Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability

March 24, 2020 updated by: Christophe Demoulin, University of Liege

Effectiveness of Different Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability in Patients With Chronic Low Back Pain: a Randomized Controlled Trial

This trial aims at comparing the effectiveness of different didactic tools developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This trial aims at comparing the effectiveness of different didactic tools (an educational website vs a booklet) developed for patients with chronic pain to correct misbeliefs and improve disability in patients with chronic low back pain.

Participants of the 2 experimental groups will be invited to use the tool they receive during a one-month period.

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Belgium
      • Liège, Belgium
        • Liege University Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • individuals with non-specific persistent low back pain (pain > 6 months) who had their pain assessed by their general practitioner or a specialist within the last 3 months

Exclusion Criteria:

  • specific low back pain,
  • educational treatment (back school, cognitive-behavioral, pain neurosciences education) in progress or planned during the study period
  • previous consultation of the didactic tools investigated in the present study
  • nerve root compromise,
  • recent spinal surgery (<3 months)
  • not fluent in French
  • no regular access to a computer and the internet
  • present follow-up by a psychiatrist

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Retrain pain educational website
Participants will be invited to consult an educational website developped for patients with chronic pain
Other: Retrain pain educational website
Patients in this group will be invited to consult an educational website developped for patients with chronic pain
Experimental: Booklet
Participants will be invited to read an educational booklet for patients with chronic pain
Other: Booklet
Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
No Intervention: Control
Participants in this group will receive the 2 educational tools at the end of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Beliefs Questionnaire
Time Frame: Change from baseline to the three-month follow-up
Questionnaires to test patients' beliefs
Change from baseline to the three-month follow-up
Roland-Morris Disability Questionnaire
Time Frame: Change from baseline to the three-month follow-up
Disability questionnaire
Change from baseline to the three-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief-Illness Perception Questionnaire
Time Frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Questionnaire about patients' beliefs/representations
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Back-PAQ questionnaire
Time Frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Questionnaire about patients' beliefs
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Pain intensity
Time Frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Pain Numeric rating scale
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up

Collaborators and Investigators

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

Sponsor

University of Liege

Investigators

  • Principal Investigator: Christophe Demoulin, Liege University Hospital

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)

November 1, 2017

Primary Completion (Actual)

May 1, 2019

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

September 1, 2017

First Submitted That Met QC Criteria

September 28, 2017

First Posted (Actual)

October 4, 2017

Study Record Updates

Last Update Posted (Actual)

March 25, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CLBP EDUC

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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