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

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Levanger Hospital

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT01158339

First received: May 21, 2010

Last updated: January 14, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 21, 2010
Last Updated Date	January 14, 2013
Start Date ^ICMJE	January 2010
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 14, 2013)	Absenteeism from work [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)
Original Primary Outcome Measures ^ICMJE (submitted: July 7, 2010)	Absenteeism from work [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Registrations of absenteeism will be given by the Norwegian Sickleave Register. This has certaainly to be retrospectively(Is allready approved)
Change History	Complete list of historical versions of study NCT01158339 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 14, 2013)	Pain [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: No ] Pain. Pain Brief Inventory Physical functioning. [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Physical functioning: SF-8 health survey 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. ] [ Designated as safety issue: Yes ] Emotional functioning: Beck Depression Inventory Patient ratings of improvement and satisfaction with treatment [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Questionaire Health-related quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Questionaire 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. ] [ Designated as safety issue: Yes ] Other symptoms and adverse events during treatment Patient disposition and characteristics data Sideeffects [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Any types. Drugs are not at all introduced in the study Quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Health-related quality of life
Original Secondary Outcome Measures ^ICMJE (submitted: July 7, 2010)	Pain [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: No ] Pain. Pain Brief Inventory Physical functioning. [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Physical functioning: SF-8 health survey 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. ] [ Designated as safety issue: Yes ] Emotional functioning: Beck Depression Inventory Patient ratings of improvement and satisfaction with treatment [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Questionaire Health-related quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Questionaire 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. ] [ Designated as safety issue: Yes ] Other symtoms and adverse events during treatment Patient disposition and characteristics data Sideeffects [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Any types. Drugs are not at all introduced in the study Quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ] [ Designated as safety issue: Yes ] Health-related quality of life
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain
Official Title ^ICMJE	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
Brief 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 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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Low Back Pain
Intervention ^ICMJE	Behavioral: Arm 2: CBGT-ISE Intervention with active performance of the feared movements during group sessions. Behavioral: Arm 1: CBGT Intervention according to previously mentioned methods.
Study Arm (s)	Active Comparator: Arm 1: CBGT Cognitive Behavioural Group Therapy (CBGT) Intervention: Behavioral: Arm 1: CBGT Experimental: Arm 2: CBGT-ISE Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE). Intervention: Behavioral: Arm 2: CBGT-ISE
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	January 2016
Estimated Primary Completion Date	January 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Age 18 to 60 years. 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. Exclusion Criteria: 100 % disability pension, of any reason. LBP that clearly is secondary to other somatic or psychiatric disorders. Age <18 and >60 years. 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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Norway

Administrative Information
NCT Number ^ICMJE	NCT01158339
Other Study ID Numbers ^ICMJE	REK No 2010/48-2
Has Data Monitoring Committee	Yes
Responsible Party	Norwegian University of Science and Technology
Study Sponsor ^ICMJE	Norwegian University of Science and Technology
Collaborators ^ICMJE	Levanger Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	Norwegian University of Science and Technology
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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