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Low Back PainRyggbraNCT01158339

Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain

A study testing Arm 2: CBGT-ISE and Arm 1: CBGT in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

Completed

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

Official record
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Trial summary

Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this study is to improve the care of LBP. Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during group sessions focusing on fear and avoidance behaviour will be more effective than physical therapy… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Low Back Pain
What is being tested?
Arm 2: CBGT-ISE and Arm 1: CBGT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteNorway
Study dates
Jan 2010to Dec 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Low Back Pain (LBP) lasting from 3 months to 10 years.
  • Pain of such a severity that life of quality is reduced.
  • The patient's main problem must be LBP, localized from L1 to S1.
  • The pain must not be caused by nerve root affection (e.g. herniated disc)
  • The patient has to be able to understand instructions given in Norwegian and to take part in a group activity.
  • The patient must be partly or fully on sick leave from work.
  • The patient must have a regular work to return to.

Who cannot join

  • 100 % disability pension, of any reason.
  • LBP that clearly is secondary to other somatic or psychiatric disorders.
  • Alcohol and drug abuse.
  • LBP caused by ankylosing spondylitis and other spondylarthropathies.
  • Patients with "red flags" such as bladder- and anal paresis, impotence or progressing paresis.
  • Ongoing insurance affairs for all types of sickness, injuries and accidents both against insurance companies and NAV (The Norwegian Labour and Welfare Administration)
  • Indication for back surgery or performed back surgery last 12 months
  • On medication known to cause depression or other psychiatric symptoms

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Levanger Hospital

    Levanger, 7600

Other trials in Norway

About this study

Official title: Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain A Randomized Controlled Study of Two Methods Comparing the Role of Exposure in Session

Unspecific low back pain (LBP) is a major world wide health problem. The purpose of this study is to improve the care of LBP.

Our hypothesis is that Cognitive Behavioural Therapy (CBT) with physical intervention during group sessions focusing on fear and avoidance behaviour will be more effective than physical therapy alone.

Read more

The study has two arms. Both will receive education related to LBP and appropriate advice regarding how to react and behave towards their LBP.

The main focus in the intervention group will be:

  • Identifying their fear of movements and perform the frightened movements during the group sessions.
  • Reassuring that gradually normalizing daily activities will not be harmful but rather reduce their pain.
Read the detailed description

Cognitive-behavioural treatment is the treatment of choice in the treatment of most patients with chronic LBP. Several randomized controlled trials and recent meta-analysis have demonstrated the potent effects of CBT.

The fear and avoidance model developed by Vlaeyen and Linton has been recommended to be applied in the treatment of patients with chronic low back pain. No randomized controlled study has been published comparing the use of a fear and avoidance treatment with a comparison treatment. Such a study is highly warranted to examine if the model actually has a superior effect compared to other CBT-based treatments. In addition, it is of vital importance to examine whether all patients profit better from such a treatment or whether it only will demonstrate superior effect in a subgroup of patients with chronic low back pain.

PROBLEMS OF INTEREST:

Main aims are to improve the treatment of patients with chronic LBP by:

  • 1) Testing the effect of a treatment assumed by the international scientific community to be the treatment of choice;
  • 2) To develop a diagnostic screening procedure that at an initial examination can differentiate patients that need special treatment attention in the form of exposure towards feared movements from those who can benefit sufficiently from just receiving appropriate advice.
  • 3) To identify the mechanism of change in the treatment of LBP.

METHODS:

Subjects will be recruited from general practitioners in the county of Nord-Trøndelag and from our department.

The study is clinical prospective and randomized. Each session will be videotaped. Two independent raters will rate three random sessions from both the intervention and non-intervention groups. Treatment differentiability will be measured by assessing the amount of time (minutes) spent exposing the patients to various movements in the session (ISE). According to the manuals, amount of ISE in CBGT (cognitive Behavioural Group Therapy) should be zero and between ten to twenty minutes in the CBGT-ISE (cognitive Behavioural Group Therapy- In Session Exposure) condition.

