Effectiveness of Experiential Fibrowalk Therapy for Fibromyalgia Based on Pain Science Education, Exercise Therapy, Psychological Support, and Nature Exposure: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
The present project will evaluate through a randomised controlled clinical trial with 4-month follow-up, the efficacy in clinical symptoms and quality of life (3-month time horizon) of the multicomponent EXPERIENTIAL FIBROWALK programme in treating individuals diagnosed with fibromyalgia, in compare with original Fibrowalk and virtual Fibrowalk. Pre-post changes will be evaluated in various variables under investigation, will include kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity.
The design of the present study with 3 treatment branches:
Condition or disease Fibromyalgia Intervention/treatment Behavioral: TAU + Experiential Fibrowalk Behavioral: TAU + Fibrowalk Behavioral: TAU + virtual
详细描述
The objective of the Experiential Fibrolwalk study is to determine the clinical effectiveness of a new treatment protocol for individuals with fibromyalgia. This protocol was developed by identifying predictors of poor response and through collaboration between physiotherapists, clinical psychologists, and patients. The objectives of this 4-month controlled clinical trial are twofold. Firstly, it aims to assess the impact of a protocol developed collaboratively by clinical therapists and users on the quality of life of individuals with fibromyalgia. Secondly, it aims to determine the pre-post changes in kinesiophobia, physical function, anxiety, depression, physical dysfunction, overall impact, and symptom intensity. Methods and analysis: The study will involve 120 fibromyalgia patients recruited from the Central Sensitivity Syndromes Specialized Unit at Vall d'Hebron Hospital's Rheumatology Service, who will be randomly assigned to one of three study groups: TAU + Experiential Fibrowalk, TAU + Fibrowalk, TAU + virtual. A comprehensive assessment to collect functional impact, depressive-anxiety symptoms, physical function, fatigue, kinesiophobia, pain catastrophism, impression of change,quality of life variables will be conducted pre-intervention, at half of the intervention (6 weeks), post-intervention (12 weeks), and at 3-month follow-up.
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 80 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: Change from baseline values at 3 months
Standard pharmacological treatment usually provided to patients with fibromyalgia. 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
- Hospital Anxiety and Depression Scale (HADS)(Change from baseline values at 3 months)
- Pain Catastrophising Scale (PCS)(Change from baseline values at 3 months)
- Socio-demographic questionnaire(Change from baseline values at 3 months)
- Credibility/Expectancy Questionnaire (CEQ) (Adapted version)(Change from baseline values at 3 months)
- Tampa Scale for kinesiophobia (TSK-11)(Change from baseline values at 3 months)
- Psychological inflexibility in pain scale (PIPS)(Change from baseline values at 3 months)
- Short Form-36 Health Survey (SF-36)(Change from baseline values at 3 months)
- Multidimensional Fatigue Inventory (MFI)(Change from baseline values at 3 months)
- The Patient Global Impression of Change (PGIC)(Change from baseline values at 3 months)
- Pain Specific Impression of Change (PSIC)(Change from baseline values at 3 months)
- Adverse effects of treatments(Change from baseline values at 3 months)