- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04739839
Risk Factors for Low Back Pain in Adults a 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.
Study Overview
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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DK
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Copenhagen, DK, Denmark, 2000
- Claus Bomhoff
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
We have no formal exclusion criterias
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of low back pain
Time Frame: Measured once at study baseline
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Amount of respondents reporting low back pain within last month
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Measured once at study baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence of severe low back pain
Time Frame: Measured once at study baseline
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Amount of respondents reporting low back pain more than thirty days within last year
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Measured once at study baseline
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Actual low back pain
Time Frame: Measured once at study baseline
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Current low back pain, defined as "the level of pain in your lower back today"
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Measured once at study baseline
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The Brief Illness Perception Questionnaire
Time Frame: Measured once at study baseline
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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 once at study baseline
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Roland Morris Questionnaire
Time Frame: Measured once at study baseline
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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.
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Measured once at study baseline
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Health related quality of life EQ-5D
Time Frame: Measured once at study baseline
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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.
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Measured once at study baseline
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Health related quality of life EQ-5D VAS
Time Frame: Measured once at study baseline
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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.
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Measured once at study baseline
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Use of CAMs for low back pain
Time Frame: Measured once at study baseline
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Amount of respondents reporting regular use of complementary or alternative treatments (CAMs) for low back pain
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Measured once at study baseline
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Use of exercise for low back pain
Time Frame: Measured once at study baseline
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Amount of respondents doing regular exercise for low back pain
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Measured once at study baseline
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Use of recommended non-pharmacological treatments for low back pain
Time Frame: Measured once at study baseline
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Amount of respondents reporting regular use of recommended non-pharmacological treatments for low back pain
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Measured once at study baseline
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Use of recommended pharmacological treatments for low back pain
Time Frame: Measured once at study baseline
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Amount of respondents reporting regular use of recommended pharmacological treatments for low back pain
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Measured once at study baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Western Zealand Cohort
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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