跳至主要内容
临床试验/NCT06138158
NCT06138158已完成不适用

Improvement of Fear-avoidance Beliefs in Patients With Chronic Non-specific Low Back Pain Treated at the Non-specific Low Back Pain Treated in the Back School

University of Las Palmas de Gran Canaria2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2023年11月11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
39
试验地点
2
主要终点
Changes in the level of fear-avoidance beliefs.

研究概览

简要总结

Non-specific chronic low back pain is the main cause of public spending on health care and labor, with a prevalence of 10.2%. Its therapeutic management is difficult, with moderate levels of pain and persistent disability over time, influenced by psychosocial factors, such as "fear-avoidance" beliefs. The supervised therapeutic exercise program associated with an educational component is one of the most effective interventions to reduce pain and disability in these patients, but its efficacy seems to be less if there are erroneous beliefs, avoidance attitudes, or fear of physical activity, since it makes it difficult to follow the recommendations. The Back School would address this problem, seeking to improve pain, disability and increase quality of life.

详细描述

The main objective of this study is to evaluate the influence of the intervention of the Back School of the Hospital Universitario Insular de Gran Canaria in reducing the levels of "fear-avoidance" beliefs in patients with non-specific chronic low back pain.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

入选标准

  • Diagnosis of non-specific low back pain, age 18-65 years, acceptance of voluntary participation and signature of the informed consent document.
  • Acceptance of voluntary participation and signature of the informed consent document.
  • Sufficient oral and written knowledge of the Spanish language
  • Absence of any other educational intervention at the present time.

排除标准

  • Presence or suspicion of red flags
  • Cognitive impairment
  • Spinal surgery
  • Intolerance to physical activity
  • Litigation pending resolution
  • Pregnancy or postpartum less than 6 months
  • Withdrawal from the study (signature of the informed consent revocation document).

结局指标

主要结局

Changes in the level of fear-avoidance beliefs.

时间窗: Baseline and up to ten weeks

This variable will be recorded using the Spanish version of the Fear-Avoidance Belief Questionnaire (FABQ). The FABQ contains 16 items. Each item is answered on a 7-point Likert scale (0 = strongly disagree; 6 = strongly agree). The FABQ-total represents the sum of all items (96 possible points). A higher score indicates more deeply held fear avoidance beliefs. There are two subscales within the FABQ: a subscale of Fear-Avoidance to physical activity, with 5 items (FABQ: items scoring 2, 3, 4 and 5; maximum score, 24), and another of Fear-Avoidance to work, with 11 items (FABQ: items scoring 6, 7, 9, 10, 11, 12 and 15; maximum score, 42). Its Spanish version has shown as good or better properties in the FABQ-total questionnaire than in its subscales to determine Fear-avoidance.

Change in Pain assessed by VAS

时间窗: Baseline and up to ten weeks

The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".

次要结局

  • Change in Sleep quality(Baseline and up to ten weeks)
  • Change in the level of disability(Baseline and up to ten weeks)

研究者

发起方
University of Las Palmas de Gran Canaria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aníbal Báez Suárez

Clinical Professor

University of Las Palmas de Gran Canaria

研究点 (2)

Loading locations...

相似试验