MIC of Turkish Pain-related Psychological Measures

August 31, 2026 updated by: Acibadem University

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • None Selected
      • Istanbul, None Selected, Turkey (Türkiye), 34750
        • Avicenna Ataşehir Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks
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.
Baseline and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity - Visual Analog Scale (VAS)
Time Frame: Baseline and 4 weeks
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.
Baseline and 4 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Rating of Change (GRC)
Time Frame: 4 weeks
Global Rating of Change (GRC) assesses the participant's perceived overall change in condition relative to treatment start. It is rated on a 7-point scale from 1 ("no change or worse") to 7 ("much better, a significant improvement"). Scores of 6-7 were classified as improved and scores of 3-5 as not improved.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Elif E Bayraktar, asst. prof., Acibadem University
  • Study Chair: Irmak Çavuşoğlu, asst. prof., Kırklareli University
  • Study Director: Nuray Alaca, assoc. prof., Acibadem University
  • Study Chair: Yağmur İldeniz, MSc, Acibadem University
  • Study Chair: Asiye Koçak, Avicenna Ataşehir Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Actual)

March 6, 2026

Study Completion (Actual)

March 6, 2026

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Actual)

February 21, 2024

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 31, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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