BACk Pain in Elders in Norway (BACE-N)

NCT04261309 | Completed

• 1 other identifier: BACE
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Keywords

prognosis, prognostic factors, subgroups, burden of disease,

Outcome Measures

Primary Outcomes (4)

• the Roland Morris Disability Questionnaire

  Scores range from 0 to 24. Higher scores indicate more severe pain and disability.

  12 months follow-up

• the Roland Morris Disability Questionnaire

  Scores range from 0 to 24. Higher scores indicate more severe pain and disability.

  24 months follow-up

• 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

• 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 Outcomes (10)

• Overall recovery

  12 months follow-up

• Overall recovery

  24 months follow-up

• Costs of healthcare utilization

  12 months follow-up

• Costs of healthcare utilization

  24 months follow-up

• Number of falls during follow-up

  12 months follow-up

Study Arms (1)

Elderly with back pain in primary healthcare

Consecutive women and men 55 years of age or older who seek primary care (GP, physiotherapist or chiropractor) with a new episode of back pain (preceded by 6 months without visiting a primary care provider for similar complaints)

Other: Usual care

Interventions

Usual care OTHER

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.

Elderly with back pain in primary healthcare

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Oslo Metropolitan University: lead
• Oslo University Hospital: collaborator
• University of Sydney: collaborator
• University of Rotterdam, The Netherlands: collaborator
• University of Bergen: collaborator
• Norwegian Fund for Postgraduate Training in Physiotherapy: collaborator

Study Sites (1)

Tåsen og Ullevål fysioterapi

Oslo, 0876, Norway

Location

Related Publications (7)

• Sannes AC, Feller D, Pripp AH, Chiarotto A, Kretz Grondahl L, Killingmo RM, Axen I, Storheim K, Grotle M, Vigdal ON. Development, internal and external validation of a prognostic model for symptom dissatisfaction among older adults with a new episode of back pain. BMJ Open. 2025 Aug 24;15(8):e102318. doi: 10.1136/bmjopen-2025-102318.

  PMID: 40850922 DERIVED

• Grondahl LK, Axen I, Stensrud S, Hoekstra T, Vigdal ON, Killingmo RM, Storheim K, Grotle M. Identifying latent subgroups in the older population seeking primary health care for a new episode of back pain - findings from the BACE-N cohort. BMC Musculoskelet Disord. 2024 Jan 13;25(1):60. doi: 10.1186/s12891-024-07163-0.

  PMID: 38216905 DERIVED

• Vigdal ON, Storheim K, Killingmo RM, Rysstad T, Pripp AH, van der Gaag W, Chiarotto A, Koes B, Grotle M. External validation and updating of prognostic prediction models for nonrecovery among older adults seeking primary care for back pain. Pain. 2023 Dec 1;164(12):2759-2768. doi: 10.1097/j.pain.0000000000002974. Epub 2023 Jul 24.

  PMID: 37490100 DERIVED

• 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.

  PMID: 36083174 DERIVED

• 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.

  PMID: 35725262 DERIVED

• 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.

  PMID: 35717179 DERIVED

• 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.

  PMID: 34535487 DERIVED

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 7, 2020
• Study Start: January 15, 2017
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: from June 2021 and maximum 10 years (due to data storing policy in Norway)
• Access Criteria: Only anonymous data will be shared.

Locations

NO (1)