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临床试验/NCT07488936
NCT07488936招募中不适用

Effects of Low Back Pain Types on Pain Severity and Quality of Life in Patients With Failed Back Surgery Syndrome

Konya Beyhekim Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Effect of pain types on quality of life in patients with failed back surgery syndrome

研究概览

简要总结

The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.

The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.

Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.

To determine the type of pain:

Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.

For nociplastic pain affecting the musculoskeletal system, a diagnosis of nociplastic pain will be made according to clinical criteria and grading scores.

Those who do not meet these criteria will be classified as having nociceptive pain.

详细描述

The aim of this study is to determine the effects of different types of low back pain on pain intensity and quality of life in patients with failed low back surgery syndrome.

The study will include 200 patients with failed lumbar spine surgery syndrome who present to the physical therapy and rehabilitation (FTR) outpatient clinics of Konya Beyhekim Training and Research Hospital with complaints of lower back pain lasting at least 3 months.

Patients will be evaluated in a single session. The Visual Analog Scale (VAS), Pain Catastrophizing Scale (PCS) will be used to determine the patients' pain level and impact, the Roland-Morris Disability Questionnaire (RMDQ) will be used for functionality assessment, and the SF-36 score will be used for quality of life assessment.

To determine the type of pain:

Those with pain levels above the cutoff value on the DN4 (Douleur Neuropathique 4 Questions) pain scale will be diagnosed with neuropathic pain.

研究设计

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

入排标准

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

入选标准

  • *Being over 18 years of age
  • Being willing to participate in the study
  • Having been diagnosed with failed back surgery syndrome

排除标准

  • *Those under 18 years of age
  • Those with major psychiatric illnesses
  • Those with communication problems
  • Other causes of back pain

结局指标

主要结局

Effect of pain types on quality of life in patients with failed back surgery syndrome

时间窗: Baseline

Quality of life will be assessed using the SF-36 , Pain Catastrophizing Scale-PCS , The Roland-Morris Disability Questionnaire-RMDQ, DN4 (Douleur Neuropathique 4 Questions) Vizüel Analog Scale (VAS) scale and quality of life scores will be compared according to different pain types.

次要结局

未报告次要终点

研究者

发起方
Konya Beyhekim Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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