The Prognostic Role of Central Sensitization in Short-Term Clinical Outcomes in Chronic Nonspecific Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Clinically Meaningful Improvement in the Oswestry Disability Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Chronic Nonspecific Low Back Pain Cohort
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.
结局指标
主要结局
Clinically Meaningful Improvement in the Oswestry Disability Index
时间窗: 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.
次要结局
- Change in the Oswestry Disability Index Score(Baseline to 6 weeks)
- Change in Pain Intensity(Baseline to 6 weeks)
- Patient-Perceived Improvement(At 6 weeks)
研究者
Hatice Gözde Sümer
M.D.
Mardin Artuklu University