Low Back PainNCT03940456
Prognostic Factors of Importance on Who Develops Chronic Low Back Pain
An observational study of Low Back Pain and Life Style, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time. Read more about this study
- Who is it for?
- Ages 67 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Life Style, Illness Perception
- What is being tested?
- Questionnaire
- How many people
- 607 participants
- Where
- 1 siteDenmark
- Study dates
- 8 May 2019to 24 Sep 2019
- 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 67 to 69 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Study population will comprise all available subjects who have been part of the Elsinore cohort since 1965
Who may be able to join
- This is an inception cohort based on pupils from schools in Elsinore. There are no formal inclusion criteria other tan being part of this cohort
Who cannot join
- No formal exclusion criteria but inability to understand/answer our questionnaire is per se an exclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prognostic Factors of Importance on Who Develops Chronic Low Back Pain: A Protocol Update for an Inception Cohort With Focus on Prognostic Factors With 54 Years of Follow up
The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time.
Read the detailed description
Despite massive efforts of trying to find predictors and prevention for LBP, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain. There is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of LBP has increased continuously over the last 20 years which is also reflected in rising numbers of lumbar surgical treatments. The prevalence and burden increase with age and prevention of LBP in an aging population seems more urgent than ever. As LBP is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both life style and psychosocial factors on the development of chronic low back pain.
The aim of this study is to identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.
- Conditions
- Low Back Pain, Life Style, Illness Perception
- Being tested
- Questionnaire
- Keywords
- Cohort, Low Back Pain, Illness perception, Life Style
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain
| Study group | Role | What they receive |
|---|---|---|
| Inception cohort, former Elsinore pupils | 640 former Elsinore pupils (330 female, 310 male). Aged 14 in 1965. Two earlier cross-sectional studies have been done in this group (in 1990 and 2000). Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of LBP
To estimate the prevalence of self-disclosed low back pain
Measured: measured once at study baseline
Secondary outcomes (3)
Incidence of LBP
To estimate the incidence of self-disclosed low back pain
Measured: measured once at study baseline
Brief illness perception questionnaire (IPQ-B)
Actual IPQ-B score. Generic questionnaire developed to measure illness perception. The IPQ-B contains eight items and one causal scale. Items 1-8 are rated using a 0-to-10 response scale, item 9 is a memo field. Five of the items assess cognitive illness representations: consequences (Item 1), timeline (Item 2), personal control (Item 3), treatment control (Item 4), and identity (Item 5). Two of the items assess emotional representations: concern (Item 6) and emotions (Item 8). One item assesses illness comprehensibility (Item 7).
A low score on items number 1,2,5,6 and 8 indicates that the illness is perceived as benign while a low score on the items 3, 4 and 7 indicates that the illness is perceived as threatening. By reversing these three items it is possible to compute an overall score. A higher score reflects a more threatening view of the illness.
Measured: measured once at study baseline
EQ-5D (3 likert scale)
The EQ-5D-3L essentially consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS) (0-100). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems. The EQ VAS records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). This information can be used as a quantitative measure of health outcome as judged by the individual respondents. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: measured once at study baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start8 May 2019
- Primary completion24 Sep 2019
- Study completion24 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low 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
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940456
- Sponsor's protocol ID
- Elsinore low back pain cohort
- Status last verified
- Sep 2020
- First submitted
- 29 Apr 2019
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors of Importance on Who Develops Chronic Low Back Pain: A Protocol Update for an Inception Cohort With Focus on Prognostic Factors With 54 Years of Follow up
- ClinicalTrials.gov ID
- NCT03940456
- Acronym / sponsor ID
- Elsinore low back pain cohort
- Conditions
- Low Back Pain, Life Style, Illness Perception
- Keywords
- Cohort, Low Back Pain, Illness perception, Life Style
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 8 May 2019 (actual)
- Primary completion
- 24 Sep 2019 (actual)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 7 May 2019 (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.
The incidence of low back pain (LBP) is increasing and prognostic factors for developing LBP are unclear. Based on questionnaires, different prognostic factors are being explored over time.
Detailed description
Despite massive efforts of trying to find predictors and prevention for LBP, it remains to be clarified, why some individuals develop severely disabling low back pain while others never experience noteworthy back pain. There is no evidence that numbers of chronically affected individuals have diminished; rather, the incidence of LBP has increased continuously over the last 20 years which is also reflected in rising numbers of lumbar surgical treatments. The prevalence and burden increase with age and prevention of LBP in an aging population seems more urgent than ever. As LBP is undoubtedly a multifaceted disorder that tends to fluctuate throughout life, there is a need for longitudinal research, exploring the effect of both life style and psychosocial factors on the development of chronic low back pain.
The aim of this study is to identify whether a history of low back pain during adolescence represents an increased risk of experiencing low back pain later in life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inception cohort, former Elsinore pupils | – | Other: Questionnaire640 former Elsinore pupils (330 female, 310 male). Aged 14 in 1965. Two earlier cross-sectional studies have been done in this group (in 1990 and 2000). |
Who may qualify
- Ages
- 67 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Study population will comprise all available subjects who have been part of the Elsinore cohort since 1965
Key inclusion criteria (1 listed)
- This is an inception cohort based on pupils from schools in Elsinore. There are no formal inclusion criteria other tan being part of this cohort
Key exclusion criteria (1 listed)
- No formal exclusion criteria but inability to understand/answer our questionnaire is per se an exclusion criteria
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 |
|---|---|---|
| QuestionnaireQuestionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain | Other | Inception cohort, former Elsinore pupils |
Primary outcome
prevalence of LBP
Time frame: measured once at study baseline
To estimate the prevalence of self-disclosed low back pain
3 secondary outcomes
Incidence of LBP
Time frame: measured once at study baseline
Brief illness perception questionnaire (IPQ-B)
Time frame: measured once at study baseline
EQ-5D (3 likert scale)
Time frame: measured once at study baseline
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 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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 Low Back Pain and Life Style, run by Frederiksberg University Hospital at 1 site in Denmark.
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 1 inclusion and 1 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 27 Feb 2025. 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 Denmark. 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?
prevalence of LBP (time frame: measured once at study baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Feb 2025.