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The Right Intervention for the Right Patient

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00459433
First Posted: April 12, 2007
Last Update Posted: May 29, 2009
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.
Collaborator:
European Commission
Information provided by:
The Back Research Center, Denmark
April 10, 2007
April 12, 2007
May 29, 2009
October 2006
May 2009   (Final data collection date for primary outcome measure)
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire [ Time Frame: 12 months ]
Days on sick leave
Complete list of historical versions of study NCT00459433 on ClinicalTrials.gov Archive Site
  • Pain level [ Time Frame: 12 months ]
  • Activity of daily living [ Time Frame: 12 months ]
  • Pain level
  • Activity of daily living
Not Provided
Not Provided
 
The Right Intervention for the Right Patient
The Right Intervention for the Right Patient

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.

Two quality assurance investigations are performed in the The Back Research Center Clinic, where one is published in The Spine. The systematics of Health Technology Assessment was used to throw light on important indicators in relation to Health Technology aspects, patient aspects, organisational aspects and economical aspects. At 12 months follow up in 1999, approximately one third of the patients stated that their low back pain was unchanged or worse. In 2004 in a new investigation this fraction was larger. Therefore it seems relevant to be able to identify the patients early in their course in the back ambulatory.

A Norwegian project has shown that when one divides the patients into 3 levels of severity, then the interdisciplinary biopsychosocial intervention had best effect in the intermediary and severe groups. Conversely the mono disciplinary intervention had best effect on the least severe patient group.

Therefore we would like to combine elements from the typical clinical investigation with a screening for psychosocial factors in order to sort patients according to their individual needs.

Even though the bio-psycho-social elements are a coherent continuum one can arbitrarily combine them in 4 groups of increasing complexity.

  • mainly biological
  • both biological and psychological
  • both biological and social
  • both biological, psychological and social It is probably not good enough to give more or less the same type of somatic treatment to all unspecific low back pain patients. It is important to take into account all three elements, the severity of the elements, and the combination of elements. To be able to do this it is important to use a combination of screening instruments that can isolate and quantify the manifestations of the three elements in the patients.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Low Back Pain
Procedure: Biopsychosocial intervention
Psychosocial versus usual care
  • Experimental: 1
    psychosocial intervention
    Intervention: Procedure: Biopsychosocial intervention
  • Active Comparator: 2
    Usual care
    Intervention: Procedure: Biopsychosocial intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2009
May 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT00459433
258
No
Not Provided
Not Provided
Bendt Johansen, MHS, The Back Research Center, Denmark
The Back Research Center, Denmark
European Commission
Principal Investigator: Bendt Johansen, MHS Affiliated with University of Southern Denmark
The Back Research Center, Denmark
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP