The Right Intervention for the Right Patient - Full Text View

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:

MedlinePlus related topics: Back Pain

U.S. FDA Resources

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

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:

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. 2004 Apr 15;29(8):925-31.

Haldorsen 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.

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 May 22, 2013