MIC of Turkish Pain-related Psychological Measures

An observational study of Chronic Low-back Pain, run by Acibadem University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This study evaluates the responsiveness and minimal important change of the Turkish versions of the Fear-Avoidance Beliefs Questionnaire, Tampa Scale for Kinesiophobia, and Pain Catastrophizing Scale in adults with chronic non-specific low back pain undergoing a 4-week rehabilitation program. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Low-back Pain
What is being tested?: Standardized Rehabilitation Program
How many people: 124 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 9 Dec 2024to 6 Mar 2026
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: The study population consisted of adults aged 18-65 years with chronic non-specific low back pain lasting more than 12 weeks without a recognizable specific pathoanatomical cause. Participants were recruited from private hospital outpatient clinics and a university-based physiotherapy laboratory. A total of 124 participants were enrolled, of whom 110 completed the 4-week follow-up assessment. Eligible participants provided written informed consent before enrollment.

Who may be able to join

Adults aged 18-65 years
Chronic non-specific low back pain persisting for more than 12 weeks without a recognizable specific pathoanatomical cause
Ability to read and understand Turkish
Sufficient cognitive ability to complete self-reported questionnaires, defined as a Standardized Mini-Mental Test score ≥24
Provision of written informed consent

Who cannot join

Radiculopathy
Spinal infection, tumor, osteoporosis, vertebral fracture, recent trauma, or previous lumbar surgery
Recent spinal injection
Systemic disease affecting participation or interpretation
Cognitive impairment
Myocardial infarction or cerebrovascular event within the previous 12 weeks

Show all 9Show fewer

Previous structured exercise therapy or pain neuroscience education for low back pain
Refusal of treatment
Inability to comply with the rehabilitation program

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Avicenna Ataşehir Hospital
Istanbul, None Selected, 34750

Other trials in Turkey (Türkiye)

About this study

Official title: Responsiveness and Minimal Important Change of Turkish Pain-Related Psychological Measures in Chronic Non-Specific Low Back Pain

Read the detailed description

Chronic non-specific low back pain is influenced by biological, psychological, and social factors, including fear-avoidance beliefs, kinesiophobia, and pain catastrophizing. The Fear-Avoidance Beliefs Questionnaire (FABQ), Tampa Scale for Kinesiophobia (TSK), and Pain Catastrophizing Scale (PCS) are commonly used to assess these pain-related psychological constructs.

This prospective, single-cohort measurement-property study evaluates the responsiveness of the Turkish versions of the FABQ, TSK, and PCS and examines their correspondence with patient-perceived global improvement. Participants undergo baseline assessment followed by a standardized 4-week rehabilitation program comprising 16 supervised physiotherapy sessions. Outcomes are reassessed after 4 weeks.

Responsiveness is evaluated using distribution-based indices and associations with the Global Rating of Change (GRC). Receiver operating characteristic analyses are used to examine discrimination between participants classified as improved and not improved and to estimate GRC-defined minimal important change values where appropriate.

Conditions: Chronic Low-back Pain
Being tested: Standardized Rehabilitation Program
Keywords: Chronic Low Back Pain, Responsiveness, Fear-Avoidance Beliefs, Kinesiophobia, Pain Catastrophizing, Rehabilitation, Minimal Important Change
Medical subject headings: Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standardized Rehabilitation ProgramOther
Participants completed 16 supervised 60-minute physiotherapy sessions over four weeks. The standardized core program comprised lumbar stabilization and trunk-strengthening exercises, lower-limb flexibility training, postural education, and weekly 45-minute pain-related cognitive education addressing pain neurophysiology, fear, avoidance, and safe movement. Superficial heat, conventional TENS, or therapeutic ultrasound could be added by the treating physiotherapist when clinically indicated.

What is being measured

The primary outcome is the main question the study is designed to answer.

Fear-Avoidance Beliefs Questionnaire (FABQ)
Fear-Avoidance Beliefs Questionnaire (FABQ) assesses fear-avoidance beliefs related to physical activity and work. The questionnaire consists of 16 items. The Physical Activity subscale includes items 2-5 and ranges from 0 to 24, while the Work subscale includes items 6, 7, 9-12, and 15 and ranges from 0 to 42. Higher scores indicate greater fear-avoidance beliefs.
Measured: Baseline and 4 weeks
Tampa Scale for Kinesiophobia (TSK)
Tampa Scale for Kinesiophobia (TSK) assesses fear of movement or reinjury. The scale consists of 17 items scored on a 4-point Likert scale. After reverse scoring of the relevant items, total scores range from 17 to 68, with higher scores indicating greater kinesiophobia.
Measured: Baseline and 4 weeks
Pain Catastrophizing Scale (PCS)
Pain Catastrophizing Scale (PCS) assesses catastrophic thinking related to pain. The scale consists of 13 items scored on a 0-4 Likert scale and provides Rumination, Magnification, Helplessness, and Total scores. Higher scores indicate greater pain catastrophizing.
Measured: Baseline and 4 weeks

Secondary outcomes (1)

Pain Intensity - Visual Analog Scale (VAS)
Visual Analog Scale (VAS) was used to assess pain intensity at rest and during activity. Pain intensity was recorded on a 10-cm scale, with higher scores indicating greater pain intensity.
Measured: Baseline and 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20246 Mar 2026

First posted21 Feb 2024
Study start9 Dec 2024
Primary completion6 Mar 2026
Study completion6 Mar 2026

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 Chronic 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: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06271447
Sponsor's protocol ID: 2023-21-705
Status last verified: Aug 2026
First submitted: 14 Feb 2024
Last updated: 1 Sep 2026
Results posted: No
Individual data sharing: No: Individual participant data will not be publicly shared due to privacy and ethical restrictions. De-identified data may be available from the corresponding author upon reasonable request and subject to applicable ethical and institutional requirements.

