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

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.

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Back pain screening test

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Emma Haglund, PhD; Phone Number: 0046 35 220202; Email: emma.haglund@spenshult.se
• Study Contact Backup: Name: Maria Andersson, PhD; Phone Number: 0046-35-220202; Email: maria.andersson@spenshult.se

Study Locations

• Sweden
  • Halmstad, Sweden, 30274
    • Recruiting
    • FoUSpenshult
    • Contact: Emma Haglund, PhD; Phone Number: 046-35-220202

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Red flags

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Back pain screening group; 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; 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.
No Intervention: treatment as usual; 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?

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

Collaborators and Investigators

• Sponsor: FoU Center Spenshult
• Investigators: Study Chair: Stefan Bergman, PhD, FoU Center Spenshult

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Anticipated): June 1, 2019
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: November 14, 2017
• First Submitted That Met QC Criteria: December 5, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: Low back pain_RCT_2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No