BACk Pain in Elders in Norway (BACE-N)

Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04261309
• Other study ID #: BACE
• Status: Completed
• Start date: January 15, 2017
• Est. completion date: March 15, 2022

Study information

• Verified date: February 2024
• Source: Oslo Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 452
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Back Pain

Intervention

Other:
• Usual care
Since this is an observational study there will be no interference with the care given by the primary healthcare providers. However, the usual care provided by these and other healthcare utilization used by the patients during follow-up will be recorded during the follow-ups.

Locations

Country	Name	City	State
Norway	Tåsen og Ullevål fysioterapi	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Oslo Metropolitan University	Norwegian Fund for Postgraduate Training in Physiotherapy, Oslo University Hospital, University of Bergen, University of Rotterdam, The Netherlands, University of Sydney

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Roland Morris Disability Questionnaire	Scores range from 0 to 24. Higher scores indicate more severe pain and disability.	12 months follow-up
Primary	the Roland Morris Disability Questionnaire	Scores range from 0 to 24. Higher scores indicate more severe pain and disability.	24 months follow-up
Primary	Numerical Pain Rating Scale	pain severity for back and leg pain assessed on a score from 0 (no pain) to 10 (maximum pain). Back and leg pain is scored separately.	12 months follow-up
Primary	Numerical Pain Rating Scale	pain severity for back and leg pain assessed on a score from 0 (no pain) to 10 (maximum pain). Back and leg pain is scored separately.	24 months
Secondary	Overall recovery	Global perceived effect scale (7-point ordinal scale)	12 months follow-up
Secondary	Overall recovery	Global perceived effect scale (7-point ordinal scale)	24 months follow-up
Secondary	Costs of healthcare utilization	Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.	12 months follow-up
Secondary	Costs of healthcare utilization	Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.	24 months follow-up
Secondary	Number of falls during follow-up	number of falls, including description of cause of the fall	12 months follow-up
Secondary	Number of falls during follow-up	number of falls, including description of cause of the fall	24 months follow-up
Secondary	Insomnia	Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.	12 months follow-up
Secondary	Insomnia	Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.	24 months follow-up
Secondary	Symptomatic State	the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)	12 months follow-up
Secondary	Symptomatic State	the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)	24 months follow-up