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

NCT03368521 | Unknown

• 1 other identifier: Low back pain_RCT_2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• back pain questionnaire - The Keele STarT Back Screening Tool

  4 months after inclusion

• back pain questionnaire - The Keele STarT Back Screening Tool

  12 months after inclusion

• back pain questionnaire - Pain distribution

  4 months after inclusion

• back pain questionnaire - Pain distribution

  12 months after inclusion

• back pain questionnaire - The Roland-Morris Disability Questionnaire

  4 months after inclusion

Study Arms (2)

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.

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.

Interventions

Back pain screening test OTHER

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.

Back pain screening group

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Red flags

Sponsors & Collaborators

• FoU Center Spenshult: lead

Study Sites (1)

FoUSpenshult

Halmstad, 30274, Sweden

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Stefan Bergman, PhD

  FoU Center Spenshult

  STUDY CHAIR

Central Study Contacts

Emma Haglund, PhD

CONTACT

0046 35 220202; emma.haglund@spenshult.se

Maria Andersson, PhD

CONTACT

0046-35-220202; maria.andersson@spenshult.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: December 11, 2017
• Study Start: November 1, 2017
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: December 22, 2017

Record last verified: 2017-12

Locations

SE (1)