An observational study in Chronic Nonspecific Low Back Pain, sponsored by Mardin Artuklu University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Mardin Artuklu University · Observational
This observational study will examine whether signs of increased sensitivity in the nervous system at the beginning of the study are associated with short-term clinical outcomes in adults with chronic nonspecific low back pain. Approximately 180 participants will complete questionnaires about central sensitization, disability, pain, anxiety, and depression at the beginning of the study.
After 6 weeks, disability, pain, and the participant's overall perception of change will be assessed again. The researchers will evaluate whether the initial level of central sensitization is associated with meaningful improvement in disability and perceived treatment benefit. Participants will not be assigned to a treatment as part of this study and will continue to receive routine clinical care.
Background: Chronic nonspecific low back pain may have different clinical outcomes among patients. These differences cannot always be explained by structural findings. Central sensitization may be one of the factors related to treatment outcomes.
Objective: This study aims to investigate whether the baseline Central Sensitization Inventory (CSI) score can predict short-term clinical improvement and perceived treatment benefit in patients with chronic nonspecific low back pain.
Method: This prospective observational study will include 180 adults with chronic nonspecific low back pain. At baseline, the CSI, Oswestry Disability Index (ODI), Visual Analog Scale for pain, and Hospital Anxiety and Depression Scale will be completed. After 6 weeks of routine clinical care, the ODI, pain score, and Global Rating of Change will be evaluated again. A decrease of at least 30% in the ODI score will be accepted as clinically meaningful improvement. The relationship between the baseline CSI score and clinical outcomes at 6 weeks will be analyzed.
Adults aged 18-65 years with chronic nonspecific low back pain lasting for at least 3 months will be recruited from the Physical Medicine and Rehabilitation outpatient clinic of Mardin Training and Research Hospital. Participants will receive routine clinical care and will be evaluated at baseline and after 6 weeks. No healthy control group will be included.
Exclusion Criteria:
Adults aged 18-65 years with chronic nonspecific low back pain will be evaluated at baseline and followed for 6 weeks. Participants will receive routine clinical care determined by their treating physician. No treatment or intervention will be assigned by the study protocol. Baseline central sensitization symptoms will be evaluated in relation to disability, pain, and perceived improvement at 6 weeks.
Clinically Meaningful Improvement in the Oswestry Disability Index
The proportion of participants who achieve a reduction of at least 30% in the Oswestry Disability Index (ODI) score from baseline. The ODI ranges from 0 to 100, with higher scores indicating greater disability.
Time frame: Baseline to 6 weeks
Change in the Oswestry Disability Index Score
Change in the Oswestry Disability Index (ODI) score from baseline to 6 weeks. The ODI ranges from 0 to 100, with higher scores indicating greater disability. A greater reduction indicates greater improvement in disability.
Time frame: Baseline to 6 weeks
Change in Pain Intensity
Change in pain intensity measured using a 0-10 Visual Analog Scale from baseline to 6 weeks. A score of 0 indicates no pain, and a score of 10 indicates the worst possible pain. A greater reduction indicates greater improvement in pain.
Time frame: Baseline to 6 weeks
Patient-Perceived Improvement
Patient-perceived change in overall clinical status will be assessed using the Global Rating of Change scale at 6 weeks. Participants will report whether their condition has improved, remained unchanged, or worsened compared with baseline. The responses will be classified as perceived treatment benefit or no perceived treatment benefit according to the prespecified study criteria.
Time frame: At 6 weeks
Plan to share: No
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Mardin Artuklu University