AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
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.

Denmark1 site
  • Copenhagen Center for Back Research

    Glostrup Municipality, 2600

Other trials in Denmark

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.

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 groups in NCT01918228
Study groupRoleWhat they receive
Intervention groupExperimentalTalks 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 groupNo interventionNo 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.

  1. Functional Level

    item 2 \& 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable

    Measured: 12 months

  2. Sickness absence (analysed as work participation)

    item 5 in the COMI (Deyo et al. 1998)

    Measured: 12 months

Secondary outcomes (2)
  1. No. of monthly healthcare visits

    Number of monthly visits to any kind of healthcare provider

    Measured: 12 months

  2. 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.

  1. First posted7 Aug 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionSep 2014
  4. Study completionApr 2016

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in