New Educational Tool for FM

September 26, 2020 updated by: Hospital Universitari Vall d'Hebron Research Institute

Usefulness of a New Educational Tool for Understanding Pain for Fibromyalgia Patients

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Mayte Serrat
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lorimer Moseley, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 1 week]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborators

University of South Australia

Investigators

  • Principal Investigator: Lorimer Moseley, PhD, University of South Australia
  • Study Director: Sara Marsall, PhD, Hospital Universitari Vall dHebron

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 21, 2020

Primary Completion (Anticipated)

October 10, 2021

Study Completion (Anticipated)

October 10, 2021

Study Registration Dates

First Submitted

September 26, 2020

First Submitted That Met QC Criteria

September 26, 2020

First Posted (Actual)

October 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 26, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEW EDUCATION TOOL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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