The Right Intervention for the Right Patient
1 other identifier
interventional
300
1 country
1
Brief Summary
Complicated and expensive interventions are used to treat unspecific low back pain and the intervention is not always targeted the patients specific problems.It is therefore not surprising that a large fraction of unspecific low back pain patients do not respond very well to the usual biopsychosocial intervention. We would therefore like to identify the patients specific problems regarding the patients biomedical, psychological, and social needs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable low-back-pain
Started Oct 2006
Longer than P75 for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 10, 2007
CompletedFirst Posted
Study publicly available on registry
April 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedMay 29, 2009
May 1, 2009
2.6 years
April 10, 2007
May 28, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire
12 months
Secondary Outcomes (2)
Pain level
12 months
Activity of daily living
12 months
Study Arms (2)
1
EXPERIMENTALpsychosocial intervention
2
ACTIVE COMPARATORUsual care
Interventions
Eligibility Criteria
You may qualify if:
- Unspecific low back pain
- Level of low back pain must be at least equal to leg pain
- Patients must have been sick listed during the past 12 months
- Age \> 17 years and \< than 60
You may not qualify if:
- Modic changes as seen on MRI
- Direct or progressive paresis or Cauda equina syndrome
- Known MB Bechterew or Sacroiliitis
- Suspicion of other serious malignancy
- Alcohol or medicine abuse
- A screening result of more than 30 in the Beck Depression Inventory
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Back Research Center, Denmarklead
- European Commissioncollaborator
Study Sites (1)
The Back Research Center
Ringe, 5750, Denmark
Related Publications (2)
Johansen B, Mainz J, Sabroe S, Manniche C, Leboeuf-Yde C. Quality improvement in an outpatient department for subacute low back pain patients: prospective surveillance by outcome and performance measures in a health technology assessment perspective. Spine (Phila Pa 1976). 2004 Apr 15;29(8):925-31. doi: 10.1097/00007632-200404150-00021.
PMID: 15082998BACKGROUNDHaldorsen EM, Grasdal AL, Skouen JS, Risa AE, Kronholm K, Ursin H. Is there a right treatment for a particular patient group? Comparison of ordinary treatment, light multidisciplinary treatment, and extensive multidisciplinary treatment for long-term sick-listed employees with musculoskeletal pain. Pain. 2002 Jan;95(1-2):49-63. doi: 10.1016/s0304-3959(01)00374-8.
PMID: 11790467BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bendt Johansen, MHS
Affiliated with University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 10, 2007
First Posted
April 12, 2007
Study Start
October 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
May 29, 2009
Record last verified: 2009-05