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.

Conditions: Low Back Pain
Being tested: Back pain screening test
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Back pain screening testOther
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.

Study groups in NCT03368521
Study group	Role	What they receive
Back pain screening group	Other	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. Receives: Other: Back pain screening test
treatment as usual	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

Number of physiotherapy treatments
Number of treatments given by physiotherapist
Measured: 4 months after inclusion
Number of physiotherapy treatments
Number of treatments given by physiotherapist
Measured: 12 months after inclusion

Secondary outcomes (10)

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)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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")
Measured: 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")
Measured: 12 months after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 2017Jun 2019

First posted11 Dec 2017
Study start1 Nov 2017
Primary completionJun 2019 (estimated)
Study completionJun 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03368521
Sponsor's protocol ID: Low back pain_RCT_2017
Status last verified: Dec 2017
First submitted: 14 Nov 2017
Last updated: 22 Dec 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Emma Haglund, PhD

0046 35 220202

emma.haglund@spenshult.se

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
ClinicalTrials.gov ID: NCT03368521
Acronym / sponsor ID: Low back pain_RCT_2017
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 150 participants (estimated)
Lead sponsor: FoU Center SpenshultUniversity, hospital or other
Study start: 1 Nov 2017 (actual)
Primary completion: Jun 2019 (estimated)
Study completion: Jun 2019 (estimated)
First posted: 11 Dec 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Back pain screening group	Other	Other: Back pain screening testIncludes 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.
treatment as usual	No intervention	–The Group get treatment as usual, where the care giver base the rehabilitation plan without taking the scorings from the screening tool into consideration.

Who may qualify

Ages: 18 to 67 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

Red flags

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Back pain screening testThe 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.	Other	Back pain screening group

Primary outcome

Number of physiotherapy treatments
Time frame: 4 months after inclusion
Number of treatments given by physiotherapist
Number of physiotherapy treatments
Time frame: 12 months after inclusion
Number of treatments given by physiotherapist

10 secondary outcomes

back pain questionnaire - The Keele STarT Back Screening Tool
Time frame: 4 months after inclusion
back pain questionnaire - The Keele STarT Back Screening Tool
Time frame: 12 months after inclusion
back pain questionnaire - Pain distribution
Time frame: 4 months after inclusion
back pain questionnaire - Pain distribution
Time frame: 12 months after inclusion
back pain questionnaire - The Roland-Morris Disability Questionnaire
Time frame: 4 months after inclusion
back pain questionnaire - The Roland-Morris Disability Questionnaire
Time frame: 12 months after inclusion
work ability - Work productivity and activity impairment questionnaire (WPAI)
Time frame: 4 months after inclusion
work ability - Work productivity and activity impairment questionnaire (WPAI)
Time frame: 12 months after inclusion
work ability - The work ability index (WAI)
Time frame: 4 months after inclusion
work ability - The work ability index (WAI)
Time frame: 12 months after inclusion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emma Haglund, PhD contact

0046 35 220202

emma.haglund@spenshult.se

Maria Andersson, PhD contact

0046-35-220202

maria.andersson@spenshult.se

Stefan Bergman, PhD study chair

FoU Center Spenshult

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Back pain screening test in people with Low Back Pain, run by FoU Center Spenshult at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Emma Haglund, PhD (0046 35 220202, emma.haglund@spenshult.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of physiotherapy treatments (time frame: 4 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03368521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.