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MIC of Turkish Pain-related Psychological Measures

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06271447
Enrollment
124
Registered
2024-02-21
Start date
2024-12-09
Completion date
2026-03-06
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low-back Pain

Keywords

Chronic Low Back Pain, Responsiveness, Fear-Avoidance Beliefs, Kinesiophobia, Pain Catastrophizing, Rehabilitation, Minimal Important Change

Brief 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.

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.

Interventions

OTHERStandardized Rehabilitation Program

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.

Sponsors

Acibadem University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fear-Avoidance Beliefs Questionnaire (FABQ)Baseline and 4 weeksFear-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)Baseline and 4 weeksTampa 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)Baseline and 4 weeksPain 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

MeasureTime frameDescription
Pain Intensity - Visual Analog Scale (VAS)Baseline and 4 weeksVisual 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.

Countries

Turkey (Türkiye)

Contacts

PRINCIPAL_INVESTIGATORElif E Bayraktar, asst. prof.

Acibadem University

STUDY_CHAIRIrmak Çavuşoğlu, asst. prof.

Kırklareli University

STUDY_DIRECTORNuray Alaca, assoc. prof.

Acibadem University

STUDY_CHAIRYağmur İldeniz, MSc

Acibadem University

STUDY_CHAIRAsiye Koçak

Avicenna Ataşehir Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026