BeliefsNCT03301428
Educational Tools to Improve Beliefs About Pain and Reduce Pain-related Disability
A study testing Retrain pain educational website and Booklet in people with Beliefs and Disability Physical, run by University of Liege at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Beliefs, Disability Physical
- What is being tested?
- Retrain pain educational website and Booklet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2017to 1 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Beliefs, Disability Physical
- Being tested
- Retrain pain educational website, Booklet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrain pain educational websiteOther
Patients in this group will be invited to consult an educational website developped for patients with chronic pain
BookletOther
Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
| Study group | Role | What they receive |
|---|---|---|
| Retrain pain educational website | Experimental | Participants will be invited to consult an educational website developped for patients with chronic pain Receives: Other: Retrain pain educational website |
| Booklet | Experimental | Participants will be invited to read an educational booklet for patients with chronic pain Receives: Other: Booklet |
| Control | No intervention | Participants in this group will receive the 2 educational tools at the end of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Beliefs Questionnaire
Questionnaires to test patients' beliefs
Measured: Change from baseline to the three-month follow-up
Roland-Morris Disability Questionnaire
Disability questionnaire
Measured: Change from baseline to the three-month follow-up
Secondary outcomes (3)
Brief-Illness Perception Questionnaire
Questionnaire about patients' beliefs/representations
Measured: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Back-PAQ questionnaire
Questionnaire about patients' beliefs
Measured: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Pain intensity
Pain Numeric rating scale
Measured: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Nov 2017
- Primary completion1 May 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BeliefsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christophe Demoulin, University of Liege
- Investigators
- Christophe Demoulin, Principal investigator, Liege University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301428
- Sponsor's protocol ID
- CLBP EDUC
- Status last verified
- Mar 2020
- First submitted
- 1 Sep 2017
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03301428
- Acronym / sponsor ID
- CLBP EDUC
- Conditions
- Beliefs, Disability Physical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Retrain pain educational website | Experimental | Other: Retrain pain educational websiteParticipants will be invited to consult an educational website developped for patients with chronic pain |
| Booklet | Experimental | Other: BookletParticipants will be invited to read an educational booklet for patients with chronic pain |
| Control | No intervention | –Participants in this group will receive the 2 educational tools at the end of the study |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Retrain pain educational websitePatients in this group will be invited to consult an educational website developped for patients with chronic pain | Other | Retrain pain educational website |
| BookletPatients in this group will be invited toread an educational booklet developped for patients with chronic pain | Other | Booklet |
Primary outcome
Pain Beliefs Questionnaire
Time frame: Change from baseline to the three-month follow-up
Questionnaires to test patients' beliefs
Roland-Morris Disability Questionnaire
Time frame: Change from baseline to the three-month follow-up
Disability questionnaire
3 secondary outcomes
Brief-Illness Perception Questionnaire
Time frame: 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
Pain intensity
Time frame: Baseline, one month after receiving the tool, one-month follow-up and three-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Demoulin principal investigator
Liege University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Retrain pain educational website and Booklet in people with Beliefs and Disability Physical, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Beliefs Questionnaire (time frame: Change from baseline to the three-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.