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BACk Pain in Elders in Norway (BACE-N) (BACE-N)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261309
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : March 29, 2021
Sponsor:
Collaborators:
Oslo University Hospital
University of Sydney
University of Rotterdam, The Netherlands
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
Information provided by (Responsible Party):
Margreth Grotle, Oslo Metropolitan University

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.

Condition or disease Intervention/treatment
Back Pain Other: Usual care

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : January 15, 2017
Estimated Primary Completion Date : June 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. the Roland Morris Disability Questionnaire [ Time Frame: 12 months follow-up ]
    Scores range from 0 to 24. Higher scores indicate more severe pain and disability.

  2. the Roland Morris Disability Questionnaire [ Time Frame: 24 months follow-up ]
    Scores range from 0 to 24. Higher scores indicate more severe pain and disability.

  3. Numerical Pain Rating Scale [ Time Frame: 12 months follow-up ]
    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.

  4. Numerical Pain Rating Scale [ Time Frame: 24 months ]
    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.


Secondary Outcome Measures :
  1. Overall recovery [ Time Frame: 12 months follow-up ]
    Global perceived effect scale (7-point ordinal scale)

  2. Overall recovery [ Time Frame: 24 months follow-up ]
    Global perceived effect scale (7-point ordinal scale)

  3. Costs of healthcare utilization [ Time Frame: 12 months follow-up ]
    Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.

  4. Costs of healthcare utilization [ Time Frame: 24 months follow-up ]
    Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.

  5. Number of falls during follow-up [ Time Frame: 12 months follow-up ]
    number of falls, including description of cause of the fall

  6. Number of falls during follow-up [ Time Frame: 24 months follow-up ]
    number of falls, including description of cause of the fall

  7. Insomnia [ Time Frame: 12 months follow-up ]
    Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.

  8. Insomnia [ Time Frame: 24 months follow-up ]
    Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.

  9. Symptomatic State [ Time Frame: 12 months follow-up ]
    the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)

  10. Symptomatic State [ Time Frame: 24 months follow-up ]
    the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261309


Contacts
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Contact: Margreth Grotle, PhD +4790111172 mgrotle@oslomet.no
Contact: Kjersti Storheim, PhD +4799708783 kjersti.storheim@medisin.uio.no

Locations
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Norway
Tåsen og Ullevål fysioterapi Recruiting
Oslo, Norway, 0876
Contact: Agnes Mordt, MSci    +4791181345    agnesc@online.no   
Contact: Kjetil Berthelsen, MSci    +4740238277    kjetil.berthelsen@ullevaltasen.no   
Sponsors and Collaborators
Oslo Metropolitan University
Oslo University Hospital
University of Sydney
University of Rotterdam, The Netherlands
University of Bergen
Norwegian Fund for Postgraduate Training in Physiotherapy
  Study Documents (Full-Text)

Documents provided by Margreth Grotle, Oslo Metropolitan University:
Study Protocol  [PDF] January 9, 2020
Statistical Analysis Plan: SAP 1  [PDF] March 11, 2021
Statistical Analysis Plan: SAP 2  [PDF] March 11, 2021
Statistical Analysis Plan: SAP 3  [PDF] March 22, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Margreth Grotle, Professor, Oslo Metropolitan University
ClinicalTrials.gov Identifier: NCT04261309    
Other Study ID Numbers: BACE
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: BACE-N is part of the international BACE consortium. We plan to share BACE-N with other BACE researchers in the Netherlands.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Margreth Grotle, Oslo Metropolitan University:
prognosis, prognostic factors, subgroups, burden of disease,
Additional relevant MeSH terms:
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Back Pain
Pain
Neurologic Manifestations