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Completed

NCT Number: NCT06271447

MIC of Turkish Pain-related Psychological Measures

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.

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Key information

Conditions

Chronic Low-back Pain Anxiety Disorders Kinesiophobia Mental Disorders Phobic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Avicenna Ataşehir Hospital

Istanbul, None Selected, 34750, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized Rehabilitation Program

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2024
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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