Back PainBACE-NNCT04261309
BACk Pain in Elders in Norway (BACE-N)
An observational study of Back Pain, run by Oslo Metropolitan University at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Back Pain
- How many people
- 452 participants
- Where
- 1 siteNorway
- Study dates
- 15 Jan 2017to 15 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- seek primary care (GP, physiotherapist or chiropractor)
- new episode of back pain
- no visit of primary care the preceding 6 months for back pain
Who cannot join
- cognitive impairments
- difficulties speaking and writing Norwegian
- severe mobility impairments (can not attend physical examination)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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:
- 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
- Establish the 1- and 2-year clinical course (overall prognosis) and burden of back-related disability (defined as the primary outcome)
- 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)
- 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
- 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
- Develop and validate a prognostic model for long-term back-related disability at 1- and 2-years follow-up in these people
- Explore prognostic factors associated with persistent and/or recurrent back pain at 1- and 2 years follow-up
- Explore prognostic factors associated with costs of illness during 1-year of follow-up
- 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
- 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.
- 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.
- Conditions
- Back Pain
- Being tested
- Usual care
- Keywords
- prognosis, prognostic factors, subgroups, burden of disease,
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Roland Morris Disability Questionnaire
Scores range from 0 to 24. Higher scores indicate more severe pain and disability.
Measured: 12 months follow-up
the Roland Morris Disability Questionnaire
Scores range from 0 to 24. Higher scores indicate more severe pain and disability.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (10)
Overall recovery
Global perceived effect scale (7-point ordinal scale)
Measured: 12 months follow-up
Overall recovery
Global perceived effect scale (7-point ordinal scale)
Measured: 24 months follow-up
Costs of healthcare utilization
Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.
Measured: 12 months follow-up
Costs of healthcare utilization
Costs summarised for type and frequency of health care, including consultations, medication, treatment, diagnostic examinations, hospitalisation/institutionalisation, and operations.
Measured: 24 months follow-up
Number of falls during follow-up
number of falls, including description of cause of the fall
Measured: 12 months follow-up
Number of falls during follow-up
number of falls, including description of cause of the fall
Measured: 24 months follow-up
Insomnia
Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.
Measured: 12 months follow-up
Insomnia
Bergen Insomnia Scale, 6 items assessing sleep onsent, maintenance and early morning wakening insomnia.
Measured: 24 months follow-up
Symptomatic State
the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)
Measured: 12 months follow-up
Symptomatic State
the Patient Acceptable Symptomatic State (PASS) (5-point ordinal scale)
Measured: 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start15 Jan 2017
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, University of Sydney, University of Rotterdam, The Netherlands, University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Principal investigator, Margreth Grotle, Oslo Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261309
- Sponsor's protocol ID
- BACE
- Acronym
- BACE-N
- Status last verified
- Feb 2024
- First submitted
- 30 Jan 2020
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: BACE-N is part of the international BACE consortium. We plan to share BACE-N with other BACE researchers in the Netherlands.
Publications
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.
PubMed 40850922Grondahl 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.
PubMed 38216905Vigdal 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.
PubMed 37490100Vigdal 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.
PubMed 36083174Killingmo 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.
PubMed 35725262Killingmo 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.
PubMed 35717179Vigdal 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.
PubMed 34535487
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04261309
- Acronym / sponsor ID
- BACE-N / BACE
- Conditions
- Back Pain
- Keywords
- prognosis, prognostic factors, subgroups, burden of disease,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Oslo Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Oslo University Hospital, University of Sydney, University of Rotterdam, The Netherlands, University of Bergen, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- 15 Jan 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- Establish the 1- and 2-year clinical course (overall prognosis) and burden of back-related disability (defined as the primary outcome)
- 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)
- 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
- 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
- Develop and validate a prognostic model for long-term back-related disability at 1- and 2-years follow-up in these people
- Explore prognostic factors associated with persistent and/or recurrent back pain at 1- and 2 years follow-up
- Explore prognostic factors associated with costs of illness during 1-year of follow-up
- 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
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly with back pain in primary healthcare | – | Other: Usual careConsecutive 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) |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- seek primary care (GP, physiotherapist or chiropractor)
- new episode of back pain
- no visit of primary care the preceding 6 months for back pain
Key exclusion criteria (3 listed)
- cognitive impairments
- difficulties speaking and writing Norwegian
- severe mobility impairments (can not attend physical examination)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careSince 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. | Other | Elderly with back pain in primary healthcare |
Primary outcome
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.
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.
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.
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.
10 secondary outcomes
Overall recovery
Time frame: 12 months follow-up
Overall recovery
Time frame: 24 months follow-up
Costs of healthcare utilization
Time frame: 12 months follow-up
Costs of healthcare utilization
Time frame: 24 months follow-up
Number of falls during follow-up
Time frame: 12 months follow-up
Number of falls during follow-up
Time frame: 24 months follow-up
Insomnia
Time frame: 12 months follow-up
Insomnia
Time frame: 24 months follow-up
Symptomatic State
Time frame: 12 months follow-up
Symptomatic State
Time frame: 24 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 40850922Sannes 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.
- Derived from this study: PubMed 38216905Grondahl 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.
- Derived from this study: PubMed 37490100Vigdal 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.
- Derived from this study: PubMed 36083174Vigdal 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.
- Derived from this study: PubMed 35725262Killingmo 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.
- Derived from this study: PubMed 35717179Killingmo 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.
- Derived from this study: PubMed 34535487Vigdal 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.
- Individual participant dataSharing planned: Yes. BACE-N is part of the international BACE consortium. We plan to share BACE-N with other BACE researchers in the Netherlands.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Back Pain, run by Oslo Metropolitan University at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Roland Morris Disability Questionnaire (time frame: 12 months follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261309, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.