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CompletedNCT03940456Updated Feb 27, 2025

Prognostic Factors of Importance on Who Develops Chronic Low Back Pain

An observational study in Low Back Pain, Life Style and Illness Perception, sponsored by Frederiksberg University Hospital. Completed at 1 site in Denmark. Open to participants aged 67 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Frederiksberg University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
607
Ages
67 Years to 69 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Low Back Pain
  • Life Style
  • Illness Perception

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Keywords

  • Cohort
  • Low Back Pain
  • Illness perception
  • Life Style
03

In context

Low Back Pain

2,875 studies on the registry are indexed under Low Back Pain; 484 are open to participants now.

This study's enrollment of 607 is above the median of 100 across 483 observational studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Frederiksberg University Hospital is the lead sponsor of 41 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
67 Years to 69 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Study population will comprise all available subjects who have been part of the Elsinore cohort since 1965

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No formal exclusion criteria but inability to understand/answer our questionnaire is per se an exclusion criteria
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
607 participants (actual)
Patient registry
No

Groups and cohorts

  • 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).

    Other: Questionnaire

Interventions

  • OtherQuestionnaire

    Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain

06

What researchers measure

Primary outcomes

  1. prevalence of LBP

    To estimate the prevalence of self-disclosed low back pain

    Time frame: measured once at study baseline

Secondary outcomes

  1. Incidence of LBP

    To estimate the incidence of self-disclosed low back pain

    Time frame: measured once at study baseline

  2. 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.

    Time frame: measured once at study baseline

  3. 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.

    Time frame: measured once at study baseline

07

Study locations

1 site
  • The Parker Institute, Frederiksberg Hospital
    Copenhagen, 2000, Denmark
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03940456
Lead sponsor
Frederiksberg University Hospital
Responsible party
Marius Henriksen (Professor, Frederiksberg University Hospital) — Principal investigator
First posted
May 7, 2019
Start date
May 8, 2019
Primary completion
Sep 24, 2019
Completion
Sep 24, 2019
Last update
Feb 27, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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