The Right Intervention for the Right Patient

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. Identifier: NCT00459433
Recruitment Status : Completed
First Posted : April 12, 2007
Last Update Posted : May 29, 2009
European Commission
Information provided by:
The Back Research Center, Denmark

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Biopsychosocial intervention Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Right Intervention for the Right Patient
Study Start Date : October 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: 1
psychosocial intervention
Procedure: Biopsychosocial intervention
Psychosocial versus usual care

Active Comparator: 2
Usual care
Procedure: Biopsychosocial intervention
Psychosocial versus usual care

Primary Outcome Measures :
  1. Days on sick leave and days with low back pain problems measured every week by SMS questionnaire [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Pain level [ Time Frame: 12 months ]
  2. Activity of daily living [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00459433

The Back Research Center
Ringe, Denmark, 5750
Sponsors and Collaborators
The Back Research Center, Denmark
European Commission
Principal Investigator: Bendt Johansen, MHS Affiliated with University of Southern Denmark

Responsible Party: Bendt Johansen, MHS, The Back Research Center, Denmark Identifier: NCT00459433     History of Changes
Other Study ID Numbers: 258
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: May 29, 2009
Last Verified: May 2009

Keywords provided by The Back Research Center, Denmark:
Low back pain
Return to work
Non specific low back pain

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