The Influence of a Biopsychosocial Educational Internet-based Intervention on Pain, Dysfunction, Quality of Life, and Pain Cognition in Chronic Low Back Pain Patients in Primary Care: a Mixed Methods Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Kinesiophobia
研究概览
简要总结
Aim: The aim of this project is to identify chronic low back pain patients´ beliefs about the origin and meaning of pain for developing a biopsychosocial web-based educational intervention. The other aim of this project is to assess the effectiveness of this web-based educational intervention for chronic low back pain patients on pain cognitions, pain intensity, and disability.
Methods: Mixed methods design, combining both qualitative and quantitative methodologies. For the qualitative part of this study, the investigators will use qualitative in-depth semi-structured interviews. For the quantitative phase we will use an experimental study design.
Subjects: Chronic low back pain patients between 18-65 years old, attending a primary care setting in the city of Lleida.
Expected outcomes: The investigators expect to change and modify chronic low back pain patients´ cognition by using our web-site educational intervention, with the further outcome of reducing pain and disability.
详细描述
Hypothesis and outcomes
Hypothesis:
- Persistent chronic low back pain and its consequences are maintained by the lack of understanding about the origin and meaning of pain.
- Pain neurophysiology as an educational internet- based intervention for chronic low back pain will change cognition about the origin and meaning of pain, with the outcome of pain reduction, disability reduction, and better quality of life compared to normal care.
Outcomes:
There are specific objectives for each phase of the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of CLBP longer than 6 months.
- •Patients between 20-65 years old.
- •To be able to read, speak and understand Spanish, Catalan, or English.
- •With access to the Internet, a computer or laptop and e-mail address.
- •To accept and sign the informed consent.
排除标准
- •Any red flag condition:
- •Onset age < 20 or > 55 years
- •Non-mechanical pain (unrelated to time or activity)
- •Thoracic pain
- •Previous history of carcinoma, steroids, HIV
- •Feeling unwell
- •Weight loss
- •Widespread neurological symptoms
- •Structural spinal deformity
研究组 & 干预措施
Normal care by GP
Control group: Will follow conventional treatment provided by the family physician in primary care. This treatment is based on the clinical guidelines of the "Institut Català de la Salut" (http://www.gencat.cat/ics/professionals/guies/docs/guia_lumbalgies.pdf).
干预措施: Normal care by GP (Other)
Educational intervention using a website
This group of subjects will be given access to our web-site in where they will find information related to CLBP. This information will be provided in different formats: explanatory video by the author, animated video about the neurophysiology of pain, written format using metaphors, and FAQs. All this information will be based on the information provided by the subjects on QUAL. The aim of this educational intervention is to change patient´s misbeliefs about CLBP with the last outcome of reducing pain intensity, improving function, and reducing disability.
干预措施: Educational intervention (Other)
结局指标
主要结局
Kinesiophobia
时间窗: 2 weeks
This scale is widely used in pain medicine for assessing pain-related fear. The Spanish format has 11 items, with each scoring ranging from 1 (totally disagree) to 4 (totally agree). The Spanish version of the TSK is easy to use, reliable and valid
Pain intensity
时间窗: 2 weeks
This scale was developed by Huskinson in 1976 as a method of measuring pain intensity. VAS is an easy, simple and reproductible tool that can be used by the same patient in multiple occasions. The scale consists on a 10-cm line with a description on both extremes. In the far left "no pain", and "worst pain ever" in the far right of the scale. For some authors VAS is the most sensitive measure in clinical pain research
Fear Avoidance Beliefs
时间窗: 2 weeks
The FABQ is a self-reported questionnaire that consists of 16 items about the beliefs of LBP patients on the influence that physical activity and work have on their pain. Each item can be scored from 0 (totally agree) to 6 (totally disagree). The Spanish version of the FABQ has demonstrated good reliability
次要结局
- Disability(2 weeks)
研究者
Francesc Valenzuela Pascual
Principal investigator
Universitat de Lleida