Dare to Move: Treatment of Movement Phobia in Patient With Low Back Pain (Ryggbra)
This study is ongoing, but not recruiting participants.
Sponsor:
Norwegian University of Science and Technology
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
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Purpose
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 | Intervention |
|---|---|
|
Low Back Pain |
Behavioral: Arm 2: CBGT-ISE Behavioral: Arm 1: CBGT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 |
Resource links provided by NLM:
Further study details as provided by Norwegian University of Science and Technology:
Primary Outcome Measures:
- 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)
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 120 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | January 2016 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Norwegian University of Science and Technology |
| ClinicalTrials.gov Identifier: | NCT01158339 History of Changes |
| Other Study ID Numbers: | REK No 2010/48-2 |
| Study First Received: | May 21, 2010 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
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 |
ClinicalTrials.gov processed this record on May 21, 2013