Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability
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
1 other identifier
interventional
300
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2017
CompletedFirst Posted
Study publicly available on registry
October 4, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMarch 25, 2020
March 1, 2020
1.5 years
September 1, 2017
March 24, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Pain Beliefs Questionnaire
Questionnaires to test patients' beliefs
Change from baseline to the three-month follow-up
Roland-Morris Disability Questionnaire
Disability questionnaire
Change from baseline to the three-month follow-up
Secondary Outcomes (3)
Brief-Illness Perception Questionnaire
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Back-PAQ questionnaire
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Pain intensity
Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Study Arms (3)
Retrain pain educational website
EXPERIMENTALParticipants will be invited to consult an educational website developped for patients with chronic pain
Booklet
EXPERIMENTALParticipants will be invited to read an educational booklet for patients with chronic pain
Control
NO INTERVENTIONParticipants in this group will receive the 2 educational tools at the end of the study
Interventions
Patients in this group will be invited to consult an educational website developped for patients with chronic pain
Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liege University Hospital
Liège, Belgium
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe Demoulin
Liege University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Invited Professor
Study Record Dates
First Submitted
September 1, 2017
First Posted
October 4, 2017
Study Start
November 1, 2017
Primary Completion
May 1, 2019
Study Completion
February 1, 2020
Last Updated
March 25, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share