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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03368521
• Other study ID #: Low back pain_RCT_2017
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2017
• Last updated: December 20, 2017
• Start date: November 1, 2017
• Est. completion date: June 2019

Study information

• Verified date: December 2017
• Source: FoU Center Spenshult
• Contact: Emma Haglund, PhD
• Phone: 0046 35 220202
• Email: emma.haglund[@]spenshult.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

Inclusion Criteria:

• Seeking care for low back pain at any of the included primary Health care.

Exclusion Criteria:

• Red flags

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Back pain screening test
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.

Locations

Country	Name	City	State
Sweden	FoUSpenshult	Halmstad

Sponsors (1)

Lead Sponsor	Collaborator
FoU Center Spenshult

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of physiotherapy treatments	Number of treatments given by physiotherapist	4 months after inclusion
Primary	Number of physiotherapy treatments	Number of treatments given by physiotherapist	12 months after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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