- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06271447
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
None Selected
-
Istanbul, None Selected, Turkey (Türkiye), 34750
- Avicenna Ataşehir Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
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
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-21-705
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.