Chronic Nonspecific Low Back Pain
Conditions
Keywords
chronic low back pain, disability, responsiveness, minimal important change, patient-reported outcome measures, outcome assessment
Brief 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. 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.
Interventions
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.
Sponsors
Acibadem University
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris Disability Questionnaire (RMDQ) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) for Pain Intensity | 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. |
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
Outcome results
None listed