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Enhanced Implementation of Low Back Pain Guidelines in General Practice

Enhanced Implementation of Low Back Pain Guidelines in General Practice: A Cluster Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01699256
Enrollment
1101
Registered
2012-10-03
Start date
2012-10-31
Completion date
2016-05-31
Last updated
2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

General Practice, Low Back Pain, Guideline, Health Plan Implementation, Referral and Consultation

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.

Detailed description

Introduction: 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. Methods: 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. Discussion: 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.

Interventions

BEHAVIORALGuideline implementation as usual

Newsletters and Invitation to Meetings

BEHAVIORALEnhanced guideline implementation strategy

Enhanced guideline implementation strategy

Sponsors

Aalborg University
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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)

Design outcomes

Primary

MeasureTime frame
Referral of patients to a secondary care back centre12 weeks

Secondary

MeasureTime frame
Numerical pain rating4, 8, and 52 weeks
EQ-5D (Life quality)4, 8, and 52 weeks
Sick-leave4, 8, and 52 weeks
Employment status4, 8, and 52 weeks
Cost-effectiveness4, 8, and 52 weeks
Roland Morris 23q disability score4, 8, and 52 weeks

Other

MeasureTime frameDescription
Association between the STart Bact Tool and the functional disability8 weeksAn ancillary analysis of the predictive ability of the STarT Back Tool
Guideline complianceDuring study
Actual delivered interventionDuring study

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026