The Right Intervention for the Right Patient

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by:
The Back Research Center, Denmark
ClinicalTrials.gov Identifier:
NCT00459433
First received: April 10, 2007
Last updated: May 28, 2009
Last verified: May 2009
  Purpose

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 Intervention
Low Back Pain
Procedure: Biopsychosocial intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Right Intervention for the Right Patient

Resource links provided by NLM:


Further study details as provided by The Back Research Center, Denmark:

Primary Outcome Measures:
  • Days on sick leave and days with low back pain problems measured every week by SMS questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain level [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Activity of daily living [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: October 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
psychosocial intervention
Procedure: Biopsychosocial intervention
Psychosocial versus usual care
Active Comparator: 2
Usual care
Procedure: Biopsychosocial intervention
Psychosocial versus usual care

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.
  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459433

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

Publications:
Responsible Party: Bendt Johansen, MHS, The Back Research Center, Denmark
ClinicalTrials.gov Identifier: NCT00459433     History of Changes
Other Study ID Numbers: 258
Study First Received: April 10, 2007
Last Updated: May 28, 2009
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

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

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

ClinicalTrials.gov processed this record on July 29, 2014