The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain

Study Overview
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Brief Summary
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This study aims to investigate if a low back pain screening tool is helpful for the caregivers to direct the rehabilitation in a more efficient way, at an earlier stage. Primary Health care centers in the municipality of Halmstad, Sweden will be enrolled to participate in the study as either Control or intervention. The primary Health care centers who are enrolled taking part in the intervention, will use the provided screening tool when taking care of patients seeking care for low back pain. Scorings from the screening tool will label the patients as one of Three pre-defined risk levels. The caregiver will then use the provided risk level when deciding how to proceed the rehabilitation. Based on the risk level identified, the patient is directed to one of three levels of treatments - including simple advice; physiotherapy; or multimodal rehabilitation. The screening tool is used as a complement to the examination, allowing the physiotherapist /GP to decide how to proceed with rehabilitation using the back screening tool, together with Clinical examinations. The Control Group consists of patients recruited when seeking care for back pain at a Primary Health Care service who has been randomly selected as Control. The care givers at the Control primary Health care will conduct as usual, not using the back pain screening tool in their Clinical examinations.

Official Title
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The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Back pain screening test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking care for low back pain at any of the included primary Health care. Exclusion Criteria: Red flags

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Back pain screening group<br>Includes the Group of patients where the care giver has used the back pain screening tests studied in order to judge how to proceed with rehabilitation, which level of rehabilitation is appropriate. | Other: Back pain screening test<br>* The care giver use the screening tool in order to score the back patient to three levels of risk. For each level of risk, one suggested type of care is provided; 1) simple advise; 2) physiotherapy; 3) multimodal rehabilitation. highest risk level includes multimodal intervention.<br>|
| No Intervention: treatment as usual<br>The Group get treatment as usual, where the care giver base the rehabilitation plan without taking the scorings from the screening tool into consideration. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of physiotherapy treatments | Number of treatments given by physiotherapist | 4 months after inclusion | 
| Number of physiotherapy treatments | Number of treatments given by physiotherapist | 12 months after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| back pain questionnaire - The Keele STarT Back Screening Tool | The Keele STarT Back Screening Tool, is a prognostic tool helping clinicians identify risk factors for persistent back pain. 9 questions. Total score range from 0 to 9 (best- to worse) | 4 months after inclusion | 
| back pain questionnaire - The Keele STarT Back Screening Tool | The Keele STarT Back Screening Tool, is a prognostic tool helping clinicians identify risk factors for persistent back pain. 9 questions. Total score range from 0 to 9 (best- to worse) | 12 months after inclusion | 
| back pain questionnaire - Pain distribution | Pain distribution (numbers of marked regions and location) will be measured by a pain mannequin divided into 18 body regions.The patients mark each region with pain lasting more than three months during the past 12 months. The total number of regions giving a total score 0-18 (few to several regions, best- to worse). | 4 months after inclusion | 
| back pain questionnaire - Pain distribution | Pain distribution (numbers of marked regions and location) will be measured by a pain mannequin divided into 18 body regions.The patients mark each region with pain lasting more than three months during the past 12 months. The total number of regions giving a total score 0-18 (few to several regions, best- to worse). | 12 months after inclusion | 
| back pain questionnaire - The Roland-Morris Disability Questionnaire | The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability) | 4 months after inclusion | 
| back pain questionnaire - The Roland-Morris Disability Questionnaire | The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability) | 12 months after inclusion | 
| work ability - Work productivity and activity impairment questionnaire (WPAI) | Work productivity and activity impairment questionnaire (WPAI) with 6 questions assessing the impact of the disease on work and other daily activities during the previous 7 days (absenteeism, presenteeism, impaired activities outside work, and overall work impairment). Each component is expressed as percentage of impairment due to the disease (0-100%) where a higher percentage indicates a greater reduction. | 4 months after inclusion | 
| work ability - Work productivity and activity impairment questionnaire (WPAI) | Work productivity and activity impairment questionnaire (WPAI) with 6 questions assessing the impact of the disease on work and other daily activities during the previous 7 days (absenteeism, presenteeism, impaired activities outside work, and overall work impairment). Each component is expressed as percentage of impairment due to the disease (0-100%) where a higher percentage indicates a greater reduction. | 12 months after inclusion | 
| work ability - The work ability index (WAI) | The work ability index (WAI) single-item question concerned the item current work ability compared with the lifetime best, with a possible score of 0 (completely unable to work) to 10 (work ability at its best) | 4 months after inclusion | 
| work ability - The work ability index (WAI) | The work ability index (WAI) single-item question concerned the item current work ability compared with the lifetime best, with a possible score of 0 (completely unable to work) to 10 (work ability at its best) | 12 months after inclusion |