About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Progressive neurological deficit
Inflammatory rheumatic disease
Active malignancy
History of serious spinal trauma or spinal surgery
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Sponsors and contacts
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Mardin Artuklu University
Lead sponsor
Mardin Training and Research Hospital
Collaborator