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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Nonspecific Low Back Pain
• Intervention / Treatment: Other: Standardized Physiotherapy Program

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • None Selected
    • Istanbul, None Selected, Turkey (Türkiye), 34752
      • Acıbadem Health Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 18-65 years with chronic non-specific low back pain of at least 12 weeks' duration were consecutively recruited from patients referred for physiotherapy in the outpatient Department of Physical Medicine and Rehabilitation of a tertiary-care hospital in Istanbul, Türkiye. Chronic non-specific low back pain was defined as low back pain not attributable to a specific spinal pathology such as fracture, tumor, infection, inflammatory disease, or radiculopathy.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Chronic Non-Specific Low Back Pain Cohort; Adults with chronic non-specific low back pain who were consecutively recruited from patients referred for physiotherapy. Participants were assessed at baseline and after completion of a four-week physiotherapy program to evaluate the responsiveness and minimal important change of the Turkish versions of the RMDQ, ODI, and QBPDS.

Other: Standardized Physiotherapy Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris Disability Questionnaire (RMDQ)	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.	Baseline and 4 weeks
Quebec Back Pain Disability Scale (QBPDS)	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.	Baseline and 4 weeks
Oswestry Disability Index (ODI)	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.	Baseline and 4 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Perceived Effect (GPE) Scale	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.	4 weeks

Collaborators and Investigators

• Sponsor: Acibadem University
• 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 record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): June 27, 2025

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 2, 2026
• Last Update Submitted That Met QC Criteria: August 31, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: chronic low back pain; disability; outcome assessment; responsiveness; patient-reported outcome measures; minimal important change
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2023-21-728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO