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Enhanced Implementation of Low Back Pain Guidelines in General Practice

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: NCT01699256
Recruitment Status : Completed
First Posted : October 3, 2012
Last Update Posted : November 30, 2016
Aalborg University
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
The aim of this study is to evaluate whether an enhanced strategy of implementation of the new guideline will lower the number of patients getting referred to secondary care spine centres compared to a normal implementation strategy.

Condition or disease Intervention/treatment Phase
Low Back Pain Behavioral: Guideline implementation as usual Behavioral: Enhanced guideline implementation strategy Not Applicable

Detailed Description:


There is a need for more knowledge on how to introduce new guidelines effectively in general practice. A new low back pain treatment guideline is implemented in Denmark. This guideline demands that patients with low back pain who have not improved after eight weeks of primary care treatment should be referred to a secondary care spine centre.


This is a cluster randomized trial. One hundred general practices define clusters and are randomly allocated to enhanced or usual implementation of the new guideline. The practices are all situated in the North Denmark Region and count two hundred general practitioners (GPs).

General practices in the control group will receive normal implementation of the new guideline, which include newsletters and briefings. In contrast the intervention group will receive an enhanced implementation strategy, adding visits from a consultant, two different stratification tools and feedback on guideline compliance. The two stratification tools: The STarT back screening tool (STarT) and a "Social and Occupational Screening" tool (SOS). The two screening tools subgroups patients and aids the clinicians in their choice of treatment.


To evaluate how change in behaviour may improve guideline adherence and patient treatment we plan two Ph.d. studies in relation to this study; one focusing on the clinical and an one on the economic aspects of the study. In addition a qualitative study is planned for patients refered to specialists in social medicine.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial
Study Start Date : October 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Enhanced strategy
Enhanced implementation strategy
Behavioral: Enhanced guideline implementation strategy
Enhanced guideline implementation strategy

Active Comparator: Strategy as usual
Normal implementation strategy
Behavioral: Guideline implementation as usual
Newsletters and Invitation to Meetings

Primary Outcome Measures :
  1. Referral of patients to a secondary care back centre [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 4, 8, and 52 weeks ]
  2. Roland Morris 23q disability score [ Time Frame: 4, 8, and 52 weeks ]
  3. Numerical pain rating [ Time Frame: 4, 8, and 52 weeks ]
  4. EQ-5D (Life quality) [ Time Frame: 4, 8, and 52 weeks ]
  5. Sick-leave [ Time Frame: 4, 8, and 52 weeks ]
  6. Employment status [ Time Frame: 4, 8, and 52 weeks ]

Other Outcome Measures:
  1. Guideline compliance [ Time Frame: During study ]
  2. Actual delivered intervention [ Time Frame: During study ]
  3. Association between the STart Bact Tool and the functional disability [ Time Frame: 8 weeks ]
    An ancillary analysis of the predictive ability of the STarT Back Tool

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Provider number in the North Denmark Region (Practice level)
  • ICPC coded: L02, L03, L84, and L86 (Patient level)
  • Age 18-65 years (Patient level)

Exclusion Criteria:

  • No signed written consent form (Practice level)
  • Earlier participation in project testing (Practice level)
  • Already included (Patient level)
  • Patients with "red flags"/signs of serious pathology (Patient level)
  • Pregnancy (Patient level)
  • Insufficient Danish language skills (Patient level)

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): NCT01699256

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Research Unit for General Practice in the North Denmark Region
Aalborg, Denmark, 9220
Sponsors and Collaborators
University of Aarhus
Aalborg University
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Principal Investigator: Allan Riis, Master University of Aarhus
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Aarhus Identifier: NCT01699256    
Other Study ID Numbers: 2008-58-0028
First Posted: October 3, 2012    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: July 2015
Keywords provided by University of Aarhus:
General Practice
Low Back Pain
Health Plan Implementation
Referral and Consultation
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms