing, and antalgic gait. For each physical performance test, the presence or absence of individual behaviors is recorded and the overall severity of observed pain behavior is rated from 0 to 3. The total PaBS severity score ranges from 0 to 15, with higher scores indicating greater severity of observed pain behaviors. Interrater reliability was evaluated using ratings from two independent raters during the first testing session, and intrarater reliability was evaluated using ratings from the same rater across two testing sessions.
Measured: Baseline and approximately 1 week
Secondary outcomes (4)
Oswestry Disability Index (ODI)
Low back pain-related disability was assessed using the Oswestry Disability Index (ODI). The total score is expressed as a percentage, with higher scores indicating greater disability.
Measured: Baseline and approximately 1 week
Fear-Avoidance Beliefs Questionnaire (FABQ)
Fear-avoidance beliefs were assessed using the Fear-Avoidance Beliefs Questionnaire (FABQ), including the physical activity and work subscales and the total score. Higher scores indicate greater fear-avoidance beliefs.
Measured: Baseline and approximately 1 week
Short-Form McGill Pain Questionnaire (SF-MPQ)
Pain characteristics were assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ), including sensory and affective pain descriptors. Sensory, affective, and total scores were recorded, with higher scores indicating greater pain-related symptom burden.
Measured: Baseline and approximately 1 week
MPQ-VAS Pain Intensity
Pain intensity was assessed using the visual analog scale component of the Short-Form McGill Pain Questionnaire (MPQ-VAS). Higher scores indicate greater pain intensity.
Measured: Baseline and approximately 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start1 Apr 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif E Bayraktar, asst. prof., Principal investigator, Acibadem Healthcare GroupIrmak Çavuşoğlu, asst. prof., Study chair, Kırklareli UniversityNuray Alaca, assoc. prof., Study director, Acibadem Healthcare GroupYağmur İldeniz, MSc, Study chair, Acibadem Healthcare Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113185
- Sponsor's protocol ID
- 2023-15/518
- Status last verified
- Aug 2026
- First submitted
- 24 Oct 2023
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to ethical and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Turkish Pain Behaviour Scale in Adults With Chronic Nonspecific Low Back Pain
- ClinicalTrials.gov ID
- NCT06113185
- Acronym / sponsor ID
- 2023-15/518
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Psychometric Properties, Pain Behavior Scale, Cross-Cultural Adaptation, Reliability, Validity, Pain Measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 2 Nov 2023 (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.
The aim of this study was to translate and culturally adapt the Pain Behaviour Scale (PaBS) into Turkish and to evaluate its psychometric properties in adults with chronic nonspecific low back pain. Specifically, the study examined interrater reliability, intrarater reliability, agreement, measurement error, and construct validity of the Turkish version of the PaBS during standardized functional performance tasks.
Detailed description
The Pain Behaviour Scale (PaBS) is a clinician-rated observational measure designed to assess the presence and severity of pain behaviors during functional movement in individuals with chronic low back pain. Before its use in Turkish-speaking populations, translation, cross-cultural adaptation, and psychometric evaluation were required.
In this cross-cultural adaptation and psychometric validation study, the PaBS was translated into Turkish, back-translated, reviewed by an expert panel, and pilot-tested before the main psychometric evaluation. The prefinal Turkish version was pilot-tested in 20 adults with chronic nonspecific low back pain, and the pilot data were not included in the main analyses.
The main study included adults aged 18-55 years with chronic nonspecific low back pain lasting more than three months. Participants completed self-reported measures of pain, disability, and fear-avoidance beliefs and performed standardized physical performance tests. During the first testing session, two independent physiotherapists simultaneously rated pain behaviors using the Turkish PaBS. One rater repeated the PaBS assessment approximately one week later. The psychometric evaluation included interrater and intrarater reliability, agreement, measurement error, and construct validity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults With Chronic Nonspecific Low Back Pain | – | Other: Turkish Pain Behaviour Scale AssessmentA total of 102 adults aged 18-55 years with chronic nonspecific low back pain lasting more than 3 months were included in the psychometric validation study. Participants underwent standardized clinical, self-report, and physical performance assessments during two testing sessions separated by approximately one week. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Adults with chronic nonspecific low back pain were recruited using a non-probabilistic sampling strategy from physical therapy and rehabilitation outpatient clinics of private hospitals and a university-based physiotherapy and rehabilitation education and research laboratory. Eligible participants were aged 18-55 years and had chronic nonspecific low back pain lasting longer than 3 months.
Key inclusion criteria (3 listed)
- Adults aged 18-55 years
- Chronic nonspecific low back pain lasting longer than 3 months
- Sufficient cognitive and language ability to understand study instructions, complete questionnaires, and provide informed consent
Key exclusion criteria (6 listed)
- Clinical features suggesting serious spinal pathology, including malignancy, infection, fracture, or cauda equina syndrome
- Spinal stenosis
- Signs of radiculopathy, including radiating leg pain, weakness, numbness, or tingling
- Previous fracture or surgery in the relevant spinal region
- History of rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turkish Pain Behaviour Scale AssessmentParticipants completed self-report measures of pain intensity and characteristics, disability, and fear-avoidance beliefs and performed five standardized physical performance tests: repeated trunk flexion, repeated sit-to-stand, Timed Up and Go, loaded reach, and 50-foot walk. During the first testing session, two independent physiotherapists simultaneously assessed the presence and severity of pain behaviors using the Turkish Pain Behaviour Scale (PaBS). For intrarater reliability, one rater repeated the PaBS assessment during a second testing session approximately one week later. No therapeutic intervention was administered as part of the study assessments. | Other | Adults With Chronic Nonspecific Low Back Pain |
Primary outcome
Turkish Pain Behaviour Scale (PaBS)
Time frame: Baseline and approximately 1 week
The Turkish Pain Behaviour Scale (PaBS) is a clinician-rated observational measure used to assess the presence and severity of pain behaviors during five standardized physical performance tests. Observed behaviors include sighing, breath-holding, grimacing, guarding, rubbing, and antalgic gait. For each physical performance test, the presence or absence of individual behaviors is recorded and the overall severity of observed pain behavior is rated from 0 to 3. The total PaBS severity score ranges from 0 to 15, with higher scores indicating greater severity of observed pain behaviors. Interrater reliability was evaluated using ratings from two independent raters during the first testing session, and intrarater reliability was evaluated using ratings from the same rater across two testing sessions.
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline and approximately 1 week
Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and approximately 1 week
Short-Form McGill Pain Questionnaire (SF-MPQ)
Time frame: Baseline and approximately 1 week
MPQ-VAS Pain Intensity
Time frame: Baseline and approximately 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to ethical and data protection considerations.
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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. This study is not recruiting at the moment.
Elif E Bayraktar, asst. prof. principal investigator
Acibadem Healthcare Group
Irmak Çavuşoğlu, asst. prof. study chair
Kırklareli University
Nuray Alaca, assoc. prof. study director
Acibadem Healthcare Group
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 Chronic Nonspecific Low Back Pain, run by Acibadem University 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turkish Pain Behaviour Scale (PaBS) (time frame: Baseline and approximately 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.