Fibromyoma;Cervix
Conditions
Keywords
Cost-utility, Fibromyalgia, multicomponent treatment, randomized controlled trial
Brief summary
The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.
Detailed description
This is a two-arm RCT focused on the effectiveness and cost-utility of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) vs. TAU alone (in a 3-month follow-up RCT) VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
Interventions
BEHAVIORALMulticomponent treatment VIRTUAL FIBROWALK + TAU
To assess the effectiveness and cost-utility of the virtual multicomponent program (Fibrowalk)
Sponsors
Universitat Autonoma de Barcelona
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Revised Fibromyalgia Impact Questionnaire (FIQR) | Change from baseline values at 6 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. |
| Client Service Receipt Inventory (CSRI) | Change from baseline values at 6 months | The Client Service Receipt Inventory (CSRI) is a tool used to collect information on the whole range of services and supports study participants may use. This data can be used for a wide range of applications, including estimating the costs of service receipt. |
| EuroQoL questionnaire (EQ-5D-5L) | Change from baseline values at 6 months | The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tampa Scale for Kinesiophobia (TSK-11) | Change from baseline values at 6 months | TSK-11 is used to assess fear of pain and movement. It consists of 11 items, which are answered on a Likert scale of 4 points. Total scores of each scale range from 11 to 44, where higher scores indicate a greater fear of pain and movement. |
| Hospital Anxiety and Depression Scale (HADS) | Change from baseline values at 6 months | HADS is used to quantify the severity of anxiety and depression symptoms. It consists of two dimensions (anxiety and depression) of 7 items each responding on a Likert scale of 4 points. Total scores of each scale (HADS-A and HADSD) range from 0 to 21, where higher scores indicate greater severity of symptoms. |
| Physical Function of the 36-Item Short Form Survey (SF-36) | Change from baseline values at 6 months | Physical Function of the 36-Item Short Form Survey (SF-36) was used to measure physical function.This dimension comprises a total of 10 items, which are answered on a Likert scale of 3 points. Total scores on each scale are then transformed and can range from 0 to 100, with higher scores indicate better physical function. |
Countries
Spain
Outcome results
None listed