Effectiveness of Two Video-based Multicomponent Treatments for Fibromyalgia: The Added Value of Face-to-face Sesions in a Three-arm Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
The aim of this study was to examine the effectiveness of two video-based multicomponent programs: Fibrowalk Virtual and the Fibrowalk Virtual plus face-to-face sessions for patients with fibromyalgia (FM) compared to treatment-as-usual (TAU) only.
The investigators posit that Fibrowalk Virtual plus face-to-face sessions, due to the best results obtained with the Fibrowalk carried out completely face-to-face versus the results of the Fibrowalk Virtual, can help patients with FM to experience more ubiquitous clinical improvement than TAU or Fibrowalk Virtual alone.
详细描述
Fibrowalk therapy has shown better results when performed in a natural environment face-to-face. Due to the state of the pandemic, it is necessary to study different forms of approach. It is proposed what number of face-to-face sessions would be necessary to add to the virtual Fibrowalk program to achieve the same or similar effectiveness as in the totally face-to-face format.
This is a tree-arm RCT focused on the safety and potential effectiveness of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatmentas- usual (TAU) vs. TAU alone and on the comparation of the FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK.
- VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
- FACE-TO-FACE SESSIONS ADDED TO VIRTUAL FIBROWALK combines de same components than Fibrowalk Virtual and added 4 face-to-face sessions (1 per mounth) to resolve doubts and reinforce the main concepts of therapy.
- The main hypothesis is that improvement on functional impairment of patients with fibromyalgia can be achieved by the direct intervention on mechanisms such as kinesiophobia and fear avoidance
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults from 18 to 75 years-old.
- •1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
- •Able to understand Spanish and accept to participate in the study.
排除标准
- •Participating in concurrent or past RCTs (previous year).
- •Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: Through study completion, an average of 3 months
The FIQR comprises three dimensions: physical dysfunction (scores from 0 to 30), overall impact (scores from 0 to 20), and intensity of the symptoms (scores from 0 to 50) is used to measure the impact generated by FM during the last week. It consists of 21 items, which are answered on a numerical rating scale of 11 points (from 0 to 10). Total scores can range from 0 to 100, with higher scores reflecting greater deterioration.
次要结局
- Visual-analogue scale of perceived pain (VAS-Pain)(Through study completion, an average of 3 months)
- Physical Function of the 36-Item Short Form Survey (SF-36)(Through study completion, an average of 3 months)
- Tampa Scale for Kinesiophobia (TSK-11)(Through study completion, an average of 3 months)
- Hospital Anxiety and Depression Scale (HADS)(Through study completion, an average of 3 months)