NCT03301428

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

September 1, 2017

Last Update Submit

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

EXPERIMENTAL

Participants will be invited to consult an educational website developped for patients with chronic pain

Other: Retrain pain educational website

Booklet

EXPERIMENTAL

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

Other: Booklet

Control

NO INTERVENTION

Participants 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

Retrain pain educational website
BookletOTHER

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

Booklet

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Christophe Demoulin

    Liege University Hospital

    PRINCIPAL INVESTIGATOR

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

Locations