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Completed

NCT Number: NCT06271460

Responsiveness of Turkish Disability Questionnaires in Chronic Non-Specific Low Back Pain

This prospective observational clinimetric study aimed to compare the responsiveness of the Turkish versions of the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS) in adults with chronic non-specific low back pain. The study also aimed to estimate minimal important change (MIC) values for these instruments using a Global Perceived Effect (GPE) scale as an external anchor and to interpret the MIC estimates in relation to measurement error.

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Key information

Conditions

Chronic Nonspecific Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Acıbadem Health Group

Istanbul, None Selected, 34752, Turkey (Türkiye)

About this study

Chronic non-specific low back pain is commonly associated with limitations in physical functioning and disability. Patient-reported outcome measures such as the Roland-Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI), and Quebec Back Pain Disability Scale (QBPDS) are widely used to assess disability in individuals with low back pain. However, the ability of these instruments to detect clinically meaningful change may differ across populations and cultural settings.

This prospective observational clinimetric study evaluated the responsiveness and clinical interpretability of the Turkish versions of the RMDQ, ODI, and QBPDS in adults with chronic non-specific low back pain. Participants were assessed at baseline and after completion of a standardized four-week physiotherapy program. Responsiveness was evaluated using distribution-based and anchor-based approaches, including effect size, standardized response mean, correlations between change scores and a Global Perceived Effect (GPE) scale, and receiver operating characteristic (ROC) curve analysis.

Minimal important change (MIC) values were estimated using the GPE scale as an external anchor and ROC analysis. Measurement error was also examined using the standard error of measurement (SEM) and minimal detectable change at the 95% confidence level (MDC95), allowing the MIC estimates to be interpreted in relation to measurement precision.

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 of at least 12 weeks' duration
  • Low back pain not attributable to a specific spinal pathology
  • Ability to read and understand Turkish
  • Referral for physiotherapy
  • Provision of written informed consent

Exclusion criteria

  • Previous lumbar spine surgery
  • Specific spinal pathology or progressive neurological deficits
  • Systemic inflammatory or neurological disease
  • Myocardial infarction or cerebrovascular event within the previous 12 weeks
  • Cognitive impairment (Mini-Mental State Examination score <24)
  • Pregnancy
  • Recent intramuscular analgesic injection
  • Participation in structured exercise therapy during the previous 6 months

Treatment and study plan

Standardized Physiotherapy Program

Other

Participants received a standardized physiotherapy program reflecting routine clinical practice, consisting of 16 supervised sessions delivered over four weeks (four sessions per week; approximately 60 minutes per session). The program included lumbar stabilization exercises, trunk strengthening, lower-limb flexibility training, and postural education. Adjunctive electrotherapy was applied when clinically indicated and included superficial heat, conventional transcutaneous electrical nerve stimulation (TENS), and therapeutic ultrasound. All sessions were delivered by licensed physiotherapists according to a standardized treatment protocol. The physiotherapy program served as a change-inducing clinical context for the clinimetric evaluation rather than as an intervention for comparative efficacy testing.

Primary outcomes

  1. Roland-Morris Disability Questionnaire (RMDQ)

    Time frame: Baseline and 4 weeks

    Functional disability related to low back pain was assessed using the Turkish version of the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ consists of 24 dichotomous items scored as 0 or 1, yielding a total score from 0 to 24. Higher scores indicate greater disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

  2. Quebec Back Pain Disability Scale (QBPDS)

    Time frame: Baseline and 4 weeks

    Functional disability related to low back pain was assessed using the Turkish version of the Quebec Back Pain Disability Scale (QBPDS). The QBPDS consists of 20 items assessing limitations in activities involving spinal movement and load transfer. Each item is rated from 0 to 5, yielding a total score from 0 to 100. Higher scores indicate greater functional disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

  3. Oswestry Disability Index (ODI)

    Time frame: Baseline and 4 weeks

    Functional disability related to low back pain was assessed using the Turkish version of the Oswestry Disability Index (ODI). The ODI consists of 10 sections assessing pain intensity and limitations in activities such as personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and sexual activity. Each section is scored from 0 to 5, and the total score is expressed as a percentage from 0% to 100%, with higher scores indicating greater disability. Change scores were calculated as the 4-week follow-up score minus the baseline score, with negative change scores indicating improvement.

Secondary outcomes

  1. Visual Analog Scale (VAS) for Pain Intensity

    Time frame: Baseline and 4 weeks

    Current pain intensity was assessed using a 10-cm Visual Analog Scale (VAS), anchored by 0 ("no pain") and 10 ("worst imaginable pain"). Participants marked their current pain intensity on the line, and the distance from the 0 anchor was measured in centimeters. Higher scores indicate greater pain intensity.

Other outcomes

  1. Global Perceived Effect (GPE) Scale

    Time frame: 4 weeks

    Perceived change in overall condition was assessed at the 4-week follow-up using a 7-point Global Perceived Effect (GPE) scale ranging from "much worse" to "much improved." The GPE was used as an external anchor for responsiveness and minimal important change analyses. For anchor-based analyses, participants reporting "improved" or "much improved" were classified as improved, and all other participants were classified as not improved. Participants reporting "no change" were considered stable for reliability analyses.

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Registry information

Official study title

Responsiveness and Minimal Important Change of the Turkish Versions of the Roland-Morris Disability Questionnaire, Oswestry Disability Index, and Quebec Back Pain Disability Scale in Chronic Non-Specific Low Back Pain: A Prospective Clinimetric Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2024
Registry last updated
Sep 2, 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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