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临床试验/NCT05697848
NCT05697848已完成不适用

Pain Education: Treatment of Patients Affected by Chronic Low Back Pain, Randomized Controlled Study

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
PCS

研究概览

简要总结

The Pain Neuroscience Education (PNE) aims to reconceptualize pain from a marker of tissue damage to a marker of the perceived need to protect body tissue.

The purpose of this study is to verify the long-term efficacy (6 months) of a Pain Education treatment in patients with chronic low back pain, compared to a conventional treatment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

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

  • Age over 18
  • Patients with low back pain of musculoskeletal origin for at least 3 months
  • Patients free from NSAID and/or opioid analgesic therapy for at least 1 month
  • Years of education: over 13
  • Italian mother-tongue

排除标准

  • Presence of neurological symptoms on provocative tests
  • Recent surgical procedure
  • Patients suffering from fibromyalgia or other rheumatological pathology
  • Psychiatric pathologies

结局指标

主要结局

PCS

时间窗: 6 months

Pain Catastrophizing Scale. Score ranges from 0 to 52. Higher scores are associated with higher amounts of pain catastrophizing.

NRS

时间窗: 6 months

Numeric Rating Scale. Score ranges from 0 (no pain) to 10 (the worst pain ever possible)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Gallotta

Physiotherapist

Istituti Clinici Scientifici Maugeri SpA

研究点 (1)

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