Clinical trial NCT04261309: BACk Pain in Elders in Norway (BACE-N)
Official title: BACk Pain in Elders in Norway (BACE-N); A Prospective Cohort Study of Older People Visiting Primary Care With a New Episode of Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Keywords: prognosis, prognostic factors, subgroups, burden of disease,
Lead sponsor: Oslo Metropolitan University
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: University of Sydney
name: University of Rotterdam, The Netherlands
name: University of Bergen
name: Norwegian Fund for Postgraduate Training in Physiotherapy
First posted: 2020-02-07
Enrollment: 452
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients are recruited from a range of general practitioners (GPs), physiotherapists (PTs), and chiropractors working in the primary care in Norway. Patients who fit the eligibility criteria and complete the consent to participate respond to a comprehensive baseline questionnaire and undergo a standardised physical examination. The questionnaire is preferably completed electronically, but a paper version is also available for patients who are not familiar with an electronic data collection.

Brief summary: An international Consortium (BACk pain in Elders: BACE) was established in 2008 in order to create standardised methodology for large cohort studies and share data on the burden of back pain in older people. BACE cohort studies have been established in several countries with the primary objective to establish the clinical course and burden of back pain in elderly, to identify prognostic factors for chronic back pain and disability, and to explore usual care provided in primary care. The BACE-N is a BACE cohort study conducted in Norway, including a broad network of clinicians covering general practitioners, physiotherapists and chiropractors working in the primary healthcare. The BACE-N project will provide new knowledge on prognosis of back-related disability and pain in elderly people who seek help in the primary healthcare, the clinical course of back pain over two follow-up years, including a thorough description of healthcare utilisation and their costs, and prognostic factors that influence good or poor prognosis for these people.

Detailed description: Back pain represent a considerable burden worldwide, and is predominantly managed in primary care. Between 2010 and 2050, the number of people aged 60 years and older will increase by 56% in developed countries, and this transition will increase the burden of chronic back disability. Most previous studies on (low) back pain have excluded people above 60 years of age, leading to a large knowledge gap regarding the prognosis of back-related disability and pain in older people and which factors influence the transition from acute to chronic stage. Further, back pain outcomes used in the few existing studies are not selected to capture the burden and characterization of back pain in older people. Therefore, the international Consortium (BACk pain in Elders: BACE) was established in 2008 in order to create standardised methodology for large cohort studies and share data on the burden of back pain in older people. BACE cohort studies have been established in several countries, also currently in Norway, with the primary objective to establish the clinical course and burden of back pain in elderly, to identify prognostic factors for chronic back pain and disability, and to explore usual care provided in primary care.

Specific aims for the BACE-N are:

1. Explore potential differences in baseline characteristics, including main domains of measurements of putative prognostic factors and outcomes, across patients who seek general practitioner, physiotherapist and chiropractor in primary care
2. Establish the 1- and 2-year clinical course (overall prognosis) and burden of back-related disability (defined as the primary outcome)
3. Establish the 1- and 2-year clinical course (overall prognosis) and burden of pain (severity, location/radiation/neurological signs, stiffness, sleep, and use of pain medication)
4. Describe usual care provided in the primary care (for the initial episode of back pain) and cost of illness due to total healthcare consumption (including secondary care such as hospitalisation and institutionalisation) and production loss during one year of follow-up
5. Assess the association between established prognostic factors in the middle-aged back pain population (comorbidity and psychosocial profile) and back-related disability at 1-and 2-years follow-up
6. Develop and validate a prognostic model for long-term back-related disability at 1- and 2-years follow-up in these people
7. Explore prognostic factors associated with persistent and/or recurrent back pain at 1- and 2 years follow-up
8. Explore prognostic factors associated with costs of illness during 1-year of follow-up
9. Establish the 1- and 2-year incidence of falls and loss of independence (Falls Efficacy Scale) and explore prognostic factors associated with falls and loss of independence during 1- and 2-year of follow-up
10. Assess the clinical course (overall prognosis) in main outcomes (disability, pain, and costs of illness) across patients who seek general practitioner, physiotherapist and chiropractor in primary care.
11. Assess gender differences in clinical course, prognostic factors and usual care in these people.