Publications

Bayraktar EE, Alaca N, Cavusoglu I, Ildeniz Y, Kocak A. Responsiveness and minimal important change of Turkish pain-related psychological measures in chronic non-specific low back pain. Ann Med. 2026 Dec;58(1):2725978. doi: 10.1080/07853890.2026.2725978. Epub 2026 Oct 5.
PubMed 42832343

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
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Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low-back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Responsiveness and Minimal Important Change of Turkish Pain-Related Psychological Measures in Chronic Non-Specific Low Back Pain
ClinicalTrials.gov ID: NCT06271447
Acronym / sponsor ID: 2023-21-705
Conditions: Chronic Low-back Pain
Keywords: Chronic Low Back Pain, Responsiveness, Fear-Avoidance Beliefs, Kinesiophobia, Pain Catastrophizing, Rehabilitation, Minimal Important Change
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: Acibadem UniversityUniversity, hospital or other
Study start: 9 Dec 2024 (actual)
Primary completion: 6 Mar 2026 (actual)
Study completion: 6 Mar 2026 (actual)
First posted: 21 Feb 2024 (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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population consisted of adults aged 18-65 years with chronic non-specific low back pain lasting more than 12 weeks without a recognizable specific pathoanatomical cause. Participants were recruited from private hospital outpatient clinics and a university-based physiotherapy laboratory. A total of 124 participants were enrolled, of whom 110 completed the 4-week follow-up assessment. Eligible participants provided written informed consent before enrollment.

Key inclusion criteria (5 listed)

Adults aged 18-65 years
Chronic non-specific low back pain persisting for more than 12 weeks without a recognizable specific pathoanatomical cause
Ability to read and understand Turkish
Sufficient cognitive ability to complete self-reported questionnaires, defined as a Standardized Mini-Mental Test score ≥24
Provision of written informed consent

Key exclusion criteria (9 listed)

Radiculopathy
Spinal infection, tumor, osteoporosis, vertebral fracture, recent trauma, or previous lumbar surgery
Recent spinal injection
Systemic disease affecting participation or interpretation
Cognitive impairment

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
Standardized Rehabilitation ProgramParticipants completed 16 supervised 60-minute physiotherapy sessions over four weeks. The standardized core program comprised lumbar stabilization and trunk-strengthening exercises, lower-limb flexibility training, postural education, and weekly 45-minute pain-related cognitive education addressing pain neurophysiology, fear, avoidance, and safe movement. Superficial heat, conventional TENS, or therapeutic ultrasound could be added by the treating physiotherapist when clinically indicated.	Other	–

Primary outcome

Fear-Avoidance Beliefs Questionnaire (FABQ)
Time frame: Baseline and 4 weeks
Fear-Avoidance Beliefs Questionnaire (FABQ) assesses fear-avoidance beliefs related to physical activity and work. The questionnaire consists of 16 items. The Physical Activity subscale includes items 2-5 and ranges from 0 to 24, while the Work subscale includes items 6, 7, 9-12, and 15 and ranges from 0 to 42. Higher scores indicate greater fear-avoidance beliefs.
Tampa Scale for Kinesiophobia (TSK)
Time frame: Baseline and 4 weeks
Tampa Scale for Kinesiophobia (TSK) assesses fear of movement or reinjury. The scale consists of 17 items scored on a 4-point Likert scale. After reverse scoring of the relevant items, total scores range from 17 to 68, with higher scores indicating greater kinesiophobia.
Pain Catastrophizing Scale (PCS)
Time frame: Baseline and 4 weeks
Pain Catastrophizing Scale (PCS) assesses catastrophic thinking related to pain. The scale consists of 13 items scored on a 0-4 Likert scale and provides Rumination, Magnification, Helplessness, and Total scores. Higher scores indicate greater pain catastrophizing.

1 secondary outcome

Pain Intensity - Visual Analog Scale (VAS)
Time frame: Baseline and 4 weeks

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 1 Sep 2026.
Derived from this study: PubMed 42832343Bayraktar EE, Alaca N, Cavusoglu I, Ildeniz Y, Kocak A. Responsiveness and minimal important change of Turkish pain-related psychological measures in chronic non-specific low back pain. Ann Med. 2026 Dec;58(1):2725978. doi: 10.1080/07853890.2026.2725978. Epub 2026 Oct 5.
Individual participant dataSharing planned: No. Individual participant data will not be publicly shared due to privacy and ethical restrictions. De-identified data may be available from the corresponding author upon reasonable request and subject to applicable ethical and institutional requirements.

Related trials for Chronic Low-back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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 University

Irmak Çavuşoğlu, asst. prof. study chair

Kırklareli University

Nuray Alaca, assoc. prof. study director

Acibadem University

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 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 5 inclusion and 9 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 1 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?

Fear-Avoidance Beliefs Questionnaire (FABQ) (time frame: Baseline and 4 weeks). The study lists 3 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 NCT06271447, 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 1 Sep 2026.