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临床试验/NCT07001982
NCT07001982已完成不适用

The Relationship Central Sensitization, Pain and Depression Patients With Lumbar Spinal Stenosis

Karabuk University2 个研究点 分布在 2 个国家目标入组 81 人开始时间: 2025年6月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
81
试验地点
2
主要终点
Disability levels

研究概览

简要总结

Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. Pain is, therefore, an important problem for patients. Pain lasts for years in LSS and thus becomes chronically persistent. As a result, persistent pain can cause sensitization due to a decrease in the pain threshold. This condition affects patients not only biomedically but also biopsychosocially. For this reason, various sleep disorders and mood disorders can develop in patients. Therefore, this study aimed to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.

详细描述

Lumbar spinal stenosis (LSS) functionally limits individuals by causing pain in both the waist and the legs during activity and walking. In particular, the pain in LSS lasts for years and becomes chronic and can cause persistent and disturbing sensitization. This situation may be associated with decreased pain threshold and allodynia. Various studies show that sensitization can affect individuals biomedically and may lead to important health problems. Some of these are sleep and depression problems. Sleep and a healthy mentality are important for continuing daily activities and preserving quality of life. However, when the literature is examined, it is seen that central sensitization and the parameters that may be related to this have not been examined sufficiently. Therefore, the aim of this study is to examine the relationship between central sensitization and pain, disability, sleep and depression in patients with LSS.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with lumbar spinal stenosis by MRI,
  • The ages of 45-80,
  • Low back and/or leg pain that has persisted for at least 3 months
  • Volunteer to participate in the study

排除标准

  • Patients who did not agree to participate in the study,
  • Those with a history of serious neurological diseases such as Parkinson's, hemiplegia, multiple sclerosis,
  • Those who had undergone surgery in the lumbar region within the last year,
  • Those with advanced joint disease in the lower extremity,
  • Those with malignancy in the spine,
  • Those who had a previous operation for the lower extremity,
  • Those who had a pain or disability in other musculoskeletal joints,
  • Those who had a psychological disorder or peripheral vascular disease
  • Those who had any concurrent serious medical condition, including sepsis or cancer
  • Those who did not cooperate well were not included in the study.

研究组 & 干预措施

Patients with central sensitization with LSS

Patients with lumbar spinal stenosis with high sensitization will be included.

Normal sensitization patients with LSS

Patients with lumbar spinal stenosis with normal sensitization will be included.

结局指标

主要结局

Disability levels

时间窗: Baseline

Disability will be measured by the Oswestry Disability Index. The total score ranges from 0-100 and the higher the score, the higher the level of disability.

Pain catastrophizing

时间窗: Baseline

It will be evaluated using the pain catastrophizing scale. The total score varies between 0-52. As the score increases, negative feelings and thoughts increase.

Sleep quality

时间窗: Baseline

Sleep quality will be assessed with the Pittsburgh Sleep Quality Index. It is scored from 0 to 21, with higher scores indicating worse sleep quality.

Depression

时间窗: Baseline

The Center for Epidemiological Studies Depression Scale (CES-D) will be used to assess depression.The total score is 0-60. As the score increases, depression increases.

Central sensitization

时间窗: Baseline

Central sensitization will be assessed with the "Central Sensitization Scale". The total score range is between 0-100 points. As the score increases, sensitization increases and 40 points and above are considered higher sensitization.

Pain severity

时间窗: Baseline

Pain intensity will be assessed with Numeric Rating Scale (NRS). NRS varies between 0-10 and the higher the score, the greater the pain.

Pain pressure threshold

时间窗: Baseline

Pressure pain threshold will be measured with an algometer in kg. High values indicate a high pain threshold.

次要结局

未报告次要终点

研究者

发起方
Karabuk University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Musa Güneş

Principal Investigator, PhD

Karabuk University

研究点 (2)

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