Low Back PainNCT04739839
Risk Factors for Low Back Pain in Adults a 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.
An observational study of Low Back Pain, 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 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- survey questionnaire
- How many people
- 1,400 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Feb 2021to 30 Mar 2021
- 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 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This is an inception cohort where all participants will be around 38 years
Who may be able to join
- Being a member of the original Western Zealand cohort
- Ability to understand and write in Danish
- Having access to the Danish digital mail system "e-Boks". (Access to e-Boks is mandatory in Denmark unless you have special needs)
Who cannot join
- We have no formal exclusion criterias
Trial locations and contacts
1 site in 1 country.
About this study
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 the 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 and rising costs due to health care expenses and sick leave. Hence, prevention of LBP in the working 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 lifestyle and psychosocial factors on the development of chronic low back pain.
The main aims of this study is to identify the prevalence of low back pain and 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
- Being tested
- survey questionnaire
- Keywords
- low back pain, prevalence, illness perception, quality of life, cohort study, survey
- 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.
survey questionnaireOther
Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.
| Study group | Role | What they receive |
|---|---|---|
| Inception cohort, former pupils in different schools in Western Zealand | 1327 former Western Zealand pupils (originally 1389). Aged 14-15 in 1997. This is the first follow up on this cohort. Receives: Other: survey questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of low back pain
Amount of respondents reporting low back pain within last month
Measured: Measured once at study baseline
Secondary outcomes (10)
Incidence of severe low back pain
Amount of respondents reporting low back pain more than thirty days within last year
Measured: Measured once at study baseline
Actual low back pain
Current low back pain, defined as "the level of pain in your lower back today"
Measured: Measured once at study baseline
The Brief Illness Perception Questionnaire
We use the Danish version of The Brief illness perception questionnaire (B-IPQ). B-IPQ is a generic 9-item questionnaire developed to rapidly assess the cognitive and emotional representations in a variety of illnesses. The first 8 items are scored on a 1-10 numeric rating scale with descriptors (none or extreme) at either end. B-IPQ assesses perceptions on the following five dimensions: Identity, Cause, Timeline, Consequences and Cure-Control. Five of the items assess cognitive illness representations: consequences, timeline, personal control, treatment control, and identity. Two of the items assess emotional representations: concern and emotions. One item assesses illness comprehensibility. Item 9 is a free text field in which the respondent can formulate their beliefs about their condition (cause). We will not use this field in our study. In all questions we replace the word "illness" with "low back pain".
In this study we explore each B-IPQ item score and not an overall score.
Measured: Measured once at study baseline
Roland Morris Questionnaire
The Roland Morris Questionnaire (RMQ) is designed to assess self-rated physical disability caused by low back pain. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. It is easy to administer and correlates well with other physical disability measures. We used the Danish version (RMQ-Patrick). It has 23 questions with yes/no options and is translated in 2003. A clinically meaningful change on the RMQ ranges from a 2.5- to a 5.0-point improvement (reduction) from baseline has been suggested.
Measured: Measured once at study baseline
Health related quality of life EQ-5D
To assess health related quality of life we apply the Danish version of the EuroQoL 5 dimensions (EQ-5D) questionnaire. EQ-5D is a standardised measure of health status that provides a simple, generic measure of health. It is applicable to a wide range of health conditions and is ideally suited for use in surveys. The EQ-5D consists of a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Standardized answer options are given (3 Likert boxes) and each question is assigned a score from 1 to 3. From the responses an EQ-5D index is calculated. Further a EQ visual analogue scale (EQ VAS) is used to record the respondent's self-rated health on a 0-100 vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' used as a quantitative measure of health as judged by the individual respondents.
Measured: Measured once at study baseline
Health related quality of life EQ-5D VAS
A visual analogue scale (EQ VAS) is used to record the respondent's self-rated health on a 0-100 vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine' used as a quantitative measure of health as judged by the individual respondents.
Measured: Measured once at study baseline
Use of CAMs for low back pain
Amount of respondents reporting regular use of complementary or alternative treatments (CAMs) for low back pain
Measured: Measured once at study baseline
Use of exercise for low back pain
Amount of respondents doing regular exercise for low back pain
Measured: Measured once at study baseline
Use of recommended non-pharmacological treatments for low back pain
Amount of respondents reporting regular use of recommended non-pharmacological treatments for low back pain
Measured: Measured once at study baseline
Use of recommended pharmacological treatments for low back pain
Amount of respondents reporting regular use of recommended pharmacological treatments for low back pain
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 posted5 Feb 2021
- Study start5 Feb 2021
- Primary completion30 Mar 2021
- Study completion30 Mar 2021
Why it stopped: Lack of responders
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
- 1,400 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
- NCT04739839
- Sponsor's protocol ID
- Western Zealand Cohort
- Status last verified
- Jan 2022
- First submitted
- 1 Feb 2021
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available through request to study contact person
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
- Risk Factors for Low Back Pain in Adults a 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.
- ClinicalTrials.gov ID
- NCT04739839
- Acronym / sponsor ID
- Western Zealand Cohort
- Conditions
- Low Back Pain
- Keywords
- low back pain, prevalence, illness perception, quality of life, cohort study, survey
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of responders
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 5 Feb 2021 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 5 Feb 2021 (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 the 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 and rising costs due to health care expenses and sick leave. Hence, prevention of LBP in the working 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 lifestyle and psychosocial factors on the development of chronic low back pain.
The main aims of this study is to identify the prevalence of low back pain and 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 pupils in different schools in Western Zealand | – | Other: survey questionnaire1327 former Western Zealand pupils (originally 1389). Aged 14-15 in 1997. This is the first follow up on this cohort. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This is an inception cohort where all participants will be around 38 years
Key inclusion criteria (3 listed)
- Being a member of the original Western Zealand cohort
- Ability to understand and write in Danish
- Having access to the Danish digital mail system "e-Boks". (Access to e-Boks is mandatory in Denmark unless you have special needs)
Key exclusion criteria (1 listed)
- We have no formal exclusion criterias
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 |
|---|---|---|
| survey questionnaireQuestionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life. | Other | Inception cohort, former pupils in different schools in Western Zealand |
Primary outcome
Incidence of low back pain
Time frame: Measured once at study baseline
Amount of respondents reporting low back pain within last month
10 secondary outcomes
Incidence of severe low back pain
Time frame: Measured once at study baseline
Actual low back pain
Time frame: Measured once at study baseline
The Brief Illness Perception Questionnaire
Time frame: Measured once at study baseline
Roland Morris Questionnaire
Time frame: Measured once at study baseline
Health related quality of life EQ-5D
Time frame: Measured once at study baseline
Health related quality of life EQ-5D VAS
Time frame: Measured once at study baseline
Use of CAMs for low back pain
Time frame: Measured once at study baseline
Use of exercise for low back pain
Time frame: Measured once at study baseline
Use of recommended non-pharmacological treatments for low back pain
Time frame: Measured once at study baseline
Use of recommended pharmacological treatments for low back pain
Time frame: Measured once at study baseline
Results and safety
The study was stopped early (reason given: Lack of responders). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. Data will be available through request to study contact person
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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, 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 3 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: stopped early, 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 was stopped early (reason given: Lack of responders). Results are not available in the source record.
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?
Incidence of low back pain (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.