In addition, in both groups the therapists conducting the treatments are instructed to measure amount of time devoted to ISE in each session.

The therapist will rate every session. Three out of six sessions will also be timed and rated by two independent raters. The consistency of the time measured by the therapist and the independent raters will be compared in order to assure correctness of reported time spent in session. The raters will also asses the quality of the sessions. If the ratings are consistent across therapists and independent raters, a total ISE score for each treatment group will be computed.

THE TWO ARMS:

Arm 1: CBGT Patients will be given a manualised group treatment based on a fear and avoidance model. A main focus will be identifying fear of movements. The patients will in a spoken manner be reassured that they gradually can begin to perform normal daily activities and perform movements in a normal manner without using various forms of safety behaviours. Dysfunctional thinking patterns will be identified and challenged. Ten to twenty minutes of each session will be devoted to reassuring patients that various forms of feared movements can be performed in a graded fashion based on a feared hierarchy.

Arm 2: CBGT-ISE Patients will be given a manualised group treatment based on a fear and avoidance model. A main focus will be identifying fear of movements. The patients will in a spoken manner be reassured that they gradually can begin to perform normal daily activities and perform movements in a normal manner without using various forms of safety behaviours. Dysfunctional thinking patterns will be identified and challenged.

Ten to twenty minutes of each session will be devoted to actually exposing the patients to various feared movements and performing these in a graded fashion based on a fear hierarchy.

Conditions
Low Back Pain
Being tested
Arm 2: CBGT-ISE, Arm 1: CBGT
Keywords
Low back pain, Cognitive behavioural therapy, Group therapy, Exposure in session
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Arm 2: CBGT-ISEBehavioural

    Intervention with active performance of the feared movements during group sessions.

  • Arm 1: CBGTBehavioural

    Intervention according to previously mentioned methods.

Study groups in NCT01158339
Study groupRoleWhat they receive
Arm 1: CBGTActive comparatorCognitive Behavioural Group Therapy (CBGT)
Receives: Behavioral: Arm 1: CBGT
Arm 2: CBGT-ISEExperimentalCognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).
Receives: Behavioral: Arm 2: CBGT-ISE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Absenteeism from work

    Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)

    Measured: Week 52

Secondary outcomes (8)
  1. Pain

    Pain. Pain Brief Inventory

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  2. Physical functioning.

    Physical functioning: SF-8 health survey

    Will be done the following weeks: -1., 6., 14., and 52.

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  3. Emotional functioning

    Emotional functioning: Beck Depression Inventory

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  4. Patient ratings of improvement and satisfaction with treatment

    Questionaire

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  5. Health-related quality of life

    Questionaire

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  6. Coping/catastrophising

    Other symptoms and adverse events during treatment Patient disposition and characteristics data

    Measured: One week before intervention starts, then week 2 during the intervention, week 6 after finished intervention, week 14 after the booster and week 52.

  7. Side effects

    Any types. Drugs are not at all introduced in the study

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

  8. Quality of life

    Health-related quality of life

    Measured: Will be done the following weeks: -1., 6., 14., and 52.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2020
  4. Study completionDec 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01158339
Sponsor's protocol ID
REK No 2010/48-2
Acronym
Ryggbra
Status last verified
Sep 2021
First submitted
21 May 2010
Last updated
14 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ryum T, Hartmann H, Borchgrevink P, de Ridder K, Stiles TC. The effect of in-session exposure in Fear-Avoidance treatment of chronic low back pain: A randomized controlled trial. Eur J Pain. 2021 Jan;25(1):171-188. doi: 10.1002/ejp.1659. Epub 2020 Oct 6.

    PubMed 32964624

Questions about this trial

What is this clinical trial studying?

A study testing Arm 2: CBGT-ISE and Arm 1: CBGT in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.

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 7 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 14 Sep 2021. 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 Norway. 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?

Absenteeism from work (time frame: Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01158339, which also lists 1 linked publication.

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 14 Sep 2021; AzTrials last refreshed its copy on 8 Nov 2026.

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