search
Back to results

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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Arm 2: CBGT-ISE
Arm 1: CBGT
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Cognitive behavioural therapy, Group therapy, Exposure in session

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Levanger Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: CBGT

Arm 2: CBGT-ISE

Arm Description

Cognitive Behavioural Group Therapy (CBGT)

Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain
Pain. Pain Brief Inventory
Physical functioning.
Physical functioning: SF-8 health survey Will be done the following weeks: -1., 6., 14., and 52.
Emotional functioning
Emotional functioning: Beck Depression Inventory
Patient ratings of improvement and satisfaction with treatment
Questionaire
Health-related quality of life
Questionaire
Coping/catastrophising
Other symptoms and adverse events during treatment Patient disposition and characteristics data
Side effects
Any types. Drugs are not at all introduced in the study
Quality of life
Health-related quality of life

Full Information

First Posted
May 21, 2010
Last Updated
September 6, 2021
Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF
search

1. Study Identification

Unique Protocol Identification Number
NCT01158339
Brief Title
Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain
Acronym
Ryggbra
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Helse Nord-Trøndelag HF

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Cognitive behavioural therapy, Group therapy, Exposure in session

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: CBGT
Arm Type
Active Comparator
Arm Description
Cognitive Behavioural Group Therapy (CBGT)
Arm Title
Arm 2: CBGT-ISE
Arm Type
Experimental
Arm Description
Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).
Intervention Type
Behavioral
Intervention Name(s)
Arm 2: CBGT-ISE
Intervention Description
Intervention with active performance of the feared movements during group sessions.
Intervention Type
Behavioral
Intervention Name(s)
Arm 1: CBGT
Intervention Description
Intervention according to previously mentioned methods.
Primary Outcome Measure Information:
Title
Absenteeism from work
Description
Registrations of absenteeism will be given by the Norwegian Sick leave Register. This has certainly to be retrospectively (Is already approved)
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Pain
Description
Pain. Pain Brief Inventory
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Physical functioning.
Description
Physical functioning: SF-8 health survey Will be done the following weeks: -1., 6., 14., and 52.
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Emotional functioning
Description
Emotional functioning: Beck Depression Inventory
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Patient ratings of improvement and satisfaction with treatment
Description
Questionaire
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Health-related quality of life
Description
Questionaire
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Coping/catastrophising
Description
Other symptoms and adverse events during treatment Patient disposition and characteristics data
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.
Title
Side effects
Description
Any types. Drugs are not at all introduced in the study
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.
Title
Quality of life
Description
Health-related quality of life
Time Frame
Will be done the following weeks: -1., 6., 14., and 52.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tore Charles Stiles, prof
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Director
Facility Information:
Facility Name
Levanger Hospital
City
Levanger
ZIP/Postal Code
7600
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
32964624
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs