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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158339
Recruitment Status : Active, not recruiting
First Posted : July 8, 2010
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Levanger Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment
Low Back Pain Behavioral: Arm 2: CBGT-ISE Behavioral: Arm 1: CBGT

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2010
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1: CBGT
Cognitive Behavioural Group Therapy (CBGT)
Behavioral: Arm 1: CBGT
Intervention according to previously mentioned methods.
Experimental: Arm 2: CBGT-ISE
Cognitive Behavioural Group Therapy, with in-Session Exposure (CBGT-ISE).
Behavioral: Arm 2: CBGT-ISE
Intervention with active performance of the feared movements during group sessions.



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Pain [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Pain. Pain Brief Inventory

  2. Physical functioning. [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]

    Physical functioning: SF-8 health survey

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


  3. Emotional functioning [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Emotional functioning: Beck Depression Inventory

  4. Patient ratings of improvement and satisfaction with treatment [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Questionaire

  5. Health-related quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Questionaire

  6. 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. ]
    Other symptoms and adverse events during treatment Patient disposition and characteristics data

  7. Side effects [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Any types. Drugs are not at all introduced in the study

  8. Quality of life [ Time Frame: Will be done the following weeks: -1., 6., 14., and 52. ]
    Health-related quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158339


Locations
Norway
Levanger Hospital
Levanger, Norway, 7600
Sponsors and Collaborators
Norwegian University of Science and Technology
Levanger Hospital
Investigators
Study Director: Tore Charles Stiles, prof Norwegian University of Science and Technology

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01158339     History of Changes
Other Study ID Numbers: REK No 2010/48-2
First Posted: July 8, 2010    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Low back pain
Cognitive behavioural therapy
Group therapy
Exposure in session

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms