The Right Intervention for the Right Patient
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Biopsychosocial intervention
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low back pain, Return to work, Biopsychosocial, Screening, SMS, Non specific low back pain
Eligibility 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
Sites / Locations
- The Back Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
psychosocial intervention
Usual care
Outcomes
Primary Outcome Measures
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire
Secondary Outcome Measures
Pain level
Activity of daily living
Full Information
NCT ID
NCT00459433
First Posted
April 10, 2007
Last Updated
May 28, 2009
Sponsor
The Back Research Center, Denmark
Collaborators
European Commission
1. Study Identification
Unique Protocol Identification Number
NCT00459433
Brief Title
The Right Intervention for the Right Patient
Official Title
The Right Intervention for the Right Patient
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
The Back Research Center, Denmark
Collaborators
European Commission
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low back pain, Return to work, Biopsychosocial, Screening, SMS, Non specific low back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
psychosocial intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Usual care
Intervention Type
Procedure
Intervention Name(s)
Biopsychosocial intervention
Intervention Description
Psychosocial versus usual care
Primary Outcome Measure Information:
Title
Days on sick leave and days with low back pain problems measured every week by SMS questionnaire
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Pain level
Time Frame
12 months
Title
Activity of daily living
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bendt Johansen, MHS
Organizational Affiliation
Affiliated with University of Southern Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Back Research Center
City
Ringe
ZIP/Postal Code
5750
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
15082998
Citation
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.
Results Reference
background
PubMed Identifier
11790467
Citation
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. doi: 10.1016/s0304-3959(01)00374-8.
Results Reference
background
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The Right Intervention for the Right Patient
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