Risk Factors for Low Back Pain in Adults a 23-year Prospective Cohort Study of 14-15-year-old Schoolchildren.

February 25, 2025 updated by: Marius Henriksen, Frederiksberg University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

1400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • DK
      • Copenhagen, DK, Denmark, 2000
        • Claus Bomhoff

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

This is an inception cohort where all participants will be around 38 years

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of low back pain
Time Frame: Measured once at study baseline
Amount of respondents reporting low back pain within last month
Measured once at study baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of severe low back pain
Time Frame: Measured once at study baseline
Amount of respondents reporting low back pain more than thirty days within last year
Measured once at study baseline
Actual low back pain
Time Frame: Measured once at study baseline
Current low back pain, defined as "the level of pain in your lower back today"
Measured once at study baseline
The Brief Illness Perception Questionnaire
Time Frame: Measured once at study baseline

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
Roland Morris Questionnaire
Time Frame: Measured once at study baseline
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 once at study baseline
Health related quality of life EQ-5D
Time Frame: Measured once at study baseline
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 once at study baseline
Health related quality of life EQ-5D VAS
Time Frame: Measured once at study baseline
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 once at study baseline
Use of CAMs for low back pain
Time Frame: Measured once at study baseline
Amount of respondents reporting regular use of complementary or alternative treatments (CAMs) for low back pain
Measured once at study baseline
Use of exercise for low back pain
Time Frame: Measured once at study baseline
Amount of respondents doing regular exercise for low back pain
Measured once at study baseline
Use of recommended non-pharmacological treatments for low back pain
Time Frame: Measured once at study baseline
Amount of respondents reporting regular use of recommended non-pharmacological treatments for low back pain
Measured once at study baseline
Use of recommended pharmacological treatments for low back pain
Time Frame: Measured once at study baseline
Amount of respondents reporting regular use of recommended pharmacological treatments for low back pain
Measured once at study baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2021

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

March 30, 2021

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 25, 2025

Last Verified

January 1, 2022

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)?

NO

IPD Plan Description

Data will be available through request to study contact person

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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