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New Educational Tool for FM

Primary Purpose

Fibromyalgia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PNE-explained group
PNE-read group
TAU group
Sponsored by
Hospital Universitari Vall d'Hebron Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Pain Neuroscience Education, Pain, Fact Sheets

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayte SerratRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

PNE-explained group

PNE-read group

TAU group

Arm Description

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.

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.

Participants allocated into this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professional.

Outcomes

Primary Outcome Measures

Pain Revolution Quiz
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.

Secondary Outcome Measures

Full Information

First Posted
September 26, 2020
Last Updated
September 26, 2020
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
University of South Australia
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1. Study Identification

Unique Protocol Identification Number
NCT04571853
Brief Title
New Educational Tool for FM
Official Title
Usefulness of a New Educational Tool for Understanding Pain for Fibromyalgia Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 21, 2020 (Actual)
Primary Completion Date
October 10, 2021 (Anticipated)
Study Completion Date
October 10, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborators
University of South Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Pain Neuroscience Education, Pain, Fact Sheets

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Single-blind, parallel-group, randomized controlled trial
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PNE-explained group
Arm Type
Experimental
Arm Description
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.
Arm Title
PNE-read group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
TAU group
Arm Type
Active Comparator
Arm Description
Participants allocated into this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professional.
Intervention Type
Behavioral
Intervention Name(s)
PNE-explained group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PNE-read group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TAU group
Intervention Description
Participants allocated to this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professiona
Primary Outcome Measure Information:
Title
Pain Revolution Quiz
Description
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.
Time Frame
Through study completion, an average of 1 week]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mayte Serrat, MSc
Phone
+34934893891
Ext
6644
Email
mserrat@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Elena Granell
Phone
+34934893891
Email
elena.granell@vhir.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorimer Moseley, PhD
Organizational Affiliation
University of South Australia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sara Marsall, PhD
Organizational Affiliation
Hospital Universitari Vall dHebron
Official's Role
Study Director
Facility Information:
Facility Name
Mayte Serrat
City
Barcelona
ZIP/Postal Code
08023
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayte Serrat, MSc
Phone
+34934893891
Ext
6644
Email
mserrat@vhebron.net
Phone
+34934893891
Email
elena.granell@vhir.org
First Name & Middle Initial & Last Name & Degree
Lorimer Moseley, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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New Educational Tool for FM

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