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Implementation of a Best Practice Primary Health Care Model for Low Back Pain (BetterBack)

L

Linköping University (LiU)

Status

Completed

Conditions

Low Back Pain

Treatments

Behavioral: Multifaceted implementation of the BetterBack
Behavioral: Current routine practice

Study type

Interventional

Funder types

Other

Identifiers

NCT03147300
BetterBack

Details and patient eligibility

About

POPULATION: Low back pain (LBP) is a major health problem commonly requiring health care. In Sweden, primary care professionals require an evidenced based model of care for LBP.

INTERVENTION: The multi-faceted implementation of a best practice BetterBack model of care for LBP.

CONTROL: Current routine practice for LBP care before implementation of the BetterBack model of care.

OUTCOME: Patient reported measures (function, activity, health), therapist reported measures (diagnosis, intervention, specialist referral, best practice self-confidence, determinants of implementation) and cost-effectiveness.

AIM: To deliver best practice recommendations for LBP and study their most effective implementation through the BetterBack model of care.

METHOD: A cluster randomised trial with dog leg design. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist outcomes as well as cost-effectiveness compared to current routine care.

Full description

Low back pain (LBP) is a major health and socioeconomic burden. LBP is usually a result of benign dysfunction and context that affects the patient's perception of pain and limits their activity and participation. At present there are no national clinical guidelines or best practice models of care in Sweden focused on the primary care of low back pain. Implementation of a model of LBP primary care based on international evidence-based guidelines is needed to improve care and patient outcomes in Sweden. This project aims to investigate the effectiveness of a best practice model of care (BetterBack) for the primary care management of LBP. A cluster randomised trial with dog leg design will be conducted in the Östergötland Health care region. The hypothesis is that the BetterBack model of care will result in significantly better patient and therapist reported outcomes as well as cost-effectiveness compared to current routine care. This by improved patient outcomes in terms of physical function, low back pain intensity, activity level, work and quality of life. Furthermore, improved care processes and knowledge support for physiotherapists can lead to a smaller proportion of patients requiring specialist care.

Enrollment

467 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Health care practictioner sample

Inclusion Criteria:

  • Registered physiotherapists practicing in the allocated clinics and regularly working with patients with LBP

Patient sample

Inclusion Criteria:

  • Males and females 18-65 years; Fluent in Swedish; Accessing public primary care due to a current episode of a first-time or recurrent debut of benign low back pain with or without radiculopathy

Exclusion Criteria:

  • Current diagnosis of malignancy, spinal fracture, infection, cauda equine syndrome, ankylosing spondylitis or systemic rheumatic disease, previous malignancy during the past 5 years; Current pregnancy or previous pregnancy up to 3 months before consideration of inclusion; Patients that fulfill criteria for multimodal/multi-professional rehabilitation for complex longstanding pain; Severe psychiatric diagnosis

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

467 participants in 2 patient groups

Östergötland region - Control group
Active Comparator group
Treatment:
Behavioral: Current routine practice
Östergötland region - Intervention group
Experimental group
Treatment:
Behavioral: Multifaceted implementation of the BetterBack

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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