Non-specific Low Back PainVRRPFNCT01918228
Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year.
A study testing Talks about what science says about LBP in people with Non-specific Low Back Pain, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour. Read more about this study
- Who is it for?
- Ages 18 to 72 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- Talks about what science says about LBP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2013to Apr 2016
- 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 72 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -employed at one of the participating municipal workplaces
Who cannot join
- pregnancy within the first 6 months of the study
- physical or mental disease that has significant impact on the individual in terms of pain (eg. Rheumathoid disease, clinical depression)
- present cancer disease (risk of metastasis)
- planned stop at the workplace within the first 6 months of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.
RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour.
Read the detailed description
Previous studies have strongly implied that information is a valuable means for people suffering from LBP in terms of coping appropriately. Most studies have tested the effect of information as part of a multimodal intervention.
Four Nordic studies testing the effect of 'reassuring information' based on the 'Functional Disturbance'-model (proposed by Indahl et al. 1999 - also called the 'non-injury'-model) have all been effective at positively altering the functional level and/or days of sickness absence - when provided in combination with other elements to people with subacute/chronic back pain. The present study set out to test the effect of this kind of resassuring information alone.
Between November 2012 and September 2013, we included app. 500 municipal workers perfoming either manual work, administrative work or a combination of the two. Participants worked in 5 different municipal workplaces. These workplaces were characterized by being devided into 'natural working unit', which had no or very little daily contact. All 5 workplaces participated with at least 2 units. Thus 11 units contributed to the data. Baseline assessment took place during right upon recruitment prior to randomization.
We cluster-randomized the 11 units into an intervention and a control group using a simple stepwise randomization-metod.
The intervention group received two 45-minute lectures at the workplace with an interval of 2 weeks. The lectures were coherent allthough different. They consisted of information on the scientific knowledge on the etiology of LBP, basic anatomy, common myths about LBP, a theory of non-specific LBP being caused by muscular functional disturbances (Indahl 1999), pain physiology, and scientific knowledge on seemingly appropriate coping strategies to prevent a prolonged course. Emphasis was made to reduce pain-related fear of movement and catastrophizing thoughts and beliefs. Instead, activity during pain episodes was promoted as well as a natural use of the back despite pain. A non-directive approach was used (non-imperativ wording and absence of giving advice). The purpose was to provide information but let the participant make their own conclusions on how and if to use the information in present/future coping with pain.
In addition to the lecture, the intervention group participants were provided with a leaflet showing various relevenat stretching exercises (back and related muscles) and they were offered the option to make a call to the primary investigator in case any questions would arise subsequently.
The control group was untreated by us. Both groups had access to all 'usual' help (workplace, general practitioner etc).
Upon completion of the lectures, twelve monthly assessments were conducted using Text Messaging (SMS). During each assessment, participants answered questions on no. of LBP days, no. of LBP-related cutdown days, no. of LBP-related sick days, no. of LBP-related healthcare visits, overall workability, bothersomeness last week, restricted activity last week, and use of pain medicine or degree of sadness/depression.
In addition, a separate assessment was performed at app. 5.5 monts to obtain responses on back beliefs.
The data collection was completed in 2014. Analysis are nearly finished. The sicentific paper on the study is anticipated to take place in the beginning of 2016.
- Conditions
- Non-specific Low Back Pain
- Being tested
- Talks about what science says about LBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talks about what science says about LBPBehavioural
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Talks on scientific status on back pain with the purpose of reducing LBP-related insecurity/fear, reducing the focus on the pain and providing participants with alternative explanation to their LBP. They were also provided with a folder (general stretching exercises) and had telephone access to health professional if they had questions about LBP during the follow-up year. Receives: Behavioral: Talks about what science says about LBP |
| Control group | No intervention | No intervention will be provided by the study team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Level
item 2 \& 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
Measured: 12 months
Sickness absence (analysed as work participation)
item 5 in the COMI (Deyo et al. 1998)
Measured: 12 months
Secondary outcomes (2)
No. of monthly healthcare visits
Number of monthly visits to any kind of healthcare provider
Measured: 12 months
Back beliefs
item 10 \& 12-14 from the Back Beliefs Questionnaire
Measured: 5.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, University of Huddersfield, University of Bergen
- Responsible party
- Principal investigator, Pernille Frederiksen, Glostrup University Hospital, Copenhagen
- Investigators
- Tom Bendix, Professor, Study chair, Copenhagen Center for Back Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918228
- Sponsor's protocol ID
- VRRPhDPF
- Other IDs
- PF2013
- Acronym
- VRRPF
- Status last verified
- Aug 2017
- First submitted
- 25 Apr 2013
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.
