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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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 group | Role | What they receive |
|---|---|---|
| Arm 1: CBGT | Active comparator | Cognitive Behavioural Group Therapy (CBGT) Receives: Behavioral: Arm 1: CBGT |
| Arm 2: CBGT-ISE | Experimental | Cognitive 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.
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)
Pain
Pain. Pain Brief Inventory
Measured: Will be done the following weeks: -1., 6., 14., and 52.
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.
Emotional functioning
Emotional functioning: Beck Depression Inventory
Measured: Will be done the following weeks: -1., 6., 14., and 52.
Patient ratings of improvement and satisfaction with treatment
Questionaire
Measured: Will be done the following weeks: -1., 6., 14., and 52.
Health-related quality of life
Questionaire
Measured: Will be done the following weeks: -1., 6., 14., and 52.
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.
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.
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.
- First posted8 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Tore Charles Stiles, prof, Study director, Norwegian University of Science and Technology
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01158339
- Acronym / sponsor ID
- Ryggbra / REK No 2010/48-2
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Cognitive behavioural therapy, Group therapy, Exposure in session
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Helse Nord-Trøndelag HF
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 8 Jul 2010 (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.
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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: CBGT | Active comparator | Behavioral: Arm 1: CBGTCognitive Behavioural Group Therapy (CBGT) |
| Arm 2: CBGT-ISE | Experimental | Behavioral: Arm 2: CBGT-ISECognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Arm 2: CBGT-ISEIntervention with active performance of the feared movements during group sessions. | Behavioural | Arm 2: CBGT-ISE |
| Arm 1: CBGTIntervention according to previously mentioned methods. | Behavioural | Arm 1: CBGT |
Primary outcome
Absenteeism from work
Time frame: Week 52
Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)
8 secondary outcomes
Pain
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Physical functioning.
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Emotional functioning
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Patient ratings of improvement and satisfaction with treatment
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Health-related quality of life
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Coping/catastrophising
Time frame: One week before intervention starts, then week 2 during the intervention, week 6 after finished intervention, week 14 after the booster and week 52.
Side effects
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
Quality of life
Time frame: Will be done the following weeks: -1., 6., 14., and 52.
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 14 Sep 2021.
- Results publication: PubMed 32964624Ryum 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.
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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.
Tore Charles Stiles, prof study director
Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
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.