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CompletedNCT03301428Updated Mar 25, 2020

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

An interventional study of Retrain pain educational website and Booklet in Beliefs and Disability Physical, sponsored by University of Liege. Completed at 1 site in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-03-25.

Sponsored by University of Liege · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Beliefs
  • Disability Physical
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
300 participants (actual)

Study arms

  • 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

  • Experimental
    Booklet

    Participants will be invited to read an educational booklet for patients with chronic pain

    Other: Booklet

  • No intervention
    Control

    Participants in this group will receive the 2 educational tools at the end of the study

Interventions

  • OtherRetrain pain educational website

    Patients in this group will be invited to consult an educational website developped for patients with chronic pain

  • OtherBooklet

    Patients in this group will be invited toread an educational booklet developped for patients with chronic pain

05

What researchers measure

Primary outcomes

  1. Pain Beliefs Questionnaire

    Questionnaires to test patients' beliefs

    Time frame: Change from baseline to the three-month follow-up

  2. Roland-Morris Disability Questionnaire

    Disability questionnaire

    Time frame: Change from baseline to the three-month follow-up

Secondary outcomes

  1. Brief-Illness Perception Questionnaire

    Questionnaire about patients' beliefs/representations

    Time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up

  2. Back-PAQ questionnaire

    Questionnaire about patients' beliefs

    Time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up

  3. Pain intensity

    Pain Numeric rating scale

    Time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up

06

Study locations

1 site
  • Liege University Hospital
    Liège, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03301428
Lead sponsor
University of Liege
Responsible party
Christophe Demoulin (Invited Professor, University of Liege) — Principal investigator
First posted
Oct 4, 2017
Start date
Nov 1, 2017
Primary completion
May 1, 2019
Completion
Feb 1, 2020
Last update
Mar 25, 2020

Study contacts

Christophe Demoulin
principal investigator · Liege University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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