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NCT Number: NCT07826546

Is Central Sensitization a Prognostic Indicator in Chronic Nonspecific Low Back Pain?

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.

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Key information

Conditions

Chronic Nonspecific Low Back Pain

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Mardin Training and Research Hospital

Mardin, 47100, Turkey (Türkiye)

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clinically Meaningful Improvement in the Oswestry Disability Index

    Time frame: 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 outcomes

  1. Change in the Oswestry Disability Index Score

    Time frame: 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.

  2. Change in Pain Intensity

    Time frame: 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.

  3. Patient-Perceived Improvement

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Mardin Artuklu University

Other

Collaborators

  • Mardin Training and Research Hospital

Registry information

Official study title

The Prognostic Role of Central Sensitization in Short-Term Clinical Outcomes in Chronic Nonspecific Low Back Pain

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2026
Registry last updated
Sep 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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