Chronic Nonspecific Low Back PainNCT06271460
Responsiveness of Turkish Disability Questionnaires in Chronic Non-Specific Low Back Pain
An observational study of Chronic Nonspecific Low Back Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Standardized Physiotherapy Program
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 27 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Acıbadem Health Group
Istanbul, None Selected, 34752
About this study
Official 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
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.
Read the 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.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Standardized Physiotherapy Program
- Keywords
- chronic low back pain, disability, responsiveness, minimal important change, patient-reported outcome measures, outcome assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized Physiotherapy ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standardized Physiotherapy Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 4 weeks
Secondary outcomes (1)
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.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific Low Back PainStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elif E Bayraktar, asst. prof., Principal investigator, Acibadem UniversityIrmak Çavuşoğlu, asst. prof., Study chair, Kırklareli UniversityNuray Alaca, assoc. prof., Study director, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271460
- Sponsor's protocol ID
- 2023-21-728
- Status last verified
- Aug 2026
- First submitted
- 14 Feb 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06271460
- Acronym / sponsor ID
- 2023-21-728
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- chronic low back pain, disability, responsiveness, minimal important change, patient-reported outcome measures, outcome assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Non-Specific Low Back Pain Cohort | – | Other: Standardized Physiotherapy ProgramAdults 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized Physiotherapy ProgramParticipants 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. | Other | Chronic Non-Specific Low Back Pain Cohort |
Primary outcome
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.
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.
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.
1 secondary outcome
Visual Analog Scale (VAS) for Pain Intensity
Time frame: Baseline and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elif E Bayraktar, asst. prof. principal investigator
Acibadem University
Irmak Çavuşoğlu, asst. prof. study chair
Kırklareli University
Nuray Alaca, assoc. prof. study director
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Nonspecific Low Back Pain, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland-Morris Disability Questionnaire (RMDQ) (time frame: Baseline and 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.