In addition to these specific aims, the BACE-N includes several methodological studies as several of the measurements from the original BACE protocol had to be translated and validated for a Norwegian context.

The study design is a prospective observational cohort study with linked methodological studies within a primary care setting, recruiting 450 patients from three main back pain health professionals; general practitioners, physiotherapists and chiropractors. The patients are followed by questionnaire at 3, 6, 12 and 24 months after inclusion. The data collected in the BACE-N adheres to the standardised methods described in the published protocol from 2011 (Scheele J, Luijsterburg PA, Ferreira ML, Maher CG, Pereira L, Peul WC, et al. Back complaints in the elders (BACE); design of cohort studies in primary care: an international consortium. BMC Musculoskelet Disord. 2011;12:193). Likewise, the statistical approach adheres to the original plan and the PROGnosis RESearch Strategy (PROGRESS), covering overall prognosis research, prognostic factor research, and prognostic model research. The methodological studies in the BACE-N are conducted in line with the COSMIN recommendations. A protocol for the BACE-N will be registered.

Eligibility criteria: Inclusion Criteria:

* seek primary care (GP, physiotherapist or chiropractor)
* new episode of back pain
* no visit of primary care the preceding 6 months for back pain

Exclusion Criteria:

* cognitive impairments
* difficulties speaking and writing Norwegian
* severe mobility impairments (can not attend physical examination)

Primary outcomes:
measure: the Roland Morris Disability Questionnaire
timeFrame: 12 months follow-up
measure: the Roland Morris Disability Questionnaire
timeFrame: 24 months follow-up
measure: Numerical Pain Rating Scale
timeFrame: 12 months follow-up
measure: Numerical Pain Rating Scale
timeFrame: 24 months
Secondary outcomes:
measure: Overall recovery
timeFrame: 12 months follow-up
measure: Overall recovery
timeFrame: 24 months follow-up
measure: Costs of healthcare utilization
timeFrame: 12 months follow-up
measure: Costs of healthcare utilization
timeFrame: 24 months follow-up
measure: Number of falls during follow-up
timeFrame: 12 months follow-up
measure: Number of falls during follow-up
timeFrame: 24 months follow-up
measure: Insomnia
timeFrame: 12 months follow-up
measure: Insomnia
timeFrame: 24 months follow-up
measure: Symptomatic State
timeFrame: 12 months follow-up
measure: Symptomatic State
timeFrame: 24 months follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Tåsen og Ullevål fysioterapi
Study officials:
References:
citation: Vigdal ON, Storheim K, Killingmo RM, Smastuen MC, Grotle M. The one-year clinical course of back-related disability and the prognostic value of comorbidity among older adults with back pain in primary care. Pain. 2023 Apr 1;164(4):e207-e216. doi: 10.1097/j.pain.0000000000002779. Epub 2022 Sep 8.
citation: Killingmo RM, Storheim K, van der Windt D, Zolic-Karlsson Z, Vigdal ON, Kretz L, Smastuen MC, Grotle M. Healthcare utilization and related costs among older people seeking primary care due to back pain: findings from the BACE-N cohort study. BMJ Open. 2022 Jun 20;12(6):e057778. doi: 10.1136/bmjopen-2021-057778.
citation: Killingmo RM, Chiarotto A, van der Windt DA, Storheim K, Bierma-Zeinstra SMA, Smastuen MC, Zolic-Karlsson Z, Vigdal ON, Koes BW, Grotle M. Modifiable prognostic factors of high costs related to healthcare utilization among older people seeking primary care due to back pain: an identification and replication study. BMC Health Serv Res. 2022 Jun 18;22(1):793. doi: 10.1186/s12913-022-08180-2.
citation: Vigdal ON, Storheim K, Munk Killingmo R, Smastuen MC, Grotle M. Characteristics of older adults with back pain associated with choice of first primary care provider: a cross-sectional analysis from the BACE-N cohort study. BMJ Open. 2021 Sep 17;11(9):e053229. doi: 10.1136/bmjopen-2021-053229.