Chronic Nonspecific Low Back Pain
Conditions
Keywords
Central Sensitization, Chronic Low Back Pain, Nonspecific Low Back Pain, Oswestry Disability Index, Prognostic Factor
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Mardin Artuklu University
Mardin Training and Research Hospital
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 to 65 years * Diagnosis of chronic nonspecific low back pain lasting for at least 3 months * Willingness to participate in the study * Ability to provide written informed consent
Exclusion criteria
* Progressive neurological deficit * Inflammatory rheumatic disease * Active malignancy * History of serious spinal trauma or spinal surgery * Cognitive impairment that may prevent completion of the assessments or follow-up * Initiation, dose modification, or change of antidepressant or gabapentinoid treatment within the previous 3 months * Pregnancy, postpartum period, or breastfeeding * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinically Meaningful Improvement in the Oswestry Disability Index | Baseline to 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Oswestry Disability Index Score | Baseline to 6 weeks | 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. |
| Change in Pain Intensity | Baseline to 6 weeks | 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. |
| Patient-Perceived Improvement | At 6 weeks | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTTaha Yasin YILDIRIM, M.D.
CONTACTHatice Gözde Sümer, M.D.
Outcome results
None listed