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

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ClinicalTrials.gov Identifier: NCT03368521
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
FoU Center Spenshult

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Back pain screening test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: The Benefit of Structured Triage of Patients in the Primary Health Care Seeking Care for Low Back Pain
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Number of physiotherapy treatments [ Time Frame: 4 months after inclusion ]
    Number of treatments given by physiotherapist

  2. Number of physiotherapy treatments [ Time Frame: 12 months after inclusion ]
    Number of treatments given by physiotherapist


Secondary Outcome Measures :
  1. back pain questionnaire - The Keele STarT Back Screening Tool [ Time Frame: 4 months after inclusion ]
    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)

  2. back pain questionnaire - The Keele STarT Back Screening Tool [ Time Frame: 12 months after inclusion ]
    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)

  3. back pain questionnaire - Pain distribution [ Time Frame: 4 months after inclusion ]
    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. back pain questionnaire - Pain distribution [ Time Frame: 12 months after inclusion ]
    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).

  5. back pain questionnaire - The Roland-Morris Disability Questionnaire [ Time Frame: 4 months after inclusion ]
    The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability)

  6. back pain questionnaire - The Roland-Morris Disability Questionnaire [ Time Frame: 12 months after inclusion ]
    The Roland-Morris Disability Questionnaire assess self-rated physical disability Total score range from 0-24 (best to worse disability)

  7. work ability - Work productivity and activity impairment questionnaire (WPAI) [ Time Frame: 4 months after inclusion ]
    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.

  8. work ability - Work productivity and activity impairment questionnaire (WPAI) [ Time Frame: 12 months after inclusion ]
    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.

  9. work ability - The work ability index (WAI) [ Time Frame: 4 months after inclusion ]
    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")

  10. work ability - The work ability index (WAI) [ Time Frame: 12 months after inclusion ]
    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")



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Red flags

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368521


Contacts
Contact: Emma Haglund, PhD 0046 35 220202 emma.haglund@spenshult.se
Contact: Maria Andersson, PhD 0046-35-220202 maria.andersson@spenshult.se

Locations
Sweden
FoUSpenshult Recruiting
Halmstad, Sweden, 30274
Contact: Emma Haglund, PhD    046-35-220202      
Sponsors and Collaborators
FoU Center Spenshult
Investigators
Study Chair: Stefan Bergman, PhD FoU Center Spenshult

Responsible Party: FoU Center Spenshult
ClinicalTrials.gov Identifier: NCT03368521     History of Changes
Other Study ID Numbers: Low back pain_RCT_2017
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms