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Assessing a risk tailored intervention to prevent disabling low back pain--protocol of a cluster randomized controlled trial.

Schmidt CO, Chenot JF, Pfingsten M, Fahland RA, Lindena G, Marnitz U, Pfeifer K, Kohlmann T - BMC Musculoskelet Disord (2010)

Bottom Line: Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.Subsequently they receive an educational intervention including information and counselling tailored to the risk group.The primary outcomes will be functional capacity and sick leave.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General Practice, University of Göttingen, Humboldtallee 38, D-37073 Göttingen, Germany.

ABSTRACT

Background: Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.

Methods/design: This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave.

Discussion: This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice.

Trial registration: ISRCTN 68205910.

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Related in: MedlinePlus

Back pain and related variables recorded at baseline and after 6 and 12 months.
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Figure 1: Back pain and related variables recorded at baseline and after 6 and 12 months.

Mentions: The study is a two-armed cluster-randomized controlled study. General practices will be assigned at random to the control or intervention arm of the study and subsequently recruit patients. This cluster randomization approach is frequently used in ambulatory settings because of its high degree of internal validity and for pragmatic reasons[38]. Twenty GPs shall participate in each study region of whom half will be assigned to the control or the intervention group. Each GP should recruit 30 patients. This will lead to a total of 1200 patients with 600 belonging to the intervention, and 600 to the control arm of the study, respectively. Back pain and related variables will be recorded at baseline and after 6 and 12 months as outlined in Figure 1.


Assessing a risk tailored intervention to prevent disabling low back pain--protocol of a cluster randomized controlled trial.

Schmidt CO, Chenot JF, Pfingsten M, Fahland RA, Lindena G, Marnitz U, Pfeifer K, Kohlmann T - BMC Musculoskelet Disord (2010)

Back pain and related variables recorded at baseline and after 6 and 12 months.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2820020&req=5

Figure 1: Back pain and related variables recorded at baseline and after 6 and 12 months.
Mentions: The study is a two-armed cluster-randomized controlled study. General practices will be assigned at random to the control or intervention arm of the study and subsequently recruit patients. This cluster randomization approach is frequently used in ambulatory settings because of its high degree of internal validity and for pragmatic reasons[38]. Twenty GPs shall participate in each study region of whom half will be assigned to the control or the intervention group. Each GP should recruit 30 patients. This will lead to a total of 1200 patients with 600 belonging to the intervention, and 600 to the control arm of the study, respectively. Back pain and related variables will be recorded at baseline and after 6 and 12 months as outlined in Figure 1.

Bottom Line: Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.Subsequently they receive an educational intervention including information and counselling tailored to the risk group.The primary outcomes will be functional capacity and sick leave.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of General Practice, University of Göttingen, Humboldtallee 38, D-37073 Göttingen, Germany.

ABSTRACT

Background: Although most patients with low back pain (LBP) recover within a few weeks a significant proportion has recurrent episodes or will develop chronic low back pain. Several mainly psychosocial risk factors for developing chronic LBP have been identified. However, effects of preventive interventions aiming at behavioural risk factors and unfavourable cognitions have yielded inconsistent results. Risk tailored interventions may provide a cost efficient and effective means to take systematic account of the individual risk factors but evidence is lacking.

Methods/design: This study will be a cluster-randomised controlled trial comparing screening and a subsequent risk tailored intervention for patients with low back pain to prevent chronic low back pain compared to treatment as usual in primary care. A total of 600 patients from 20 practices in each study arm will be recruited in Berlin and Goettingen. The intervention comprises the following elements: Patients will be assigned to one of four risk groups based on a screening questionnaire. Subsequently they receive an educational intervention including information and counselling tailored to the risk group. A telephone/email consulting service for back pain related problems are offered independent of risk group assignment. The primary outcomes will be functional capacity and sick leave.

Discussion: This trial will evaluate the effectiveness of screening for risk factors for chronic low back pain followed by a risk tailored intervention to prevent chronic low back pain. This trial will contribute new evidence regarding the flexible use of individual physical and psychosocial risk factors in general practice.

Trial registration: ISRCTN 68205910.

Show MeSH
Related in: MedlinePlus