- ClinicalTrials.gov ID
- NCT01918228
- Acronym / sponsor ID
- VRRPF / VRRPhDPF
- Conditions
- Non-specific Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Collaborators
- National Research Centre for the Working Environment, Denmark, University of Huddersfield, University of Bergen
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Aug 2013 (estimated)
- 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.
RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour.
Detailed description
Previous studies have strongly implied that information is a valuable means for people suffering from LBP in terms of coping appropriately. Most studies have tested the effect of information as part of a multimodal intervention.
Four Nordic studies testing the effect of 'reassuring information' based on the 'Functional Disturbance'-model (proposed by Indahl et al. 1999 - also called the 'non-injury'-model) have all been effective at positively altering the functional level and/or days of sickness absence - when provided in combination with other elements to people with subacute/chronic back pain. The present study set out to test the effect of this kind of resassuring information alone.
Between November 2012 and September 2013, we included app. 500 municipal workers perfoming either manual work, administrative work or a combination of the two. Participants worked in 5 different municipal workplaces. These workplaces were characterized by being devided into 'natural working unit', which had no or very little daily contact. All 5 workplaces participated with at least 2 units. Thus 11 units contributed to the data. Baseline assessment took place during right upon recruitment prior to randomization.
We cluster-randomized the 11 units into an intervention and a control group using a simple stepwise randomization-metod.
The intervention group received two 45-minute lectures at the workplace with an interval of 2 weeks. The lectures were coherent allthough different. They consisted of information on the scientific knowledge on the etiology of LBP, basic anatomy, common myths about LBP, a theory of non-specific LBP being caused by muscular functional disturbances (Indahl 1999), pain physiology, and scientific knowledge on seemingly appropriate coping strategies to prevent a prolonged course. Emphasis was made to reduce pain-related fear of movement and catastrophizing thoughts and beliefs. Instead, activity during pain episodes was promoted as well as a natural use of the back despite pain. A non-directive approach was used (non-imperativ wording and absence of giving advice). The purpose was to provide information but let the participant make their own conclusions on how and if to use the information in present/future coping with pain.
In addition to the lecture, the intervention group participants were provided with a leaflet showing various relevenat stretching exercises (back and related muscles) and they were offered the option to make a call to the primary investigator in case any questions would arise subsequently.
The control group was untreated by us. Both groups had access to all 'usual' help (workplace, general practitioner etc).
Upon completion of the lectures, twelve monthly assessments were conducted using Text Messaging (SMS). During each assessment, participants answered questions on no. of LBP days, no. of LBP-related cutdown days, no. of LBP-related sick days, no. of LBP-related healthcare visits, overall workability, bothersomeness last week, restricted activity last week, and use of pain medicine or degree of sadness/depression.
In addition, a separate assessment was performed at app. 5.5 monts to obtain responses on back beliefs.
The data collection was completed in 2014. Analysis are nearly finished. The sicentific paper on the study is anticipated to take place in the beginning of 2016.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Talks about what science says about LBPTalks on scientific status on back pain with the purpose of reducing LBP-related insecurity/fear, reducing the focus on the pain and providing participants with alternative explanation to their LBP. They were also provided with a folder (general stretching exercises) and had telephone access to health professional if they had questions about LBP during the follow-up year. |
| Control group | No intervention | –No intervention will be provided by the study team. |
Who may qualify
- Ages
- 18 to 72 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -employed at one of the participating municipal workplaces
Key exclusion criteria (4 listed)
- pregnancy within the first 6 months of the study
- physical or mental disease that has significant impact on the individual in terms of pain (eg. Rheumathoid disease, clinical depression)
- present cancer disease (risk of metastasis)
- planned stop at the workplace within the first 6 months of the study
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 |
|---|---|---|
| Talks about what science says about LBPTwo talks, a folder with general stretching exercises and possibility to contact health professional by telephone | Behavioural | Intervention group |
Primary outcome
Functional Level
Time frame: 12 months
item 2 \& 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
Sickness absence (analysed as work participation)
Time frame: 12 months
item 5 in the COMI (Deyo et al. 1998)
2 secondary outcomes
No. of monthly healthcare visits
Time frame: 12 months
Back beliefs
Time frame: 5.5 months
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 23 Aug 2017.
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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.
Tom Bendix, Professor study chair
Copenhagen Center for Back Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Talks about what science says about LBP in people with Non-specific Low Back Pain, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
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 4 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 23 Aug 2017. 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 Denmark. 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?
Functional Level (time frame: 12 months). 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 23 Aug 2017.