Efficacy of Multicomponent Treatment for Fibromyalgia (FISIOFM) (FISIOFM)
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|ClinicalTrials.gov Identifier: NCT04284566|
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : February 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: TAU + multicomponent treatment FISIOFM Behavioral: Treatment as Usual (TAU)||Not Applicable|
This is a two-arm RCT focused on the safety and potential efficacy of the multicomponent program FISIOFM as coadjuvant of treatment-as-usual (TAU) vs. TAU alone.
- FISIOFM combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.
- 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 self-efficacy.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Parallel Assignment Single-blind, parallel-group, randomized controlled trial|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Multicomponent Treatment in Patients With Fibromyalgia Based on Pain Neuroscience Education, Therapeutic Exercise, Cognitive Behavioural Therapy, and Mindfulness: A Randomized Controlled Trial (FISIOFM)|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2020|
Experimental: TAU + multicomponent treatment FISIOFM
FISIOFM is a multicomponent non-pharmacological program based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness Training
Behavioral: TAU + multicomponent treatment FISIOFM
Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):
Active Comparator: Treatment as Usual (TAU)
Standard Care. Although there is no treatment considered as the gold standard for fibromyalgia, the standard treatment is usually mainly pharmacological and conforms to the symptomatic profile of each patient.
Behavioral: Treatment as Usual (TAU)
Standard pharmacological treatment usually provided to patients with fibromyalgia.
- Revised Fibromyalgia Impact Questionnaire (FIQR) [ Time Frame: Through study completion, an average of 9 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.
- Tampa Scale for Kinesiophobia (TSK-11) [ Time Frame: Through study completion, an average of 9 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) [ Time Frame: Through study completion, an average of 9 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) [ Time Frame: Through study completion, an average of 9 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284566
|Contact: Mayte Serrat, MSc||+34934893891 ext email@example.com|
|Contact: Elena Granellfirstname.lastname@example.org|
|Study Chair:||Sara Marsal, PhD||Vall d'Hebrón Hospital|