The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
Primary Purpose
Low Back Pain
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Back pain screening test
Sponsored by
About this trial
This is an interventional screening trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- Seeking care for low back pain at any of the included primary Health care.
Exclusion Criteria:
- Red flags
Sites / Locations
- FoUSpenshultRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Back pain screening group
treatment as usual
Arm Description
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.
The Group get treatment as usual, where the care giver base the rehabilitation plan without taking the scorings from the screening tool into consideration.
Outcomes
Primary Outcome Measures
Number of physiotherapy treatments
Number of treatments given by physiotherapist
Number of physiotherapy treatments
Number of treatments given by physiotherapist
Secondary Outcome Measures
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)
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)
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).
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).
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)
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)
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.
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.
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")
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")
Full Information
NCT ID
NCT03368521
First Posted
November 14, 2017
Last Updated
December 20, 2017
Sponsor
FoU Center Spenshult
1. Study Identification
Unique Protocol Identification Number
NCT03368521
Brief Title
The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
Official Title
The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
FoU Center Spenshult
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Back pain screening group
Arm Type
Other
Arm Description
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.
Arm Title
treatment as usual
Arm Type
No Intervention
Arm Description
The Group get treatment as usual, where the care giver base the rehabilitation plan without taking the scorings from the screening tool into consideration.
Intervention Type
Other
Intervention Name(s)
Back pain screening test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of physiotherapy treatments
Description
Number of treatments given by physiotherapist
Time Frame
4 months after inclusion
Title
Number of physiotherapy treatments
Description
Number of treatments given by physiotherapist
Time Frame
12 months after inclusion
Secondary Outcome Measure Information:
Title
back pain questionnaire - The Keele STarT Back Screening Tool
Description
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)
Time Frame
4 months after inclusion
Title
back pain questionnaire - The Keele STarT Back Screening Tool
Description
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)
Time Frame
12 months after inclusion
Title
back pain questionnaire - Pain distribution
Description
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).
Time Frame
4 months after inclusion
Title
back pain questionnaire - Pain distribution
Description
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).
Time Frame
12 months after inclusion
Title
back pain questionnaire - The Roland-Morris Disability Questionnaire
Description
The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability)
Time Frame
4 months after inclusion
Title
back pain questionnaire - The Roland-Morris Disability Questionnaire
Description
The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability)
Time Frame
12 months after inclusion
Title
work ability - Work productivity and activity impairment questionnaire (WPAI)
Description
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.
Time Frame
4 months after inclusion
Title
work ability - Work productivity and activity impairment questionnaire (WPAI)
Description
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.
Time Frame
12 months after inclusion
Title
work ability - The work ability index (WAI)
Description
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")
Time Frame
4 months after inclusion
Title
work ability - The work ability index (WAI)
Description
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")
Time Frame
12 months after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Seeking care for low back pain at any of the included primary Health care.
Exclusion Criteria:
Red flags
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emma Haglund, PhD
Phone
0046 35 220202
Email
emma.haglund@spenshult.se
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Andersson, PhD
Phone
0046-35-220202
Email
maria.andersson@spenshult.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Bergman, PhD
Organizational Affiliation
FoU Center Spenshult
Official's Role
Study Chair
Facility Information:
Facility Name
FoUSpenshult
City
Halmstad
ZIP/Postal Code
30274
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emma Haglund, PhD
Phone
046-35-220202
12. IPD Sharing Statement
Learn more about this trial
The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
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