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New Educational Tool for FM

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ClinicalTrials.gov Identifier: NCT04571853
Recruitment Status : Recruiting
First Posted : October 1, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
University of South Australia
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:
This study aims at analyzing the usefulness of a new educational tool developed by Pain Revolution, a compendium of 9 fact sheets along with a related quiz in patients from the Hospital Vall d'Hebron of Barcelona suffering from fibromyalgia, compared to a non-education group. The present study also aims at comparing the usefulness of the new tool based on PNE in two different formats: read and explained.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: PNE-explained group Behavioral: PNE-read group Behavioral: TAU group Not Applicable

Detailed Description:

Main objective

A compendium of 9 fact sheets along with a related quiz have been developed in order to provide overall population current pain-science knowledge. The present study aims at analyzing the usefulness of this new tool based on pain neuroscience education (PNE) in patients from the Hospital Vall d'Hebron of Barcelona suffering from fibromyalgia, compared to a non-education group.

Secondary objective

Due to the extended content of the fact sheets, these can be delivered to the patient as a reading material or can be used as a support material in a educational presentation. Therefore, this study also aims at comparing the usefulness of the new tool based on PNE in two different formats: read autonomously by the patient and explained by a pain-science expert to the patient.

This is a tree-arm RCT: TAU group and intervention group with 2 different groups as follows:

The intervention program is divided in two groups. Both groups will be provided with the PNE fact sheets but in different format (read and explained) and will be given one week to comprehend the content before to assess their knowledge. Therefore, intervention groups will be informed that a quiz about the fact sheets will be delivered to each one in order to asses their acquired knowledge.

There are 9 fact sheets overall. And each fact sheet incorporates two pages relating to one main concept. The first of two pages introduces the concept, and the second one quotes important ideas that emerge from the main concept. The 9 main concepts and consequent ideas presented in the fact sheets are based on current scientific research in pain science and have been selected and structured specifically for PNE education for chronic pain patients. The fact sheets have been fully developed and designed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Usefulness of a New Educational Tool for Understanding Pain for Fibromyalgia Patients
Actual Study Start Date : September 21, 2020
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : October 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: PNE-explained group
The participants in the PNE-explained group will be explained the fact sheets with an explanatory video (due to COVID-19 circumstances) conducted by the therapist M.S. The video will last one hour approximately and it contains a presentation by Mayte Serrat with a view of the fact sheets. This group will be given one week to watch the video and comprehend its content.
Behavioral: PNE-explained group
There are 9 fact sheets overall. And each fact sheet incorporates two pages relating to one main concept. The first of two pages introduces the concept, and the second one quotes important ideas that emerge from the main concept. The 9 main concepts and consequent ideas presented in the fact sheets are based on current scientific research in pain science and have been selected and structured specifically for PNE education for chronic pain patients. The fact sheets have been fully developed and designed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia.

Active Comparator: PNE-read group
The PNE-read group will receive the fact sheets via email along with instructions regarding the content and the procedure to read the content. Instructions will suggest to read only two fact sheets per day during 4,5 days. It will be suggested to take 30 minutes at least for each fact sheet.
Behavioral: PNE-read group
The PNE-read group will receive the fact sheets via email along with instructions regarding the content and the procedure to read the content. Instructions will suggest to read only two fact sheets per day during 4,5 days. It will be suggested to take 30 minutes at least for each fact sheet.

Active Comparator: TAU group
Participants allocated into this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professional.
Behavioral: TAU group
Participants allocated to this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professiona




Primary Outcome Measures :
  1. Pain Revolution Quiz [ Time Frame: Through study completion, an average of 1 week] ]
    The Pain Revolution Quiz comprises two main sections: one first section related to the acquired knowledge after the fact sheets and the second section incorporates 4 questions with feedback about the learning process. The first section encompasses 26 items which are used to measure acquired knowledge by the subjects after being provided the 9 fact sheets content. The 26 items are answered on multicomponent choices of three possible alternatives: true, false and I don't know. Total scores can range from 0 to 26. Some of the items respond to reverse score, such as 1, 5, 7, 8, 10, 12, 14, 20, 22, 25, 26. This tool has been recently developed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia. The adequate internal consistency and acceptable test-retest reliability is currently being studied. In the same manner, the Spanish version is evaluated for first time in the present study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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): NCT04571853


Contacts
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Contact: Mayte Serrat, MSc +34934893891 ext 6644 mserrat@vhebron.net
Contact: Elena Granell +34934893891 elena.granell@vhir.org

Locations
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Spain
Mayte Serrat Recruiting
Barcelona, Spain, 08023
Contact: Mayte Serrat, MSc    +34934893891 ext 6644    mserrat@vhebron.net   
Contact    +34934893891    elena.granell@vhir.org   
Principal Investigator: Lorimer Moseley, PhD         
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
University of South Australia
Investigators
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Principal Investigator: Lorimer Moseley, PhD University of South Australia
Study Director: Sara Marsall, PhD Hospital Universitari Vall dHebron
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Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04571853    
Other Study ID Numbers: NEW EDUCATION TOOL
First Posted: October 1, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Fibromyalgia
Pain Neuroscience Education
Pain
Fact Sheets
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases